Publications by authors named "Andrew Beckett"

60 Publications

A novel inflatable device for perihepatic packing and hepatic hemorrhage control: A proof-of-concept study.

Injury 2021 Aug 28. Epub 2021 Aug 28.

Department of Haematology and Oncology St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada; Department of Surgery, Trauma and Acute Care Surgery St. Michael's Hospital and Keenan Research Center for Biomedical Sciences, University of Toronto, 30 Bond Street, Room 3073B Donnelly Wing, Toronto, Ontario M5B 1W8, Canada.

Introduction: Uncontrolled bleeding is the primary cause of death in complex liver trauma and perihepatic packing is regularly utilized for hemorrhage control. The purpose of this study was to investigate the effectiveness of a novel inflatable device (the airbag) for perihepatic packing using a validated liver injury damage control model in swine.

Material And Methods: The image of the human liver was digitally isolated within an abdominal computerized tomography scan to produce a silicone model of the liver to mold the airbag. Two medical grade polyurethane sheets were thermal bonded to the configuration of the liver avoiding compression of the hepatic pedicle, hepatic veins, and the suprahepatic vena cava after inflation. Yorkshire pigs (n = 22) underwent controlled hemorrhagic shock (35% of the total blood volume), hypothermia, and fluid resuscitation to reproduce the indications for damage control surgery (coagulopathy, hypothermia, and acidosis) prior to a liver injury. A 3 × 10 cm rectangular segment of the left middle lobe of the liver was removed to create the injury. Subsequently, the animals were randomized into 4 groups for liver damage control (240 min), Sponge Pack (n = 6), Pressurized Airbag (n = 6), Vacuum Airbag (n = 6), and Uncontrolled (n = 4). Animals were monitored throughout the experiment and blood samples obtained.

Results: Perihepatic packing with the pressurized airbag led to significantly higher mean arterial pressure during the liver damage control phase compared to sponge pack and vacuum airbag 52 mmHg (SD 2.3), 44.9 mmHg (SD 2.1), and 32 mmHg (SD 2.3), respectively (p < 0.0001), ejection fraction was also higher in that group. Hepatic hemorrhage was significantly lower in the pressurized airbag group compared to sponge pack, vacuum airbag, and uncontrolled groups; respectively 225 ml (SD 160), 611 ml (SD 123), 991 ml (SD 385), 1162 ml (SD 137) (p < 0001). Rebleeding after perihepatic packing removal was also significantly lower in the pressurized airbag group; respectively 32 ml (SD 47), 630 ml (SD 185), 513 ml (SD 303), (p = 0.0004). Intra-abdominal pressure remained similar to baseline, 1.9 mmHg (SD 1), (p = 0.297). Histopathology showed less necrosis at the border of the liver injury site with the pressurized airbag.

Conclusion: The pressurized airbag was significantly more effective at controlling hepatic hemorrhage and improving hemodynamics than the traditional sponge pack technique. Rebleeding after perihepatic packing removal was negligible with the pressurized airbag and it did not provoke hepatic injury.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.injury.2021.08.027DOI Listing
August 2021

Protocol for a multicentre, randomised, parallel-control, superiority trial comparing administration of clotting factor concentrates with a standard massive haemorrhage protocol in severely bleeding trauma patients: the FiiRST 2 trial (a 2020 EAST multicentre trial).

BMJ Open 2021 09 3;11(9):e051003. Epub 2021 Sep 3.

Anesthesia, University Health Network, Sinai Health System, and Women's College Hospital, Toronto, Ontario, Canada.

Introduction: Acute traumatic coagulopathy (ATC) in bleeding trauma patients increase in-hospital mortality. Fibrinogen concentrate (FC) and prothrombin complex concentrate (PCC) are two purified concentrates of clotting factors that have been used to treat ATC. However, there is a knowledge gap on their use compared with the standard of care, the transfusion of plasma.

Methods And Analysis: The factors in the initial resuscitation of severe trauma 2 trial is a multicentre, randomised, parallel-control, single-blinded, phase IV superiority trial. The study aims to address efficacy and safety of the early use of FC and PCC compared with a plasma-based resuscitation. Adult trauma patients requiring massive haemorrhage protocol activation on hospital arrival will receive FC 4 g and PCC 2000 IU or plasma 4 U, based on random allocation. The primary outcome is a composite of the cumulative number of all units of red cells, plasma and platelets transfused within 24 hours following admission. Secondary outcomes include measures of efficacy and safety of the intervention. Enrolment of 350 patients will provide an initial power >80% to demonstrate superiority for the primary outcome. After enrolment of 120 patients, a preplanned adaptive interim analysis will be conducted to reassess assumptions, check for early superiority demonstration or reassess the sample size for remainder of the study.

Ethics And Dissemination: The study has been approved by local and provincial research ethics boards and will be conducted according to the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. As per the Tri-Council Policy Statement, patient consent will be deferred due to the emergency nature of the interventions. If superiority is established, results will have a major impact on clinical practice by reducing exposure to non-virally inactivated blood products, shortening the time for administration of clotting factors, correct coagulopathy more efficaciously and reduce the reliance on AB plasma.

Trial Registration Number: NCT04534751, pre results.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2021-051003DOI Listing
September 2021

Ex vivo hemostatic and immuno-inflammatory profiles of freeze-dried plasma.

Transfusion 2021 07;61 Suppl 1:S119-S130

St. Michael's Hospital, Toronto, Ontario, Canada.

Background: Hemorrhage is a leading cause of preventable death in civilian and military trauma. Freeze-dried plasma is promising for hemostatic resuscitation in remote prehospital settings, given its potential benefits in reducing blood loss and mortality, long storage at ambient temperatures, high portability, and rapid reconstitution for transfusion in austere environments. Here we assess the ex vivo characteristics of a novel Terumo's freeze-dried plasma product (TFDP).

Study Design And Methods: Rotational thromboelastometry (ROTEM) tests (INTEM, EXTEM, and FIBTEM) were conducted on plasma samples at 37°C with a ROTEM delta-machine using standard reagents and procedures. The following samples were analyzed: pooled plasma to produce TFDP, TFDP reconstituted, and stored immediately at -80°C, reconstituted TFDP stored at 4°C for 24 h and room temperature (RT) for 4 h before freezing at -80°C. Analysis of plasma concentrations of selected cytokines, chemokines, and vascular molecules was performed using a multiplex immunoassay system. One-way ANOVA with post hoc tests assessed differences in hemostatic and inflammatory properties.

Results: No significant differences in ROTEM variables (coagulation time [CT], clot formation time, α-angle, maximum clot firmness, and lysis index 30) between the TFDP-producing plasma and reconstituted TFDP samples were observed. Compared to control plasma, reconstituted TFDP stored at 4°C for 24 h or RT for 4 h showed a longer INTEM CT. Levels of immuno-inflammatory mediators were similar between frozen plasma and TFDP.

Conclusions: TFDP is equivalent to frozen plasma with respect to global hemostatic and immuno-inflammatory mediator profiles. Further investigations of TFDP in trauma-induced coagulopathy models and bleeding patients are warranted.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/trf.16502DOI Listing
July 2021

Evaluation of trauma-induced coagulopathy in the fibrinogen in the initial resuscitation of severe trauma trial.

Transfusion 2021 07;61 Suppl 1:S49-S57

Department of Surgery, St. Michael's Hospital, Toronto, Ontario, Canada.

Background: Coagulopathic bleeding is frequently present after major trauma. However, trauma-induced coagulopathy (TIC) remains incompletely understood. This laboratory analysis of blood samples derived from our completed trial on fibrinogen in the initial resuscitation of severe trauma (FiiRST) was conducted to evaluate TIC and associated responses to fibrinogen replacement.

Study Design And Methods: We conducted a retrospective evaluation of TIC in 45 FiiRST trial patients based on rotational thromboelastometry (ROTEM), international normalized ratio (INR), and biomarkers for hemostasis and endotheliopathy. Whole blood was analyzed by ROTEM. Plasma was analyzed for INR and biomarkers.

Results: Overall, 19.0% and 30.0% of the FiiRST trial patients were coagulopathic on admission defined by EXTEM maximum clot firmness out of the range of 40-71 mm and INR >1.2, respectively. The FiiRST patients showed lower fibrinogen, factor II and V levels, protein C and antiplasmin activities, higher activated protein C, tissue plasminogen activator, d-dimer, and thrombomodulin concentrations at admission than healthy controls. Most of the biomarkers changed their activities during 48-h hospitalization, but were at abnormal levels even 48-h after admission. The fibrinogen treatment reduced hypofibrinogenemia and increased factor XIII level, but had no significant effects on other biomarkers levels. Limited development of endotheliopathy was indicated by syndean-1, thrombomodulin, and sE-selectin.

Conclusions: About 19%-30% of the trauma patients in the FiiRST trial were coagulopathic on hospital admission depending on the definition of TIC. Analyses of the TIC biomarkers demonstrated that hemostasis would not return to normal after 48-h hospitalization, and fibrinogen replacement improved hypofibrinogenemia.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/trf.16488DOI Listing
July 2021

Heparin for Moderately Ill Patients with Covid-19.

medRxiv 2021 Jul 12. Epub 2021 Jul 12.

Background: Heparin, in addition to its anticoagulant properties, has anti-inflammatory and potential anti-viral effects, and may improve endothelial function in patients with Covid-19. Early initiation of therapeutic heparin could decrease the thrombo-inflammatory process, and reduce the risk of critical illness or death.

Methods: We randomly assigned moderately ill hospitalized ward patients admitted for Covid-19 with elevated D-dimer level to therapeutic or prophylactic heparin. The primary outcome was a composite of death, invasive mechanical ventilation, non-invasive mechanical ventilation or ICU admission. Safety outcomes included major bleeding. Analysis was by intention-to-treat.

Results: At 28 days, the primary composite outcome occurred in 37 of 228 patients (16.2%) assigned to therapeutic heparin, and 52 of 237 patients (21.9%) assigned to prophylactic heparin (odds ratio, 0.69; 95% confidence interval [CI], 0.43 to 1.10; p=0.12). Four patients (1.8%) assigned to therapeutic heparin died compared with 18 patients (7.6%) assigned to prophylactic heparin (odds ratio, 0.22; 95%-CI, 0.07 to 0.65). The composite of all-cause mortality or any mechanical ventilation occurred in 23 (10.1%) in the therapeutic heparin group and 38 (16.0%) in the prophylactic heparin group (odds ratio, 0.59; 95%-CI, 0.34 to 1.02). Major bleeding occurred in 2 patients (0.9%) with therapeutic heparin and 4 patients (1.7%) with prophylactic heparin (odds ratio, 0.52; 95%-CI, 0.09 to 2.85).

Conclusions: In moderately ill ward patients with Covid-19 and elevated D-dimer level, therapeutic heparin did not significantly reduce the primary outcome but decreased the odds of death at 28 days. Trial registration numbers: NCT04362085 ; NCT04444700.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1101/2021.07.08.21259351DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8282099PMC
July 2021

Correction: Convalescent Plasma for the Prevention and Treatment of COVID-19: A Systematic Review and Quantitative Analysis.

JMIR Public Health Surveill 2021 Jun 30;7(6):e31554. Epub 2021 Jun 30.

St. Michael's Hospital, Toronto, ON, Canada.

[This corrects the article DOI: 10.2196/25500.].
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/31554DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8280829PMC
June 2021

Severe upper gastrointestinal bleeding is halted by endoscopically delivered self-propelling thrombin powder: A porcine pilot study.

Endosc Int Open 2021 May 22;9(5):E693-E698. Epub 2021 Apr 22.

The University of British Columbia - Michael Smith Laboratories, Vancouver, British Columbia, Canada.

Hemostatic powders have emerged recently to treat upper gastrointestinal bleeding (UGIB). Previously, we developed a novel self-propelling thrombin powder (SPTP) that effectively manages external pulsatile arterial bleed without compression, by effervescing and carrying thrombin into the wound. Here, we tested if SPTP, sprayed endoscopically, can manage severe UGIB in a live porcine model. Anesthetized pigs underwent laparotomy to insert the gastroepiploic vascular bundles into the stomach lumen via a gastrotomy. Bleeding was initiated endoscopically in the stomach by needle knife. SPTP was delivered to the site of bleeding from a CO -powered spray device using a 7 FR catheter. Successful primary hemostasis, time to hemostasis, and the mass of SPTP delivered were measured. Hemostasis was achieved at all bleeding sites using SPTP. Mean time to hemostasis was 4.2 ± 0.9 minutes (mean ± standard error of the mean, n = 12). The average mass of SPTP delivered was 2.4 ± 0.6 g. In this pilot study, SPTP successfully stopped 12 cases of severe UGIB, demonstrating early promise asa novel hemostatic powder.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/a-1374-5839DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8062227PMC
May 2021

Convalescent Plasma for the Prevention and Treatment of COVID-19: A Systematic Review and Quantitative Analysis.

JMIR Public Health Surveill 2021 04 7;7(4):e25500. Epub 2021 Apr 7.

St. Michael's Hospital, Toronto, ON, Canada.

Background: The COVID-19 pandemic, caused by a novel coronavirus termed SARS-CoV-2, has spread quickly worldwide. Convalescent plasma (CP) obtained from patients following recovery from COVID-19 infection and development of antibodies against the virus is an attractive option for either prophylactic or therapeutic treatment, since antibodies may have direct or indirect antiviral activities and immunotherapy has proven effective in principle and in many clinical reports.

Objective: We seek to characterize the latest advances and evidence in the use of CP for COVID-19 through a systematic review and quantitative analysis, identify knowledge gaps in this setting, and offer recommendations and directives for future research.

Methods: PubMed, Web of Science, and Embase were continuously searched for studies assessing the use of CP for COVID-19, including clinical studies, commentaries, reviews, guidelines or protocols, and in vitro testing of CP antibodies. The screening process and data extraction were performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Quality appraisal of all clinical studies was conducted using a universal tool independent of study designs. A meta-analysis of case-control and randomized controlled trials (RCTs) was conducted using a random-effects model.

Results: Substantial literature has been published covering various aspects of CP therapy for COVID-19. Of the references included in this review, a total of 243 eligible studies including 64 clinical studies, 79 commentary articles, 46 reviews, 19 guidance and protocols, and 35 in vitro testing of CP antibodies matched the criteria. Positive results have been mostly observed so far when using CP for the treatment of COVID-19. There were remarkable heterogeneities in the CP therapy with respect to patient demographics, donor antibody titers, and time and dose of CP administration. The studies assessing the safety of CP treatment reported low incidence of adverse events. Most clinical studies, in particular case reports and case series, had poor quality. Only 1 RCT was of high quality. Randomized and nonrandomized data were found in 2 and 11 studies, respectively, and were included for meta-analysis, suggesting that CP could reduce mortality and increase viral clearance. Despite promising pilot studies, the benefits of CP treatment can only be clearly established through carefully designed RCTs.

Conclusions: There is developing support for CP therapy, particularly for patients who are critically ill or mechanically ventilated and resistant to antivirals and supportive care. These studies provide important lessons that should inform the planning of well-designed RCTs to generate more robust knowledge for the efficacy of CP in patients with COVID-19. Future research is necessary to fill the knowledge gap regarding prevention and treatment for patients with COVID-19 with CP while other therapeutics are being developed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/25500DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245055PMC
April 2021

Coagulopathy of hospitalised COVID-19: A Pragmatic Randomised Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG - RAPID Trial): A structured summary of a study protocol for a randomised controlled trial.

Trials 2021 Mar 10;22(1):202. Epub 2021 Mar 10.

St. Michael's Hospital, Applied Health Research Centre, Li Ka Shing Knowledge Institute, University of Toronto, Toronto, Canada.

Objectives: To determine the effect of therapeutic anticoagulation, with low molecular weight heparin (LMWH) or unfractionated heparin (UFH, high dose nomogram), compared to standard care in hospitalized patients admitted for COVID-19 with an elevated D-dimer on the composite outcome of intensive care unit (ICU) admission, non-invasive positive pressure ventilation, invasive mechanical ventilation or death up to 28 days.

Trial Design: Open-label, parallel, 1:1, phase 3, 2-arm randomized controlled trial PARTICIPANTS: The study population includes hospitalized adults admitted for COVID-19 prior to the development of critical illness. Excluded individuals are those where the bleeding risk or risk of transfusion would generally be considered unacceptable, those already therapeutically anticoagulated and those who have already have any component of the primary composite outcome. Participants are recruited from hospital sites in Brazil, Canada, Ireland, Saudi Arabia, United Arab Emirates, and the United States of America. The inclusion criteria are: 1) Laboratory confirmed COVID-19 (diagnosis of SARS-CoV-2 via reverse transcriptase polymerase chain reaction as per the World Health Organization protocol or by nucleic acid based isothermal amplification) prior to hospital admission OR within first 5 days (i.e. 120 hours) after hospital admission; 2) Admitted to hospital for COVID-19; 3) One D-dimer value above the upper limit of normal (ULN) (within 5 days (i.e. 120 hours) of hospital admission) AND EITHER: a. D-Dimer ≥2 times ULN OR b. D-Dimer above ULN and Oxygen saturation ≤ 93% on room air; 4) > 18 years of age; 5) Informed consent from the patient (or legally authorized substitute decision maker). The exclusion criteria are: 1) pregnancy; 2) hemoglobin <80 g/L in the last 72 hours; 3) platelet count <50 x 10/L in the last 72 hours; 4) known fibrinogen <1.5 g/L (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation); 5) known INR >1.8 (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation); 6) patient already prescribed intermediate dosing of LMWH that cannot be changed (determination of what constitutes an intermediate dose is to be at the discretion of the treating clinician taking the local institutional thromboprophylaxis protocol for high risk patients into consideration); 7) patient already prescribed therapeutic anticoagulation at the time of screening [low or high dose nomogram UFH, LMWH, warfarin, direct oral anticoagulant (any dose of dabigatran, apixaban, rivaroxaban, edoxaban)]; 8) patient prescribed dual antiplatelet therapy, when one of the agents cannot be stopped safely; 9) known bleeding within the last 30 days requiring emergency room presentation or hospitalization; 10) known history of a bleeding disorder of an inherited or active acquired bleeding disorder; 11) known history of heparin-induced thrombocytopenia; 12) known allergy to UFH or LMWH; 13) admitted to the intensive care unit at the time of screening; 14) treated with non-invasive positive pressure ventilation or invasive mechanical ventilation at the time of screening; 15) Imminent death according to the judgement of the most responsible physician; 16) enrollment in another clinical trial of antithrombotic therapy involving hospitalized patients.

Intervention And Comparator: Intervention: Therapeutic dose of LMWH (dalteparin, enoxaparin, tinzaparin) or high dose nomogram of UFH. The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Comparator: Standard care [thromboprophylactic doses of LMWH (dalteparin, enoxaparin, tinzaparin, fondaparinux)] or UFH. Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is generally considered standard care.

Main Outcomes: The primary composite outcome of ICU admission, non-invasive positive pressure ventilation, invasive mechanical ventilation or death at 28 days. Secondary outcomes include (evaluated up to day 28): 1. All-cause death 2. Composite of ICU admission or all-cause death 3. Composite of mechanical ventilation or all-cause death 4. Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation; 5. Red blood cell transfusion (>1 unit); 6. Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate; 7. Renal replacement therapy; 8. Hospital-free days alive; 9. ICU-free days alive; 10. Ventilator-free days alive; 11. Organ support-free days alive; 12. Venous thromboembolism (defined as symptomatic or incidental, suspected or confirmed via diagnostic imaging and/or electrocardiogram where appropriate); 13. Arterial thromboembolism (defined as suspected or confirmed via diagnostic imaging and/or electrocardiogram where appropriate); 14. Heparin induced thrombocytopenia; 15. Trajectories of COVID-19 disease-related coagulation and inflammatory biomarkers.

Randomisation: Randomisation will be stratified by site and age (>65 versus ≤65 years) using a 1:1 computer-generated random allocation sequence with variable block sizes. Randomization will occur within the first 5 days (i.e. 120 hours) of participant hospital admission. However, it is recommended that randomization occurs as early as possible after hospital admission. Central randomization using an interactive web response system will ensure allocation concealment.

Blinding (masking): No blinding involved. This is an open-label trial.

Numbers To Be Randomised (sample Size): 462 patients (231 per group) are needed to detect a 15% risk difference, from 50% in the control group to 35% in the experimental group, with power of 90% at a two-sided alpha of 0.05.

Trial Status: Protocol Version Number 1.4. Recruitment began on May 11, 2020. Recruitment is expected to be completed March 2022. Recruitment is ongoing.

Trial Registration: ClinicalTrials.gov Identifier: NCT04362085 Date of Trial Registration: April 24, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-021-05076-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943934PMC
March 2021

Freeze-dried plasma for major trauma - Systematic review and meta-analysis.

J Trauma Acute Care Surg 2021 03;90(3):589-602

From the Department of Emergency Medicine (G.M., R.H.), The Ottawa Hospital, University of Ottawa, Ottawa, Canada; Department of Critical Care (M.W.K.), Liverpool Hospital, Sydney, Australia; Department of Surgery (D.P., H.T., A.N., L.T.d.L.), Sunnybrook Health Sciences Centre, University of Toronto; Toronto Research Centre (H.P.), Defence Research and Development Canada; Department of Laboratory Medicine and Molecular Diagnostics (J.C.), Sunnybrook Health Sciences Centre; Department of Laboratory Medicine and Pathobiology (J.C.), Department of Anesthesia and Pain Medicine (K.K.), University of Toronto, and Department of Surgery (A.B.), Saint Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Background: Treatment of acute trauma coagulopathy has shifted toward rapid replacement of coagulation factors with frozen plasma (FP). There are logistic difficulties in providing FP. Freeze-dried plasma (FDP) may have logistical advantages including easier storage and rapid preparation time. This review assesses the feasibility, efficacy, and safety of FDP in trauma.

Study Design And Methods: Studies were searched from Medline, Embase, Cochrane Controlled Trials Register, ClinicalTrials.gov, and Google Scholar. Observational and randomized controlled trials (RCTs) assessing FDP use in trauma were included. Trauma animal models addressing FDP use were also included. Bias was assessed using validated tools. Primary outcome was efficacy, and secondary outcomes were feasibility and safety. Meta-analyses were conducted using random-effect models. Evidence was graded using Grading of Recommendations Assessment, Development, and Evaluation profile.

Results: Twelve human studies (RCT, 1; observational, 11) and 15 animal studies were included. Overall, studies demonstrated moderate risk of bias. Data from two studies (n = 119) were combined for meta-analyses for mortality and transfusion of allogeneic blood products (ABPs). For both outcomes, no difference was identified. For mortality, pooled odds ratio was 0.66 (95% confidence interval, 0.29-1.49), with I2 = 0%. Use of FDP is feasible, and no adverse events were reported. Animal data suggest similar results for coagulation and anti-inflammatory profiles for FP and FDP.

Conclusion: Human data assessing FDP use in trauma report no difference in mortality and transfusion of ABPs in patients receiving FDP compared with FP. Data from animal trauma studies report no difference in coagulation factor and anti-inflammatory profiles between FP and FDP. Results should be interpreted with caution because most studies were observational and have heterogeneous population (military and civilian trauma) and a moderate risk of bias. Well-designed prospective observational studies or, preferentially, RCTs are warranted to answer FDP's effect on laboratory (coagulation factor levels), transfusion (number of ABPs), and clinical outcomes (organ dysfunction, length of stay, and mortality).

Level Of Evidence: Systematic review and meta-analysis, level IV.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/TA.0000000000003012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899224PMC
March 2021

Feasibility of intraoperative angioembolization for trauma patients using C-arm digital subtraction angiography.

Eur J Trauma Emerg Surg 2021 Jan 5. Epub 2021 Jan 5.

Division of Trauma and General Surgery, McGill University Health Centre, Montreal General Hospital Site, 1650 Cedar Ave Room L9-421, Montreal, QC, H3G 1A4, Canada.

Purpose: Hemodynamically unstable trauma patients who would benefit from angioembolization (AE) typically also require emergent surgery for their injuries. The critical decision of transferring a patient to the operating room versus the interventional radiology (IR) suite can be bypassed with the advent of intra-operative AE (IOAE). Previously limited by the availability of costly rooms termed RAPTOR (resuscitation with angiography, percutaneous techniques and open repair) suites, it has been suggested that using C-arm digital subtraction angiography (DSA) is a comparable alternative. This case series aims to establish the feasibility and safety of IOAE.

Methods: We conducted a retrospective analysis of all trauma patients at our level 1 trauma center who underwent IOAE with a concomitant surgical intervention from January 2011 to May 2019. Descriptive analyses were conducted.

Results: A total of 49 patients (80% male, 44 ± 17 years, 92% blunt) underwent IOAE using the C-arm DSA during the study period. All but one patient underwent exploratory laparotomy, 56% of which underwent an additional surgical procedure (ex. exploratory thoracotomy, orthopedic). Either Gelfoam (Pfizer, New York, USA) (90%), coils (2.0%), or a combination (8.2%) were used for embolization. Internal iliac embolization was performed in 88% of cases (59% bilateral). IOAE was successful in all but four cases (8.2%) and thirty-day mortality was 31%.

Conclusion: IOAE appears to be a feasible and safe management option in severe trauma patients with the advantage of concurrent operative intervention and ongoing active resuscitation with good success in hemorrhage control.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00068-020-01530-xDOI Listing
January 2021

Stability of Reconstituted Fibrinogen Concentrate in Hemostatic Function and Concentration.

Mil Med 2021 02;186(3-4):286-292

The Department of National Defence, McGill University, Montreal, Quebec H3Z 2G5, Canada.

Introduction: Canadian Armed Forces adopted fibrinogen concentrate (RiaSTAP) for hemostatic resuscitation in the far-forward combat setting, given its potential benefits of reducing blood loss, blood transfusion and mortality, and its long storage stability and high portability. The current guidance recommends that RiaSTAP should be administered within 8 hours after reconstitution when stored at room temperature. However, little information about its stability is available. There is also a need to investigate the stability and efficacy of RiaSTAP after reconstitution and exposure to extreme temperatures in which our forces may operate.

Materials And Methods: RiaSTAP was reconstituted as per manufacturer's instruction and stored at specific temperatures (-20°C, 4°C, 22°C, 35°C, 42°C, or 50°C) for up to 6 months. Reconstituted RiaSTAP was also oscillated on a rocker at 18 rpm under 22°C and 50°C. Its hemostatic function was measured using rotational thromboelastometry performed with RiaSTAP-spiked whole blood. Fibrinogen concentrations were measured by a commercial enzyme-linked immunosorbent assay (ELISA) kit. Gel electrophoresis was also conducted for initial and stored samples.

Results: We found no change to the hemostatic function of reconstituted RiaSTAP after storage at -20°C for 6 months. At 4°C, no obvious changes to the hemostatic effect of reconstituted RiaSTAP relative to 0 hours were seen until 1,680 hours. At 22°C, a remarkable decrease began after storage for 168 hours. Storage at 35°C significantly decreased the hemostatic effect after 144 hours, while the storage at 42°C resulted in decreased hemostatic function after 72 hours. Finally, storage at 50°C for 8 hours resulted in complete loss of hemostatic function. Compared to the hemostatic activity, the fibrinogen concentration for reconstituted RiaSTAP showed less change over time. No apparent decline in fibrinogen concentration was seen after storage at -20°C for 6 months and at 4°C for 1,680 hours. At 22°C, there were no clear alterations until 792 hours. There was a decline in fibrinogen concentration at 35°C and 42°C after 672 and 600 hours of storage, respectively. At 50°C, little amount of fibrinogen was detected by ELISA at 8 hours. Similar changes in the hemostatic effect and fibrinogen concentration over time were observed under the rocking condition in comparison with the static condition at the same temperature. The gel electrophoresis confirmed fibrinogen degradation which increased with storage temperature and time.

Conclusions: The stability of reconstituted RiaSTAP decreases with increasing storage temperature. The hemostatic function deteriorated before fibrinogen concentration and integrity were significantly altered at all temperatures for the study period except at 50°C where there was a rapid decline in both hemostatic function and fibrinogen concentration. Sample oscillation did not significantly affect its stability. The shelf life of reconstituted RiaSTAP may, therefore, be recommended accordingly when stored at different temperatures and extended to 6 days at room temperature provided that sterility is maintained.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/milmed/usaa409DOI Listing
February 2021

Primary aeromedical retrieval crew composition: Do different teams impact clinical outcomes? A descriptive systematic review.

CJEM 2020 09;22(S2):S89-S103

Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON.

Objectives: Military Forward Aeromedical Evacuation and civilian Helicopter Emergency Medical Services are widely used to conduct Primary Aeromedical Retrieval. Crew composition in Primary Aeromedical Retrieval missions varies considerably. The ideal composition is unknown. Thus, we conducted a descriptive systematic review on mortality and other outcomes for different Primary Aeromedical Retrieval crew compositions.

Methods: Medline, Embase, and Cochrane Controlled Trials Register were searched up to January 2020. Results were reported per Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Studies of adult trauma air transported by different crews were included. Population, injury severity, crew composition, procedures, and outcomes, including mortality, were abstracted. Risk of bias was assessed using previously validated tools. A lack of reported effect measures precluded a quantitative analysis.

Results: Sixteen studies met inclusion criteria (3 prospective studies, 1 case-control, and 12 retrospective). Overall, studies reported a mortality benefit associated with advanced health care providers. This was most apparent in patients with severe but survivable injuries. In this population, early rapid sequence induction, endotracheal intubation, mechanical ventilation, thoracostomies, blood products transfusion, and treatment of hemorrhagic shock are better performed by advanced providers and may improve outcomes. The quality of evidence reported a moderate risk of bias in the included studies.

Conclusions: Overall, findings were divergent but showed a trend to decreased mortality in patients treated by advanced providers with interventions beyond the basic paramedic level. This trend was most significant in patients with severe but survivable injuries. These results should be cautiously interpreted because most studies were observational, had small sample sizes, and had a high potential for confounding factors.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1017/cem.2020.404DOI Listing
September 2020

Intermittent use of resuscitative endovascular balloon occlusion of the aorta in penetrating gunshot wound of the lower extremity

Can J Surg 2019 12 1;62(6):E9-E12. Epub 2019 Dec 1.

From the Trauma Program, McGill University Health Centre, Montreal, Que. (Beckett, Bekdache, Bracco, Elbahrawy, Khwaja, Deckelbaum, Fata, Razek, Grushka); the Faculty of Medicine, McGill University, Montreal, Que. (Paradis); the Medical Research Institute, Alexandria University, Alexandria, Egypt (Elbahrawy); and the Royal Canadian Medical Services, Montreal, Que. (Beckett).

Summary: The use of resuscitative endovascular balloon occlusion of the aorta (REBOA) in penetrating injuries is an emerging adjunct in the civilian trauma surgeon’s toolbox for the management of traumatic hemorrhagic shock. Furthermore, within the Canadian civilian context, little has been reported with regard to its use as an assisted damage-control measure in vascular reconstruction of the lower extremity. We report a case of penetrating gunshot injury of the lower extremity where the preoperative deployment of REBOA had a remarkable positive impact in the resuscitation phase and the intraoperative control of blood loss. A description of the procedure and the advantage gained from REBOA are discussed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1503/cjs.017018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6877395PMC
December 2019

The Financial Burden of Road Traffic Injuries in Mozambique: A Hospital-Related Cost-of-Illness Study of Maputo Central Hospital.

World J Surg 2019 12;43(12):2959-2966

Department of Surgery, Maputo Central Hospital, Maputo, Mozambique.

Background: Road traffic injuries (RTIs) are increasingly being recognized for their significant economic impact. Mozambique, like other low-income countries, suffers staggering rates of road traffic collisions. To our knowledge, this is the first study to estimate direct hospital costs of RTIs using a bottom-up, micro-costing approach in the Mozambican context. This study aims to calculate the direct, inpatient costs of RTIs in Mozambique and compare it to the financial capacity of the Mozambican public health care system.

Methods: This was a retrospective, single-centre study. Charts of all patients with RTIs admitted to Maputo Central Hospital over a period of 2 months were reviewed. The costs were recorded and analysed based on direct costs, human resource costs, and overhead costs. Costs were calculated using a micro-costing approach.

Results: In total, 114 patients were admitted and treated for RTIs at Maputo Central Hospital during June-July 2015. On average, the hospital cost per patient was US$ 604.28 (IQR 1033.58). Of this, 44% was related to procedural costs, 23% to diagnostic imaging costs, 17% to length-of-stay costs, 9% to medication costs, and 7% to laboratory test costs. The average annual inpatient cost of RTIs in Mozambique was almost US$ 116 million (0.8% of GDP).

Conclusion: The financial burden of RTIs in Mozambique represents approximately 40% of the annual public health care budget. These results help highlight the economic impact of trauma in Mozambique and the importance of an organized trauma system to reduce such costs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00268-019-05152-2DOI Listing
December 2019

Management of Open Abdomen After Trauma Laparotomy: A Comparative Analysis of Dynamic Fascial Traction and Negative Pressure Wound Therapy Systems.

World J Surg 2019 12;43(12):3044-3050

Division of Trauma Surgery, McGill University Health Centre, McGill University, 1650 Cedar Avenue, L9-411, Montreal, QC, H3G 1A4, Canada.

Background: Management of the post-traumatic open abdomen (OA) using negative pressure wound therapy (NPWT) alone is associated with low rates of primary fascial closure. The abdominal reapproximation anchor (ABRA) system exerts dynamic medial fascial traction and may work synergistically with NPWT to facilitate primary fascial closure.

Methods: Patients with an OA following trauma laparotomy between 2009 and 2018 were identified from a prospectively maintained institutional database. Patients treated with ABRA in conjunction with NPWT (ABRA) versus NPWT alone (NPWT) were compared in terms of primary fascial closure rate, number of surgeries to closure, tracheostomy duration, length of stay and incidence of entero-atmospheric fistula. Multivariable linear regression was performed to identify predictors of tracheostomy duration.

Results: We identified 48 patients [ABRA, 12 and NPWT, 36]. The ABRA group was significantly younger (25 vs. 37 years, p = 0.027) and included a lower proportion of males (58% vs. 89%, p = 0.032). Groups were similar with respect to the incidence of hollow viscus injury, injury severity score and abdominal abbreviated injury score. Compared to the NPWT group, the ABRA group had a significantly higher rate of primary fascial closure (100% vs. 28%, p < 0.001), fewer surgeries to abdominal closure (2 vs. 2.5, p = 0.023) and shorter duration of tracheostomy (15.5 vs. 36 days, p = 0.008). There were no differences in length of stay or incidence of entero-atmospheric fistula. On multivariable linear regression, ABRA placement was an independent predictor of shorter tracheostomy duration, after adjusting for covariates (β = - 0.294, p = 0.036).

Conclusion: For the post-traumatic OA, ABRA coupled with NPWT achieves a higher rate of primary fascial closure compared to NPWT alone, while requiring fewer surgeries and a shorter duration of tracheostomy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00268-019-05166-wDOI Listing
December 2019

A regional massive hemorrhage protocol developed through a modified Delphi technique.

CMAJ Open 2019 Jul-Sep;7(3):E546-E561. Epub 2019 Sep 3.

Departments of Laboratory Medicine and Molecular Diagnostics (Callum, Chin, Viveiros), Surgery (Nathens, Nascimento), Emergency Services (McDonald), Critical Care Medicine (Adhikari) and Anesthesia (Margarido), Sunnybrook Health Sciences Centre; Departments of Laboratory Medicine and Pathobiology (Callum, Pendergrast, Skeate, Pavenski), Anesthesia (McVey, Karkouti, Alam, Margarido), Surgery (Nathens, Nascimento, Rizoli) and Paediatrics (Beno), University of Toronto; Division of Emergency Medicine (Yeh, Petrosoniak, McDonald, MacDonald), Department of Medicine, University of Toronto; Departments of Emergency Medicine (Petrosoniak), Surgery (Rizoli) and Laboratory Medicine (Sholzberg, Pavenski), St. Michael's Hospital; Department of Anesthesia and Pain Medicine (McVey, Skelton), The Hospital for Sick Children; Ontario Regional Blood Coordinating Network (Cope, Thompson, Collins, Owens); Department of Anesthesia and Pain Management (Karkouti), Sinai Health System, University Health Network, and Women's College Hospital, Toronto, Ont.; Department of Anesthesiology and Pain Medicine (Murto), Children's Hospital of Eastern Ontario; Department of Anesthesiology and Pain Medicine (Murto), University of Ottawa, Ottawa, Ont.; Paediatric Emergency Medicine (Beno), The Hospital for Sick Children; Department of Clinical Pathology (Pendergrast), University Health Network, Toronto, Ont.; Ornge Transport Medicine (McDonald, MacDonald), Mississauga, Ont.; Interdepartmental Division of Critical Care Medicine (Adhikari), University of Toronto; Department of Anesthesia (Alam, Arnold), North York General Hospital, Toronto, Ont.; McMaster Centre for Transfusion Research (Arnold, Pai, Zeller); Departments of Medicine (Pai, Zeller) and Pathology and Molecular Medicine (Pai), McMaster University, Hamilton, Ont.; Canadian Blood Services (Arnold, Skeate, White); St. Michael's Hospital (Barratt, Chaudhry, Harvey), Toronto, Ont.; Department of Surgery (Beckett), McGill University, Montréal, Que.; Canadian Forces Health Services (Beckett), Ottawa, Ont.; Sunnybrook Health Sciences Centre (Brenneman), Toronto, Ont.; General Surgery, Acute Care and Trauma (Lampron), The Ottawa Hospital; Departments of Surgery (Lampron), Medicine (Tinmouth) and Laboratory Medicine and Pathology (Tinmouth), Faculty of Medicine, University of Ottawa, Ottawa, Ont.; Trauma Program and Quality Assurance (McFarlan), St. Michael's Hospital, Toronto, Ont.; Departments of Pathology (Ruijs) and Surgery (Van Heest), William Osler Health Centre, Brampton, Ont.; Lakeridge Health Corporation (Syer), Oshawa, Ont.; Department of Critical Care (Theriault), Health Sciences North, Sudbury, Ont.; Division of Hematology (Tinmouth), The Ottawa Hospital; University of Ottawa Centre for Transfusion Research (Tinmouth), Ottawa Hospital Research Institute, Ottawa, Ont.; Canadian Blood Services (Zeller), Ancaster, Ont.

Background: A massive hemorrhage protocol (MHP) enables rapid delivery of blood components in a patient who is exsanguinating pending definitive hemorrhage control, but there is variability in MHP implementation rates, content and compliance owing to challenges presented by infrequent activation, variable team performance and patient acuity. The goal of this project was to identify the key evidence-based principles and quality indicators required to develop a standardized regional MHP.

Methods: A modified Delphi consensus technique was performed in the spring and summer of 2018. Panellists used survey links to independently review and rate (on a 7-point Likert scale) 43 statements and 8 quality indicators drafted by a steering committee composed of transfusion medicine specialists and technologists, and trauma physicians. External stakeholder input from all hospitals in Ontario was sought.

Results: Three rounds were held with 36 experts from diverse clinical backgrounds. Consensus was reached for 42 statements and 8 quality indicators. Additional modifications from external stakeholders were incorporated to form the foundation for the proposed MHP.

Interpretation: This MHP template will provide the basis for the design of an MHP toolkit, including specific recommendations for pediatric and obstetrical patients, and for hospitals with limited availability of blood components or means to achieve definitive hemorrhage control. We believe that harmonization of MHPs in our region will simplify training, increase uptake of evidence-based interventions, enhance communication, improve patient comfort and safety, and, ultimately, improve patient outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.9778/cmajo.20190042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6726467PMC
September 2019

Resuscitative endovascular balloon occlusion of the aorta (REBOA): indications: advantages and challenges of implementation in traumatic non-compressible torso hemorrhage.

Trauma Surg Acute Care Open 2019 15;4(1):e000262. Epub 2019 Apr 15.

Department of Trauma and Acute Care Surgery, McGill University Health Centre, Montreal, Quebec, Canada.

Background: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is regaining popularity in the treatment of traumatic non-compressible torso bleeding. Advances in invasive radiology coupled with new damage control measures assisted in the refinement of the technique with promising outcomes. The literature continues to have substantial heterogeneity about REBOA indications, applications, and the challenges confronted when implementing the technique in a level I trauma center. Scoping reviews are excellent platforms to assess the diverse literature of a new technique. It is for the first time that a scoping review is adopted for this topic. Advances in invasive radiology coupled with new damage control measures assisted in the refinement of the technique with promising outcomes. The literature continues to have substantial heterogeneity about REBOA indications, applications, and the challenges confronted when implementing the technique in a level I trauma center. Scoping reviews are excellent platforms to assess the diverse literature of a new technique. It is for the first time that a scoping review is adopted for this topic.

Methods: Critical search from MEDLINE, EMBASE, BIOSIS, COCHRANE CENTRAL, PUBMED and SCOPUS were conducted from the earliest available dates until March 2018. Evidence-based articles, as well as gray literature at large, were analyzed regardless of the quality of articles.

Results: We identified 1176 articles related to the topic from all available database sources and 57 reviews from the gray literature search. The final review yielded 105 articles. Quantitative and qualitative variables included patient demographics, study design, study objectives, methods of data collection, indications, REBOA protocol used, time to deployment, zone of deployment, occlusion time, complications, outcome, and the level of expertise at the concerned trauma center.

Conclusion: Growing levels of evidence support the use of REBOA in selected indications. Our data analysis showed an advantage for its use in terms of morbidities and physiologic derangement in comparison to other resuscitation measures. Current challenges remain in the selective application, implementation, competency assessment, and credentialing for the use of REBOA in trauma settings. The identification of the proper indication, terms of use, and possible advantage of the prehospital and partial REBOA are topics for further research.

Level Of Evidence: Level III.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/tsaco-2018-000262DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6560484PMC
April 2019

A comparative study of viscoelastic hemostatic assays and conventional coagulation tests in trauma patients receiving fibrinogen concentrate.

Clin Chim Acta 2019 Aug 17;495:253-262. Epub 2019 Apr 17.

Royal Canadian Medical Services, Ottawa, ON, Canada; McGill University, Montreal, QC, Canada.

Background: Both thrombelastography (TEG) and rotational thromboelastometry (ROTEM) have been investigated for diagnosis of coagulopathy and guidance of resuscitation in trauma and surgery. Given similarities between the two systems, it is important to determine whether one is superior to the other and how comparable they are to conventional coagulation tests (CCTs). Therefore, we conducted a comparative study of functional fibrinogen and coagulation assays using TEG and ROTEM and CCTs to determine their capability to monitor coagulation profiles, diagnose coagulopathy and predict blood transfusion requirements in trauma patients.

Methods: Blood samples were collected from 45 patients at admission and during 48-h hospitalization as part of a randomized control trial on early fibrinogen replacement in trauma. Functional fibrinogen (FF) TEG, ROTEM FIBTEM and EXTEM, and CCTs were performed and compared.

Results: We found significant differences between the placebo and fibrinogen groups over hospitalization time in FF TEG MA, ROTEM CT, MCF and LI30. FF TEG MA and ROTEM FIBTEM MCF mirrored plasma fibrinogen profiles, reached a maximum difference between the two groups 1-3 h after fibrinogen administration. In comparison, CCTs detected minimal hemostatic changes by fibrinogen treatment. TEG and ROTEM showed various degrees of correlations with CCTs. TEG MA and ROTEM MCF provided better predictions for plasma and RBC transfusions than CCTs, but poor accuracy for cryoprecipitate transfusion. Both TEG and ROTEM well predicted hypofibrinogenemia (fibrinogen concentration < 1 g/L), but poorly detected coagulopathy (INR ≥ 1.2).

Conclusions: TEG and ROTEM detected increases in clot strength following early use of fibrinogen. ROTEM also detected changes in coagulation time and clot lysis. Both were better than CCTs for monitoring coagulation profiles and predicting transfusion requirements.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cca.2019.04.066DOI Listing
August 2019

Perioperative Mortality Rates as a Health Metric for Acute Abdominal Surgery in Low- and Middle-Income Countries: A Systematic Review and Future Recommendations.

World J Surg 2019 08;43(8):1880-1889

Department of Trauma and Acute Surgical Care, McGill University Health Centre, Montreal, Canada.

Background: Approximately 5 billion people do not have access to safe, timely, and affordable surgical and anesthesia care, with this number disproportionately affecting those from low-middle-income countries (LMICs). Perioperative mortality rates (POMRs) have been identified by the World Health Organization as a potential health metric to monitor quality of surgical care provided. The purpose of this systematic review was to evaluate published reports of POMR and suggest recommendations for its appropriate use as a health metric.

Methods: The protocol was registered a priori with PROSPERO. A peer-reviewed search strategy was developed adhering with the PRISMA guidelines. Relevant articles were identified through Medline, Embase, CENTRAL, CDSR, LILACS, PubMed, BIOSIS, Global Health, Africa-Wide Information, Scopus, and Web of Science databases. Two independent reviewers performed a primary screening analysis based on titles and abstracts, followed by a full-text screen. Studies describing POMRs of adult emergency abdominal surgeries in LMICs were included.

Results: A total of 7787 articles were screened of which 7466 were excluded based on title and abstract. Three hundred and twenty-one articles entered full-text screen of which 70 articles met the inclusion criteria. Variables including timing of POMR reporting, intraoperative mortality, length of hospital stay, complication rates, and disease severity score were collected. Complication rates were reported in 83% of studies and postoperative stay in 46% of studies. 40% of papers did not report the specific timing of POMR collection. 7% of papers reported on intraoperative death. Additionally, 46% of papers used a POMR timing specific to the duration of their study. Vital signs were discussed in 24% of articles, with disease severity score only mentioned in 20% of studies.

Conclusion: POMR is an important health metric for quantifications of quality of care of surgical systems. Further validation and standardization are necessary to effectively use this health metric.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00268-019-04993-1DOI Listing
August 2019

Deployment of second-generation resuscitative endovascular balloon occlusion of the aorta for unresponsive hypotension in a polytrauma patient

Can J Surg 2019 04;62(2):142-144

From the Faculty of Medicine McGill University, Montreal, Que. (Paradis); the Trauma Program, McGill University Health Centre, Montreal, Que, (Bekdache, Bracco, Grushka, Razek, Lasry, Beckett); and the Royal Canadian Medical Services, Montreal, Que. (Beckett).

Summary: Noncompressible hemorrhagic control remains one of the most challenging areas in damage control medicine and continues to be a leading cause of preventable death. For decades, emergency thoracotomy or laparotomy and aortic cross clamping have remained the gold standard intervention. Recently, there has been a movement toward less invasive techniques for noncompressible hemorrhagic control, such as resuscitative endovascular balloon occlusion of the aorta (REBOA). The REBOA technique involves inflation of an endovascular balloon within the abdominal aorta proximal to the vascular injury to temporarily inhibit bleeding. Although the literature is robust on this new technique, skepticism remains about whether REBOA is superior to aortic cross clamping, as it has been associated with complications including organ and limb ischemia, limb amputation, femoral aneurysm, and thrombosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1503/cjs.007618DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6440891PMC
April 2019

Resuscitative endovascular balloon occlusion of the aorta (REBOA): a scoping review protocol concerning indications-advantages and challenges of implementation in traumatic non-compressible torso haemorrhage.

BMJ Open 2019 02 19;9(2):e027572. Epub 2019 Feb 19.

Department of Trauma and Acute Surgical Care, McGill University Health Centre, Montreal, Quebec, Canada.

Introduction: Haemorrhage remains the leading cause of preventable death in trauma. Damage control measures applied to patients in extremis in order to control exsanguinating bleeding from non-compressible torso injuries use different techniques to limit blood flow from the aorta to the rest of the body. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is regaining momentum recently as an adjunct measure that can provide the same results using less invasive approaches. This scoping review aims to provide a comprehensive understanding of the existing literature on REBOA. The objective is to analyse evidence and non-evidence-based medical reports and to describe current gaps in the literature about the best indication and implementation strategies for REBOA.

Methods And Analysis: Using the five-stage framework of Arksey and O'Malley's scoping review methodology as a guide, we will perform a systematic search in the following databases: MEDLINE, EMBASE, BIOSIS, COCHRANE CENTRAL, PUBMED and SCOPUS from the earliest available publications. The aim is to identify diverse studies related to the topic of REBOA. For a comprehensive search, we will explore organisational websites, key journals and hand-search reference lists of key studies. Data will be charted and sorted using a descriptive analytical approach.

Ethics And Dissemination: Ethics approval is not necessary as the data are collected from publicly available sources and there will be no consultative phase. The results will be disseminated through presentations at local, national, clinical and medical education conferences and through publication in a peer-reviewed journal.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2018-027572DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6368000PMC
February 2019

Thromboelastography and Thromboelastometry in Assessment of Fibrinogen Deficiency and Prediction for Transfusion Requirement: A Descriptive Review.

Biomed Res Int 2018 25;2018:7020539. Epub 2018 Nov 25.

Royal Canadian Medical Services, Ottawa, Ontario, and McGill University, Montreal, Quebec, Canada.

Fibrinogen is crucial for the formation of blood clot and clinical outcomes in major bleeding. Both Thromboelastography (TEG) and Rotational Thromboelastometry (ROTEM) have been increasingly used to diagnose fibrinogen deficiency and guide fibrinogen transfusion in trauma and surgical bleeding patients. We conducted a comprehensive and comparative review on the technologies and clinical applications of two typical functional fibrinogen assays using TEG (FF TEG) and ROTEM (FIBTEM) for assessment of fibrinogen level and deficiency, and prediction of transfusion requirement. Clot strength and firmness of FF TEG and ROTEM FIBTEM were the most used parameters, and their associations with fibrinogen levels as measured by Clauss method ranged from 0 to 0.9 for FF TEG and 0.27 to 0.94 for FIBTEM. A comparison of the interchangeability and clinical performance of the functional fibrinogen assays using the two systems showed that the results were correlated, but are not interchangeable between the two systems. It appears that ROTEM FIBTEM showed better associations with the Clauss method and more clinical use for monitoring fibrinogen deficiency and predicting transfusion requirements including fibrinogen replacement than FF TEG. TEG and ROTEM functional fibrinogen tests play important roles in the diagnosis of fibrinogen-related coagulopathy and guidance of transfusion requirements. Despite the fact that high-quality evidence is still needed, the two systems are likely to remain popular for the hemostatic management of bleeding patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1155/2018/7020539DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6286766PMC
April 2019

The effectiveness of junctional tourniquets: A systematic review and meta-analysis.

J Trauma Acute Care Surg 2019 03;86(3):532-539

From the Royal Canadian Medical Service (S.S., J.W., A.B., V.C.M., R.H.), Ottawa; Department of Surgery (S.S., J.W., V.C.M., R.H.), University of Western Ontario, London, ON; Department of Surgery (A.B.), McGill University, Montreal, QC, Canada; and Department of Epidemiology (K.N.W.), Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

Background: Junctional tourniquets have been incorporated into tactical combat casualty care for junctional vascular trauma. They apply external compression to stop blood flow in the groin and axilla.

Objectives: The primary outcome was effectiveness in achieving arterial occlusion. Secondary outcomes included time to application and pain scores.

Data Sources: Medline and EMBASE databases were searched.

Study Appraisal And Synthesis Methods: A random-effects meta-analysis was conducted to estimate the average effectiveness and time to effective application for each device.

Results: Eight studies reported the effectiveness of junctional tourniquets in healthy volunteers. The average effectiveness was 52% (95% confidence interval [CI], 15-87%) for the abdominal application of the abdominal aortic and junctional tourniquet (AAJT), 83% (95% CI, 73-89%; 26%) for the junctional Emergency Treatment Tool, 87% (95% CI, 79-92%; 15%) for the SAM junctional tourniquet (SJT), and 95% (95% CI, 90-98%) for the Combat Ready Clamp. The groin application of the AAJT was studied in two articles with 100% in both studies. The average time to application was 101 seconds for the SAM junctional tourniquet (95% CI, 50-152 seconds) and the Combat Ready Clamp (95% CI, 63-139 seconds), while it was 130 seconds (95% CI, 85-176 seconds) for the Junctional Emergency Treatment Tool. The abdominal application of AAJT had an average time to application of 92 and 171 seconds in two studies.

Limitations: All studies were conducted in healthy volunteers.

Conclusion And Implications: Junctional tourniquets may meet a medical need in combat, and in the civilian environment, to control hemorrhage from these difficult injuries. All four Food and Drug Administration-approved devices demonstrate the ability to achieve vascular occlusion in healthy volunteers; however, effectiveness in patient transport has not been evaluated, and outcomes of their use in the field need to be captured and reported.

Level Of Evidence: Systematic review, level III.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/TA.0000000000002159DOI Listing
March 2019

After the war is over: the role of General Sir Arthur Currie in the development of academic medicine in Canada

Can J Surg 2018 12;61(6):367-369

From Western University, London, Ont. (Hyatt, McAlister); McGill University, Montreal, Que. (Beckett); and the Royal Canadian Medical Services, (Beckett, McAlister).

Summary: Canadian universities faced a challenge with the return of a large cohort of battle-hardened students and faculty from the First World War. General Sir Arthur Currie, considered one of the few successful generals of the war, returned to a welcome of silence in Canada. McGill University exploited the opportunity to recruit him as its president. Currie oversaw a campaign of building construction and faculty development at McGill that also had a significant effect on the rest of Canada. Through his fostering of the Montreal Neurological Institute and the recruitment of Dr. Wilder Penfield, Currie facilitated the development of multidisciplinary medicine, which integrates clinical care with research — an aspiration still held by specialty medicine in Canada today.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1503/cjs.017118DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6281458PMC
December 2018

Damage Control Resuscitation.

Mil Med 2018 09;183(suppl_2):36-43

Joint Trauma System, 3698 Chambers Pass, Joint Base San Antonio, Fort Sam Houston, TX.

Damage control resuscitation (DCR) is a strategy for resuscitating patients from hemorrhagic shock to rapidly restore homeostasis. Efforts are focused on blood product transfusion with whole blood or component therapy closely approximating whole blood, limited use of crystalloid to avoid dilutional coagulopathy, hypotensive resuscitation until bleeding control is achieved, empiric use of tranexamic acid, prevention of acidosis and hypothermia, and rapid definitive surgical control of bleeding. Patients receiving uncrossmatched Type O blood in the emergency department and later receiving cumulative transfusions of 10 or more red blood cell units in the initial 24-hour post-injury (massive transfusion) are widely recognized as being at increased risk of morbidity and mortality due to exsanguination. Ideally, these patients should be rapidly identified, however anticipating transfusion needs is challenging. Useful indicators of massive transfusion reviewed in this guideline include: systolic blood pressure <110 mmHg, heart rate > 105 bpm, hematocrit <32%, pH < 7.25, injury pattern (above-the-knee traumatic amputation especially if pelvic injury is present, multi-amputation, clinically obvious penetrating injury to chest or abdomen), >2 regions positive on Focused Assessment with Sonography for Trauma (FAST) scan, lactate concentration on admission >2.5, admission international normalized ratio ≥1.2-1.4, near infrared spectroscopy-derived StO2 < 75% (in practice, rarely available), BD > 6 meq/L. Unique aspects of out-of-hospital DCR (point of injury, en-route, and remote DCR) and in-hospital (Medical Treatment Facilities: Role 2b/Forward surgical teams - role 3/ combat support hospitals) are reviewed in this guideline, along with pediatric considerations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/milmed/usy112DOI Listing
September 2018

Whole Blood Transfusion.

Mil Med 2018 09;183(suppl_2):44-51

Joint Trauma System, 3698 Chambers Pass, Joint Base San Antonio, Fort Sam Houston, TX.

Whole blood is the preferred product for resuscitation of severe traumatic hemorrhage. It contains all the elements of blood that are necessary for oxygen delivery and hemostasis, in nearly physiologic ratios and concentrations. Group O whole blood that contains low titers of anti-A and anti-B antibodies (low titer group O whole blood) can be safely transfused as a universal blood product to patients of unknown blood group, facilitating rapid treatment of exsanguinating patients. Whole blood can be stored under refrigeration for up to 35 days, during which it retains acceptable hemostatic function, though supplementation with specific blood components, coagulation factors or other adjuncts may be necessary in some patients. Fresh whole blood can be collected from pre-screened donors in a walking blood bank to provide effective resuscitation when fully tested stored whole blood or blood components are unavailable and the need for transfusion is urgent. Available clinical data suggest that whole blood is at least equivalent if not superior to component therapy in the resuscitation of life-threatening hemorrhage. Low titer group O whole blood can be considered the standard of care in resuscitation of major hemorrhage.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/milmed/usy120DOI Listing
September 2018

Trauma Hemostasis and Oxygenation Research Network position paper on the role of hypotensive resuscitation as part of remote damage control resuscitation.

J Trauma Acute Care Surg 2018 06;84(6S Suppl 1):S3-S13

From the Academic Department of Military Anaesthetics and Critical Care (T.W.), Royal Centre for Defence Medicine, Birmingham, United Kingdom; UK Paramedic (P.T.), THOR Steering Committee, Scotland; Combat Casualty Care (E.K.), Medical & Trauma Sciences, Defence Science and Technology Laboratory, Wiltshire; 16 Medical Regiment (R.R.), Colchester, United Kingdom; Anaesthesia and Intensive Care (S.A.), Val de Grâce Military Academy, Paris, France; Royal Canadian Medical Services (A.B.), McGill University, Montreal, Canada; Department of Anaesthesia and Intensive Care (C.B.), Haukeland University Hospital, Bergen, Norway; Coagulation and Blood Research (A.C.), US Army Institute of Surgical Research, San Antonio, Texas; Emergency Medicine (T.C.), University of Leicester, Leicester, United Kingdom; Surgery (M.C.), University of Colorado School of Medicine, Aurora; Paramedic NREMT (M.D.); Trauma/Acute Care Surgery (W.D.), University of Colorado Health, Denver, Colorado; Transfusion Medicine (H.D.), NHS Blood and Transplant, Watford, United Kingdom; Chief Quality Officer (R.D.); Department of Surgery (B.E.), UT Health Science Center, San Antonio, Texas; Israel Defense Forces Medical Corps. (E.G.), Bar-Ilan University Faculty of Medicine, Safed, Israel; Peninsula Trauma Network (A.H.), Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom; Division of Trauma and Emergency Surgery (D.J.), UT Health San Antonio, San Antonio, Texas; Special Operations Command Europe (S.K.), Stuttgart, Germany; Transfusion Medicine and Cell Therapy (C.M.), French Military Blood Institute, Clamart, France; 75th Ranger Regiment (E.M.); Surgery (E.M.), University of Colorado Denver, Denver, Colorado; Military Anaesthesia (G.N.), Royal Centre for Defence Medicine, Birmingham, United Kingdom; Combat Casualty Care (N.P.), French Armed Forces Institute of Biomedical Research; Acute Care Surgery, Toulon, France (J.R.), Tufts University School of Medicine, Boston, Massachusetts; Military Medicine and Surgery (M.R.), Australian Defence Force Joint Health Command and Faculty of Medicine, University of Queensland, Queensland, Australia; Interventional Cardiology, Acute & Prehospital Medicine (P.R.), University of St Andrews School of Medicine, St Andrews, Scotland; Department of Military Surgery and Trauma (R.R.), Royal Centre for Defence Medicine, Birmingham, United Kingdom; Division of Trauma, Critical Care & Acute Care Surgery (M.S.), Oregon Health Sciences University, Portland, Oregon; Department of Defense (S.S.), Joint Trauma System; Norwegian Naval Special Operations Commando (H.S.), University of Bergen, Bergen, Norway; Department of Emergency Medicine (J.S.), General Practise (M.S.), Royal Centre for Defence Medicine, Birmingham, United Kingdom; Department of Pediatrics (P.S.), Washington University in St Louis School of Medicine, St Louis, Missouri; Department of Immunology and Transfusion Medicine (G.S.), Norwegian Armed Forces Medical Services, Oslo, Norway; Department of Emergency Medicine (K.W.), University of Michigan, Ann Arbor, Michigan; Combat Casualty Care (S.W.), Medical & Trauma Sciences, Defence Science and Technology Laboratory, Salisbury, United Kingdom; Division of Emergency Medicine (N.W.), Washington University of Medicine, Seattle, Washington; and Institute of Cruise Ship Medicine (S.W.), REVA Air Ambulance, Fort Lauderdale, Florida.

The Trauma Hemostasis and Oxygenation Research (THOR) Network has developed a consensus statement on the role of permissive hypotension in remote damage control resuscitation (RDCR). A summary of the evidence on permissive hypotension follows the THOR Network position on the topic. In RDCR, the burden of time in the care of the patients suffering from noncompressible hemorrhage affects outcomes. Despite the lack of published evidence, and based on clinical experience and expertise, it is the THOR Network's opinion that the increase in prehospital time leads to an increased burden of shock, which poses a greater risk to the patient than the risk of rebleeding due to slightly increased blood pressure, especially when blood products are available as part of prehospital resuscitation.The THOR Network's consensus statement is, "In a casualty with life-threatening hemorrhage, shock should be reversed as soon as possible using a blood-based HR fluid. Whole blood is preferred to blood components. As a part of this HR, the initial systolic blood pressure target should be 100 mm Hg. In RDCR, it is vital for higher echelon care providers to receive a casualty with sufficient physiologic reserve to survive definitive surgical hemostasis and aggressive resuscitation. The combined use of blood-based resuscitation and limiting systolic blood pressure is believed to be effective in promoting hemostasis and reversing shock".
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/TA.0000000000001856DOI Listing
June 2018
-->