Publications by authors named "Johanna G van der Bom"

155 Publications

Von Willebrand Factor Multimer Densitometric Analysis: Validation of the Clinical Accuracy and Clinical Implications in Von Willebrand Disease.

Hemasphere 2021 Mar 17;5(3):e542. Epub 2021 Feb 17.

Department of Hematology, Erasmus MC, University Medical Center Rotterdam, The Netherlands.

Von Willebrand factor (VWF) multimer analysis is important in the classification of von Willebrand disease (VWD). Current visual VWF multimer analysis is time consuming and inaccurate in detecting subtle changes in multimer patterns. Although VWF multimer densitometric analysis may be useful, the accuracy needs further investigation before it can be widely applied. In this study we aimed to validate VWF multimer densitometric analysis in a large cohort of VWD patients and to identify patient characteristics associated with densitometric outcomes. Patients were included from the Willebrand in the Netherlands (WiN) study, in which a bleeding score (BS) was obtained, and blood was drawn. For multimer analysis, citrated blood was separated on an agarose gel and visualized by Western blotting. IMAGEJ was used to generate densitometric images and medium-large VWF multimer index was calculated. We included 560 VWD patients: 328 type 1, 211 type 2, and 21 type 3 patients. Medium-large VWF multimer index performed excellent in distinguishing visually classified normal VWF multimers from reduced high-molecular-weight (HMW) multimers (area under the curve [AUC]: 0.96 [0.94-0.98], < 0.001), normal multimers from absence of HMW multimers (AUC 1.00 [1.00-1.00], < 0.001), and type 2A and 2B from type 2M and 2N (AUC: 0.96 [0.94-0.99], < 0.001). Additionally, higher medium-large VWF multimer index was associated with lower BS in type 1 VWD: β = -7.6 (-13.0 to -2.1), = 0.007, adjusted for confounders. Densitometric analysis of VWF multimers had an excellent accuracy compared with visual multimer analysis and may contribute to a better understanding of the clinical features such as the bleeding phenotype of VWD patients.
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http://dx.doi.org/10.1097/HS9.0000000000000542DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892298PMC
March 2021

Reduction of anti-K-mediated hemolytic disease of newborns after the introduction of a matched transfusion policy: A nation-wide policy change evaluation study in the Netherlands.

Transfusion 2021 Mar 2;61(3):713-721. Epub 2021 Feb 2.

Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, The Netherlands.

Background: During pregnancy, maternal red blood cell (RBC) antibodies can lead to life-threatening fetal hemolysis and anemia. Women can become immunized by a pregnancy or an unmatched transfusion. Our aim was to quantify the effect of a nationwide K-matched transfusion policy for women of childbearing age potential to prevent K-immunization in pregnancy.

Study Design And Methods: In this nation-wide policy change evaluation study we determined the occurrence of RBC antibodies before and after introduction of a K-matched transfusion policy and evaluated the cause K alloimmunization 10 years after introduction of this measure. K-matched transfusion for females under 45 years of age is advised in the Dutch transfusion guideline since 2004. We used laboratory data from pregnancies with RBC antibodies identified in the period 1999-2018 obtained as part of a population-based screening program in the Netherlands.

Results: Tests of 36 286 pregnancies produced a positive antibody screening result which concerned anti-K in 1550 pregnancies. The occurrence of anti-K decreased from 67.9 to 20.2 per 100 000 pregnancies. The relative risk reduction was 0.70 which largely exceeded the relative risk reduction of 0.27 for antibodies against RBC antigens for which no preventive matching is required. The number of pregnancies at risk for anti-K-mediated disease decreased from 9.7 to 4.2 per 100 000 pregnancies.

Conclusions: A K-matched transfusion policy is associated with a major decrease in a number of pregnant women with anti-K and pregnancies at risk for anti-K-mediated disease. A relatively simple measure is now shown to impact prevention of hemolytic disease in the fetus and newborn.
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http://dx.doi.org/10.1111/trf.16276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986406PMC
March 2021

Biological stratification of clinical disease courses in childhood immune thrombocytopenia.

J Thromb Haemost 2021 Apr 18;19(4):1071-1081. Epub 2021 Mar 18.

Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, The Netherlands.

Background: In childhood immune thrombocytopenia (ITP), an autoimmune bleeding disorder, there is a need for better prediction of individual disease courses and treatment outcomes.

Objective: To predict the response to intravenous immunoglobulins (IVIg) and ITP disease course using genetic and immune markers.

Methods: Children aged younger than 7 years with newly diagnosed ITP (N = 147) from the Treatment With or Without IVIG for Kids with ITP study were included, which randomized children to an IVIg or observation group. A total of 46 variables were available: clinical characteristics, targeted genotyping, lymphocyte immune phenotyping, and platelet autoantibodies.

Results: In the treatment arm, 48/80 children (60%) showed a complete response (platelets ≥100 × 10 /L) that lasted for at least 1 month (complete sustained response [CSR]) and 32 exhibited no or a temporary response (absence of a sustained response [ASR]). For a biological risk score, five variables were selected by regularized logistic regression that predicted ASR vs CSR: (1) hemoglobin; (2) platelet count; (3) genetic polymorphisms of Fc-receptor (FcγR) IIc; (4) the presence of immunoglobulin G (IgG) anti-platelet antibodies; and (5) preceding vaccination. The ASR sensitivity was 0.91 (95% confidence interval, 0.80-1.00) and specificity was 0.67 (95% confidence interval, 0.53-0.80). In the 67 patients of the observation arm, this biological score was also associated with recovery during 1 year of follow-up. The addition of the biological score to a predefined clinical score further improved the discrimination of favorable ITP disease courses.

Conclusions: The prediction of disease courses and IVIg treatment responses in ITP is improved by using both clinical and biological stratification.
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http://dx.doi.org/10.1111/jth.15232DOI Listing
April 2021

ADAMTS-13 and bleeding phenotype in von Willebrand disease.

Res Pract Thromb Haemost 2020 Nov 31;4(8):1331-1339. Epub 2020 Oct 31.

Department of Hematology Erasmus MC, University Medical Center Rotterdam Rotterdam The Netherlands.

Background: The bleeding phenotype of von Willebrand disease (VWD) varies highly between patients and can only partly be explained by von Willebrand factor (VWF) parameters. By cleaving large VWF multimers into smaller, less active multimers, ADAMTS-13 is an important regulator of VWF activity. However, it is unknown what the role of ADAMTS-13 is in individuals with VWD.

Objectives: We therefore studied how ADAMTS-13 activity is associated with the laboratory and bleeding phenotype in individuals with VWD.

Methods: We measured ADAMTS-13 activity using the fluorescence resonance energy transfer substrate VWF 73 assay in 638 individuals with VWD in the nationwide cross-sectional Willebrand in the Netherlands study and in 36 healthy controls. The bleeding phenotype was assessed using the Tosetto bleeding score.

Results: ADAMTS-13 activity was similar in individuals with VWD (109% ± 20.6%) and controls (110% ± 19.7%). ADAMTS-13 activity was higher in individuals with VWD with type 3 than those with type 1 (mean difference, 11.8%; 95% confidence interval [CI], 2.9%-20.8%) or type 2 (mean difference, 16.1%; 95% CI, 7.1%-25.1%). ADAMTS-13 activity was not associated with the Tosetto bleeding score (0.1 Tosetto bleeding score increase per 10% ADAMTS-13 increase, 95% CI, -0.2 to 0.3). Furthermore, ADAMTS-13 activity did not differ between individuals with and without a bleeding event during the year preceding blood sampling (mean difference, 1.4%; 95% CI, -2.1% to 4.9%).

Conclusion: ADAMTS-13 activity was highest in individuals with type 3 VWD, but it had only minor associations with VWF parameters. ADAMTS-13 activity does not influence the bleeding phenotype in individuals with VWD.
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http://dx.doi.org/10.1002/rth2.12442DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7695560PMC
November 2020

Association between renal failure and red blood cell alloimmunization among newly transfused patients.

Transfusion 2021 Jan 9;61(1):35-41. Epub 2020 Dec 9.

Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.

Background: Renal failure and renal replacement therapy (RRT) affect the immune system and could therefore modulate red blood cell (RBC) alloimmunization after transfusion.

Study Design And Methods: We performed a nationwide multicenter case-control study within a source population of newly transfused patients between 2005 and 2015. Using conditional multivariate logistic regression, we compared first-time transfusion-induced RBC alloantibody formers (N = 505) with two nonalloimmunized recipients with similar transfusion burden (N = 1010).

Results: Renal failure was observed in 17% of the control and 13% of the case patients. A total of 41% of the control patients and 34% of case patients underwent acute RRT. Renal failure without RRT was associated with lower alloimmunization risks after blood transfusion (moderate renal failure: adjusted relative rate [RR], 0.82 [95% confidence interval (CI), 0.67-1.01]); severe renal failure, adjusted RR, 0.76 [95% CI, 0.55-1.05]). With severe renal failure patients mainly receiving RRT, the lowest alloimmunization risk was found in particularly these patients [adjusted RR 0.48 (95% CI 0.39-0.58)]. This was similar for patients receiving RRT for acute or chronic renal failure (adjusted RR, 0.59 [95% CI, 0.46-0.75]); and adjusted RR, 0.62 [95% CI 0.45-0.88], respectively).

Conclusion: These findings are indicative of a weakened humoral response in acute as well as chronic renal failure, which appeared to be most pronounced when treated with RRT. Future research should focus on how renal failure and RRT mechanistically modulate RBC alloimmunization.
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http://dx.doi.org/10.1111/trf.16166DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839777PMC
January 2021

Changes in the Use of Fresh-Frozen Plasma Transfusions in Preterm Neonates: A Single Center Experience.

J Clin Med 2020 Nov 23;9(11). Epub 2020 Nov 23.

Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, 2333ZA Leiden, The Netherlands.

The aim of this study was to evaluate changes in the use of fresh-frozen plasma (FFP) transfusions and the use of clotting tests in preterm neonates in our center over the past two decades. In this retrospective cohort analysis, we included all consecutive neonates with a gestational age at birth between 24 + 0 and 31 + 6 weeks admitted to our neonatal intensive care unit (NICU) between 2004 and 2019. We divided all included neonates into three consecutive time epochs according to date of birth: January 2004 to April 2009, May 2009 to August 2014 and September 2014 to December 2019. The main outcomes were the use of FFP transfusion, coagulation testing and the indications for FFP transfusion. The percentage of preterm neonates receiving FFP transfusion decreased from 5.7% (47/824) to 3.7% (30/901) to 2.0% (17/852) from the first epoch to the last epoch ( < 0.001). Additionally, the rate of neonates undergoing coagulation testing decreased from 24.3% (200/824) to 14.5% (131/901) to 8% (68/852) over the epochs ( < 0.001). Most FFP transfusions were prescribed prophylactically based on prolongation of activated partial thromboplastin time (aPTT) or prothrombin time (PT) (56%). In conclusion, both the use of FFP transfusions and the use of coagulation tests decreased significantly over the years. The majority of the FFP transfusions were administrated prophylactically for abnormal coagulation tests.
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http://dx.doi.org/10.3390/jcm9113789DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7700187PMC
November 2020

Mortality, life expectancy, and causes of death of persons with hemophilia in the Netherlands 2001-2018.

J Thromb Haemost 2021 Mar 18;19(3):645-653. Epub 2020 Dec 18.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.

Background: Treatment of patients with hemophilia has advanced over the past decades, but it is unknown whether this has resulted in a normal life expectancy in the Netherlands.

Objective: This observational cohort study aimed to assess all-cause and cause-specific mortality in patients with hemophilia in the Netherlands between 2001 and 2018 and to compare mortality and life expectancy with previous survival assessments from 1973 onward.

Patients/methods: All 1066 patients with hemophilia who participated in a nationwide survey in 2001 were followed until July 2018.

Results: Information on 1031 individuals (97%) was available, of whom 142 (14%) deceased during follow-up. Compared with the general Dutch male population, mortality of patients with hemophilia was still increased (standardized mortality ratio: 1.4, 95% confidence interval: 1.2-1.7). Intracranial bleeding and malignancies were the most common causes of death. Estimated median life expectancy of patients with hemophilia was 77 years, 6 years lower than the median life expectancy of the general Dutch male population (83 years). Over the past 45 years, death rates of patients with hemophilia have consistently decreased, approaching the survival experience of the general population. Over the past decades, mortality due to human immunodeficiency virus and hepatitis C virus infections has decreased, death due to intracranial hemorrhages has increased, and death due to ischemic heart disease has remained consistently low over time.

Conclusions: Survival in patients with hemophilia in the Netherlands has improved over time but is still lower than that of the general population.
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http://dx.doi.org/10.1111/jth.15182DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986360PMC
March 2021

Thrombocytopenia and the effect of platelet transfusions on the occurrence of intracranial hemorrhage in patients with acute leukemia - a nested case-control study.

Ann Hematol 2021 Jan 17;100(1):261-271. Epub 2020 Oct 17.

Jon J van Rood Center for Clinical Transfusion Medicine, Sanquin/LUMC, Leiden, The Netherlands.

We designed a study to describe the incidence of intracranial hemorrhage according to severity and duration of thrombocytopenia and to quantify the associations of platelet transfusions with intracranial hemorrhage in patients with acute leukemia. In this case-control study nested in a cohort of 859 leukemia patients, cases (n = 17) were patients diagnosed with intracranial hemorrhage who were matched with control patients (n = 55). We documented platelet counts and transfusions for seven days before the intracranial hemorrhage in cases and in a "matched" week for control patients. Three measures of platelet count exposure were assessed in four potentially important time periods before hemorrhage. Among these leukemia patients, we observed the cumulative incidence of intracranial hemorrhage of 3.5%. Low platelet counts were, especially in the three to seven days preceding intracranial hemorrhage, associated with the incidence of intracranial hemorrhage, although with wide confidence intervals. Platelet transfusions during the week preceding the hemorrhage were associated with higher incidences of intracranial hemorrhage; rate ratios (95% confidence interval) for one or two platelet transfusions and for more than two transfusions compared with none were 4.04 (0.73 to 22.27) and 8.91 (1.53 to 51.73) respectively. Thus, among acute leukemia patients, the risk of intracranial hemorrhage was higher among patients with low platelet counts and after receiving more platelet transfusions. Especially, the latter is likely due to clinical factors leading to increased transfusion needs.
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http://dx.doi.org/10.1007/s00277-020-04298-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7782440PMC
January 2021

A clinical prediction score for transient versus persistent childhood immune thrombocytopenia.

J Thromb Haemost 2021 01 27;19(1):121-130. Epub 2020 Nov 27.

Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, the Netherlands.

Essentials There is a need for improved tools to predict persistent and chronic immune thrombocytopenia (ITP). We developed and validated a clinical prediction model for recovery from newly diagnosed ITP. The Childhood ITP Recovery Score predicts transient vs. persistent ITP and response to intravenous immunoglobulins. The score may serve as a useful tool for clinicians to individualize patient care. ABSTRACT: Background Childhood immune thrombocytopenia (ITP) is an autoimmune bleeding disorder. The prognosis (transient, persistent, or chronic ITP) remains difficult to predict. The morbidity is most pronounced in children with persistent and chronic ITP. Clinical characteristics are associated with ITP outcomes, but there are no validated multivariate prediction models. Objective Development and external validatation of the Childhood ITP Recovery Score to predict transient versus persistent ITP in children with newly diagnosed ITP. Methods Patients with a diagnosis platelet count ≤ 20 × 10 /L and age below 16 years were included from two prospective multicenter studies (NOPHO ITP study, N = 377 [development cohort]; TIKI trial, N = 194 [external validation]). The primary outcome was transient ITP (complete recovery with platelets ≥100 × 10 /L 3 months after diagnosis) versus persistent ITP. Age, sex, mucosal bleeding, preceding infection/vaccination, insidious onset, and diagnosis platelet count were used as predictors. Results In external validation, the score predicted transient versus persistent ITP at 3 months follow-up with an area under the receiver operating characteristic curve of 0.71. In patients predicted to have a high chance of recovery, we observed 85%, 90%, and 95% recovered 3, 6, and 12 months after the diagnosis. For patients predicted to have a low chance of recovery, this was 32%, 46%, and 71%. The score also predicted cessation of bleeding symptoms and the response to intravenous immunoglobulins (IVIg). Conclusion The Childhood ITP Recovery Score predicts prognosis and may be useful to individualize clinical management. In future research, the additional predictive value of biomarkers can be compared to this score. A risk calculator is available (http://www.itprecoveryscore.org).
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http://dx.doi.org/10.1111/jth.15125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839442PMC
January 2021

The factor VIII treatment history of non-severe hemophilia A.

J Thromb Haemost 2020 12 28;18(12):3203-3210. Epub 2020 Sep 28.

The Royal London Haemophilia Centre, QMUL, Barts and the London School of Medicine and Dentistry, London, UK.

Background: In patients with non-severe hemophilia A, we lack detailed knowledge on the timing of treatment with factor VIII (FVIII) concentrates. This knowledge could provide information about the expected treatment timing in patients with severe hemophilia A treated with non-replacement therapies.

Objective: To assess the FVIII treatment history in patients with non-severe hemophilia A.

Methods: Patients with non-severe hemophilia (baseline FVIII activity [FVIII:C] 2-40 IU/dL) were included from the INSIGHT study. The primary outcome was median age at first FVIII exposure (ED1). In a subgroup of patients for whom more detailed information was available, we analyzed the secondary outcomes: median age at first 20 EDs, annualized bleeding rate for all bleeds (ABR), joint bleeds (AJBR), and major spontaneous bleeds (ASmBR).

Results: In the total cohort (n = 1013), median baseline FVIII activity was 8 IU/dL (interquartile range [IQR] 4-15) and the median age at ED1 was 3.7 years (IQR 1.4-7.7). Median age at ED1 rose from 2.5 years (IQR 1.2-5.7) in patients with FVIII:C 2-5 IU/dL to 9.7 years (IQR 4.8-16.0) in patients with FVIII:C 25-40 IU/dL. In the subgroup (n = 104), median age at ED1, ED5, ED10, and ED20 was 4.0 years (IQR 1.4-7.6), 5.6 years (IQR 2.9-9.3), 7.5 years (IQR 4.4-11.3), and 10.2 years (IQR 6.5-14.2), respectively. Median ABR, AJBR, and ASmBR were 1.1 (IQR 0.5-2.6), 0.3 (IQR 0.1-0.7), and 0 (IQR 0-0), respectively.

Conclusion: This study demonstrates that in non-severe hemophilia A, the age at first FVIII exposure increases with baseline FVIII:C and that major spontaneous bleeds rarely occur.
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http://dx.doi.org/10.1111/jth.15076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756346PMC
December 2020

Risk factors for bleeding in haemato-oncology patients-a nested case-control study: The BITE study protocol (Bleeding In Thrombocytopenia Explained).

BMJ Open 2020 06 30;10(6):e034710. Epub 2020 Jun 30.

Jon J van Rood Center for Clinical Transfusion Research, Sanquin/LUMC, Leiden, The Netherlands

Introduction: Haemato-oncological patients often receive platelet count driven prophylactic platelet transfusions to prevent bleeding. However, many prophylactically transfused patients still bleed. More knowledge on risk factors for bleeding is therefore needed. This will enable identification of bleeding risk profiles on which future transfusion policy can be optimised. The present BITE study (Bleeding In Thrombocytopenia Explained) aims to identify clinical conditions and biomarkers that are associated with clinically relevant bleeding events.

Methods And Analysis: A matched case-control study nested in a cohort of haemato-oncological patients in the Netherlands. We collect a limited number of variables from all eligible patients, who together form the source population. These patients are followed for the occurrence of clinically relevant bleeding. Consenting patients of the source population form the cohort. Cases from the cohort are frequency matched to selected control patients for the nested case-control study. Of both case and control patients more detailed clinical data is collected.

Study Population: Adult haemato-oncological patients, who are admitted for intensive chemotherapeutic treatment or stem cell transplantation, or who received such treatments in the past and are readmitted for disease or treatment-related adverse events.

Statistical Analysis: Bleeding incidences will be calculated for the total source population, as well as for different subgroups. The association between potential risk factors and the occurrence of bleeding will be analysed using conditional logistic regression, to account for matching of case and control patients.

Ethics And Dissemination: The study was approved by the Medical Research Ethics Committee Leiden Den Haag and Delft, and the Radboudumc Committee on Research Involving Human Subjects. Approval in seven other centres is foreseen. Patients will be asked for written informed consent and data is coded before analyses, according to Dutch privacy law. Results will be published in peer-reviewed journals.

Trial Registration Number: NL62499.058.17. NCT03505086; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2019-034710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7328810PMC
June 2020

Study protocol and pilot results of an observational cohort study evaluating effect of red blood cell transfusion on oxygenation and mitochondrial oxygen tension in critically ill patients with anaemia: the INsufficient Oxygenation in the Intensive Care Unit (INOX ICU-2) study.

BMJ Open 2020 05 17;10(5):e036351. Epub 2020 May 17.

Clinical Transfusion Research, Sanquin Research Clinical Transfusion Research, Leiden, Zuid-Holland, The Netherlands

Introduction: The recently developed protoporphyrin IX-triple state lifetime technique measures mitochondrial oxygenation tension (mitoPO) in vivo at the bedside. MitoPOmight be an early indicator of oxygen disbalance in cells of critically ill patients and therefore may support clinical decisions regarding red blood cell (RBC) transfusion. We aim to investigate the effect of RBC transfusion and the associated changes in haemoglobin concentration on mitoPO and other physiological measures of tissue oxygenation and oxygen balance in critically ill patients with anaemia. We present the protocol and pilot results for this study.

Methods And Analysis: We perform a prospective multicentre observational study in three mixed intensive care units in the Netherlands with critically ill patients with anaemia in whom an RBC transfusion is planned. The skin of the anterior chest wall of the patients is primed with a 5-aminolevulinic acid patch for 4 hours for induction of mitochondrial protoporphyrin-IX to enable measurements of mitoPO, which is done with the COMET monitoring device. At multiple predefined moments, before and after RBC transfusion, we assess mitoPO and other physiological parameters of oxygen balance and tissue oxygenation. Descriptive statistics will be used to describe the data. A linear mixed-effect model will be used to study the association between RBC transfusion and mitoPO and other traditional parameters of oxygenation, oxygen delivery and oxygen balance. Missing data will be imputed using multiple imputation methods.

Ethics And Dissemination: The institutional ethics committee of each participating centre approved the study (reference P16.303), which will be conducted according to the 1964 Helsinki declaration and its later amendments. The results will be submitted for publication in peer-reviewed journals and presented at scientific conferences.

Trial Registration Number: NCT03092297.
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http://dx.doi.org/10.1136/bmjopen-2019-036351DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239524PMC
May 2020

The Added Value of Lactate and Lactate Clearance in Prediction of In-Hospital Mortality in Critically Ill Patients With Sepsis.

Crit Care Explor 2020 Mar 24;2(3):e0087. Epub 2020 Mar 24.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

We investigated the added predictive value of lactate and lactate clearance to the Acute Physiology and Chronic Health Evaluation IV model for predicting in-hospital mortality in critically ill patients with sepsis.

Design: Retrospective observational cohort study.

Setting: Mixed ICU of Leiden University Medical Center, The Netherlands.

Patients: Critically ill patients adult patients with sepsis who have been admitted to the ICU of Leiden University Medical Center, The Netherlands, from 2006 to January 2018.

Interventions: None.

Measurements And Main Results: We fitted a baseline model with the Acute Physiology and Chronic Health Evaluation IV predictors and added 13 prespecified combinations of lactate and lactate clearance at 0, 6 and 24 hours after admission to create a set of extended models to compare with the baseline Acute Physiology and Chronic Health Evaluation IV model. Among 603 ICU admissions, 451 patients met the inclusion criteria. A total of 160 patients died in-hospital, of which 106 died in the ICU. Their lactate and lactate clearance measurements were higher at all time points than those of survivors. The Akaike Information Criterion score improved in 10 of 13 prespecified extended models, with best performance for models that included lactate at 24 hours, alone or in combination with lactate at admission or lactate clearance at 24 hours. We compared the observed and predicted probabilities of in-hospital mortality of the baseline Acute Physiology and Chronic Health Evaluation IV model with the best model in our data, lactate at 24 hours added to the Acute Physiology and Chronic Health Evaluation IV model. This resulted in an increase in specificity of 29.9% (95% CI, 18.9-40.9%).

Conclusions: Lactate measurements at 24 hours after admission add predictive value to the prediction of mortality with Acute Physiology and Chronic Health Evaluation IV among ICU patients with sepsis. External validation is needed to develop extended prediction models.
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http://dx.doi.org/10.1097/CCE.0000000000000087DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7098542PMC
March 2020

Product type and the risk of inhibitor development in nonsevere haemophilia A patients: a case-control study.

Br J Haematol 2020 06 22;189(6):1182-1191. Epub 2020 Mar 22.

Department of Pediatric Hematology, Immunology and Infectious Diseases, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.

Inhibitor development is a major complication of treatment with factor VIII concentrates in nonsevere haemophilia A. It has been suggested that plasma-derived factor VIII (FVIII) concentrates elicit fewer inhibitors than recombinant FVIII concentrates, but studies in severe haemophilia A patients have shown conflicting results. We designed a case-control study to investigate the clinical and genetic risk factors for inhibitor development in nonsevere haemophilia A patients. We investigated whether the type of FVIII concentrate was associated with inhibitor development in nonsevere haemophilia A patients. This nested case-control study includes 75 inhibitor patients and 223 controls, from a source population of the INSIGHT study, including all nonsevere haemophilia A patients (FVIII:C 2-40%) that were treated with FVIII concentrates in 33 European and one Australian centre. Cases and controls were matched for date of birth and cumulative number of exposure days (CED) to FVIII concentrate. A conditional logistic regression model was used to calculate unadjusted and adjusted odds ratios. No increased risk for inhibitor development was found for any type of FVIII concentrate; either when comparing recombinant FVIII concentrates to plasma-derived FVIII concentrates (adjusted odds ratio 0·96, 95% confidence interval (CI) 0·36-2·52) or for specific types of FVIII concentrates.
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http://dx.doi.org/10.1111/bjh.16490DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318706PMC
June 2020

Best timing of tranexamic acid administration for bleeding after trauma or childbirth remains to be established.

BMJ Evid Based Med 2020 Feb 13. Epub 2020 Feb 13.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

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http://dx.doi.org/10.1136/bmjebm-2019-111290DOI Listing
February 2020

Association of Timing of Plasma Transfusion With Adverse Maternal Outcomes in Women With Persistent Postpartum Hemorrhage.

JAMA Netw Open 2019 11 1;2(11):e1915628. Epub 2019 Nov 1.

Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands.

Importance: Early plasma transfusion for women with severe postpartum hemorrhage (PPH) is recommended to prevent coagulopathy. However, there is no comparative, quantitative evidence on the association of early plasma transfusion with maternal outcomes.

Objective: To compare the incidence of adverse maternal outcomes among women who received plasma during the first 60 minutes of persistent PPH vs women who did not receive plasma for similarly severe persistent PPH.

Design, Setting, And Participants: This multicenter cohort study used a consecutive sample of women with persistent PPH, defined as PPH refractory to first-line measures to control bleeding, between January 1, 2011, and January 1, 2013. Time-dependent propensity score matching was used to select women who received plasma during the first 60 minutes of persistent PPH and match each of them with a woman who had shown the same severity and received the same treatment of PPH but who had not received plasma at the moment of matching. Transfusions were not guided by coagulation tests. Statistical analysis was performed from June 2018 to June 2019.

Exposures: Transfusion of plasma during the first 60 minutes of persistent PPH vs no or later plasma transfusion.

Main Outcomes And Measures: Incidence of adverse maternal outcomes, defined as a composite of death, hysterectomy, or arterial embolization.

Results: This study included 1216 women (mean [SD] age, 31.6 [5.0] years) with persistent PPH, of whom 932 (76.6%) delivered vaginally and 780 (64.1%) had PPH caused by uterine atony. Seven women (0.6%) died because of PPH, 62 women (5.1%) had a hysterectomy, and 159 women (13.1%) had arterial embolizations. Among women who received plasma during the first 60 minutes of persistent PPH, 114 women could be matched with a comparable woman who had not received plasma at the moment of matching. The incidence of adverse maternal outcomes was similar between the women, with adverse outcomes recorded in 24 women (21.2%) who received early plasma transfusion and 23 women (19.9%) who did not receive early plasma transfusion (odds ratio, 1.09; 95% CI, 0.57-2.09). Results of sensitivity analyses were comparable to the primary results.

Conclusions And Relevance: In this cohort study, initiation of plasma transfusion during the first 60 minutes of persistent PPH was not associated with adverse maternal outcomes compared with no or later plasma transfusion, independent of severity of PPH.
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http://dx.doi.org/10.1001/jamanetworkopen.2019.15628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902812PMC
November 2019

Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death.

Blood 2019 12;134(26):2354-2360

Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.

The Platelets for Neonatal Thrombocytopenia (PlaNeT-2) trial reported an unexpected overall benefit of a prophylactic platelet transfusion threshold of 25 × 109/L compared with 50 × 109/L for major bleeding and/or mortality in preterm neonates (7% absolute-risk reduction). However, some neonates in the trial may have experienced little benefit or even harm from the 25 × 109/L threshold. We wanted to assess this heterogeneity of treatment effect in the PlaNet-2 trial, to investigate whether all preterm neonates benefit from the low threshold. We developed a multivariate logistic regression model in the PlaNet-2 data to predict baseline risk of major bleeding and/or mortality for all 653 neonates. We then ranked the neonates based on their predicted baseline risk and categorized them into 4 risk quartiles. Within these quartiles, we assessed absolute-risk difference between the 50 × 109/L- and 25 × 109/L-threshold groups. A total of 146 neonates died or developed major bleeding. The internally validated C-statistic of the model was 0.63 (95% confidence interval, 0.58-0.68). The 25 × 109/L threshold was associated with absolute-risk reduction in all risk groups, varying from 4.9% in the lowest risk group to 12.3% in the highest risk group. These results suggest that a 25 × 109/L prophylactic platelet count threshold can be adopted in all preterm neonates, irrespective of predicted baseline outcome risk. Future studies are needed to improve the predictive accuracy of the baseline risk model. This trial was registered at www.isrctn.com as #ISRCTN87736839.
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http://dx.doi.org/10.1182/blood.2019000899DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933290PMC
December 2019

Patient Perspectives on Novel Treatments in Haemophilia: A Qualitative Study.

Patient 2020 04;13(2):201-210

Department of Clinical Epidemiology, Leiden University Medical Center, Postzone C7-P, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.

Background And Objective: New treatments for haemophilia are under development or entering the market, including extended half-life products, designer drugs and gene therapy, thereby increasing treatment options for haemophilia. It is currently unknown how people with haemophilia decide whether to switch to a new treatment. Therefore, the objective of this study was to explore what factors may play a role when Dutch patients and parents of boys with moderate or severe haemophilia make decisions about whether to switch to a different treatment, and how disease and treatment characteristics may affect these decisions. This may aid clinical teams in tailored information provision and shared decision making.

Methods: We conducted interviews among adults with moderately severe or severe haemophilia and parents of young boys with severe haemophilia. We aimed to include participants from a variety of backgrounds in terms of involvement in the haemophilia community, age, treatment centre and treatments. Participants were recruited through the Netherlands Haemophilia Society and a haemophilia treatment centre. Semi-structured interviews were recorded and transcribed verbatim. Thematic content analysis was used to analyse the data.

Results: Twelve people with haemophilia and two mothers of boys with haemophilia were included. In general, participants reported to be satisfied with their current treatment. However, they considered ease of use of the medication (fewer injections, easier handling, alternative administration) an added value of new treatments. Participants were aware of the high cost of coagulation factor products and some expressed their concern about the Netherlands Haemophilia Society's long-term willingness to pay for current and novel treatments, especially for increased usage due to high-risk activities. Participants also expressed their concerns about the short- and long-term safety of new treatments and believed the effects of gene therapy were not yet fully understood. Participants expected their treatment team to inform them when a particular new treatment would be suitable for them.

Conclusions: With the number of treatment options set to increase, it is important for healthcare providers to be aware of how patient experiences shape patients' decisions about new therapies.
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http://dx.doi.org/10.1007/s40271-019-00395-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7075838PMC
April 2020

Clinical characteristics of women captured by extending the definition of severe postpartum haemorrhage with 'refractoriness to treatment': a cohort study.

BMC Pregnancy Childbirth 2019 Oct 17;19(1):361. Epub 2019 Oct 17.

Centre for Clinical Transfusion Research, Sanquin/LUMC, Leiden, the Netherlands.

Background: The absence of a uniform and clinically relevant definition of severe postpartum haemorrhage hampers comparative studies and optimization of clinical management. The concept of persistent postpartum haemorrhage, based on refractoriness to initial first-line treatment, was proposed as an alternative to common definitions that are either based on estimations of blood loss or transfused units of packed red blood cells (RBC). We compared characteristics and outcomes of women with severe postpartum haemorrhage captured by these three types of definitions.

Methods: In this large retrospective cohort study in 61 hospitals in the Netherlands we included 1391 consecutive women with postpartum haemorrhage who received either ≥4 units of RBC or a multicomponent transfusion. Clinical characteristics and outcomes of women with severe postpartum haemorrhage defined as persistent postpartum haemorrhage were compared to definitions based on estimated blood loss or transfused units of RBC within 24 h following birth. Adverse maternal outcome was a composite of maternal mortality, hysterectomy, arterial embolisation and intensive care unit admission.

Results: One thousand two hundred sixty out of 1391 women (90.6%) with postpartum haemorrhage fulfilled the definition of persistent postpartum haemorrhage. The majority, 820/1260 (65.1%), fulfilled this definition within 1 h following birth, compared to 819/1391 (58.7%) applying the definition of ≥1 L blood loss and 37/845 (4.4%) applying the definition of ≥4 units of RBC. The definition persistent postpartum haemorrhage captured 430/471 adverse maternal outcomes (91.3%), compared to 471/471 (100%) for ≥1 L blood loss and 383/471 (81.3%) for ≥4 units of RBC. Persistent postpartum haemorrhage did not capture all adverse outcomes because of missing data on timing of initial, first-line treatment.

Conclusion: The definition persistent postpartum haemorrhage identified women with severe postpartum haemorrhage at an early stage of haemorrhage, unlike definitions based on blood transfusion. It also captured a large majority of adverse maternal outcomes, almost as large as the definition of ≥1 L blood loss, which is commonly applied as a definition of postpartum haemorrhage rather than severe haemorrhage.
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http://dx.doi.org/10.1186/s12884-019-2499-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6798374PMC
October 2019

HLA-matched platelet transfusions are effective only in refractory patients with positive HLA antibody screening.

Transfusion 2019 11 11;59(11):3303-3307. Epub 2019 Oct 11.

Unit Transfusion Medicine, Sanquin Blood Bank, Amsterdam, The Netherlands.

Background: Recipients of platelet transfusions with 1-hour corrected count increments (1hCCIs) of 7.5 or less on two subsequent platelet transfusions with random platelets may benefit from human leukocyte antigen (HLA)-matched platelet concentrates. We aimed to quantify the efficacy of HLA-matched platelets concentrates expressed in 1hCCIs.

Methods: We performed a cohort study among consecutive refractory patients who received HLA-matched platelet concentrates in the Netherlands between 1994 and 2017. We performed mixed-model linear regression comparing 1hCCIs after HLA split-antigen-matched transfusions with 1hCCIs after HLA-mismatched transfusions, adjusted for within-patient correlations. A donor-to-patient match was categorized as a split-match if all donor HLA-A and -B antigens were present in the patient as well; that is, donor and patient were HLA identical or compatible. Subgroup analyses were performed for patients with positive or negative HLA antibody screens. Finally, the additional effect of ABO mismatches on 1hCCIs was investigated.

Results: The 1hCCI after an HLA-matched transfusion was 14.09 (95% reference interval, 1.13-29.89). This was 1.94 (95% confidence interval [CI], 0.74-3.15) higher than 1hCCI after HLA-mismatched transfusions. In patients with negative HLA antibody screening tests, HLA matching did not affect 1hCCIs. Conditional on HLA matching, 1hCCIs decreased by 3.70 (95% CI, -5.22 to -2.18) with major ABO mismatches.

Conclusion: Matched platelet concentrates yielded maximal 1hCCIs, whereas mismatched transfusions still resulted in adequate increments. There is no indication for HLA-matched platelets in patients with negative antibody screens.
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http://dx.doi.org/10.1111/trf.15530DOI Listing
November 2019

Patient-centred care in haemophilia: Patient perspectives on visualization and participation in decision-making.

Haemophilia 2019 Nov 17;25(6):938-945. Epub 2019 Sep 17.

School of Nursing, Trinity Western University, Langley, Canada.

Introduction And Aim: The British Columbia Adult Haemophilia Team recently adopted a patient-centred care approach. The team presented visual information on an individual's pharmacokinetic profile and bleed history and encouraged patients to participate in treatment decisions. This qualitative study explored how this approach changed patients' understanding of haemophilia and how it facilitated them to make treatment decisions.

Methods: We interviewed 18 males with mild, moderate or severe haemophilia, using a convenience sample from the adult haemophilia clinic at St. Paul's hospital in Vancouver, Canada. Interviews were recorded and transcribed verbatim and analyzed using descriptive content analysis.

Results: Most participants reported that reviewing visual information with the Clinic Team helped them in their communication with their care providers during their annual review clinic appointment. Despite this improved communication, for some the most important feature of their treatment was that they had switched from on-demand treatment to prophylactic treatment in recent years and were able to prevent bleeds. Almost half of the participants reported that the visual information presented increased their understanding of haemophilia and the pharmacokinetics of coagulation factor. Three patients improved their treatment adherence or had changed their prophylaxis schedules based on this. Most participants felt that they were involved in decision-making about their treatment schedule, which they appreciated. On the other hand, two participants thought the Clinic Team should make these decisions.

Conclusion: Participants perceived the patient-centred prophylaxis approach helpful because it enhanced communication with the Clinic Team, increased their understanding of haemophilia and pharmacokinetics of coagulation factor and facilitated treatment decisions.
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http://dx.doi.org/10.1111/hae.13830DOI Listing
November 2019

Effect of storage of platelet concentrates in PAS-B, PAS-C, or plasma on transfusion reactions.

Transfusion 2019 10 10;59(10):3140-3145. Epub 2019 Sep 10.

Center for Clinical Transfusion Research, Sanquin/LUMC, Leiden, The Netherlands.

Background: Reports on the clinical consequences of longer storage time of platelet concentrates are contradictory. The objective of this study was to assess whether longer storage times are associated with a higher risk of transfusion reactions.

Study Design And Methods: We gathered storage times of pooled platelet concentrates related to transfusion reactions reported to the national hemovigilance office from 2004 to 2015. These were combined with storage times of platelet concentrates in the reference population to compare incidences of transfusion-associated circulatory overload, transfusion-related acute lung injury, allergic reactions, febrile nonhemolytic reactions, and "other" reactions between storage time categories.

Results: A total of 567,053 platelet concentrates and 1870 transfusion reactions were analyzed. Among platelet additive solution (PAS)-B platelet recipients, the odds ratio of a storage time of 4 to 5 days compared to 1 to 3 days was 1.60 (95% confidence interval [CI], 1.17-2.18) for allergic, and 1.47 (1.09-1.98) for febrile reactions. For PAS-C platelet recipients, the odds ratio for allergic reactions was 3.78 (95% CI, 1.31-10.9) for 4 to 5 days, and 4.57 (95% CI, 1.57-13.4) for 6- to 7-day-old platelets when compared to 1- to 3-day-old units. In all other studied reaction types, no statistically significant association was observed in platelets in plasma, PAS-B, and PAS-C.

Conclusions: In plasma platelets, longer storage time was not associated with a higher incidence of transfusion reactions. In PAS platelets, longer storage time was associated with higher transfusion reaction incidences, in particular for allergic reactions with both PAS fluids and febrile reactions with PAS-B. This indicates that the effect of storage time is different for different reaction types and depends on the storage fluid.
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http://dx.doi.org/10.1111/trf.15497DOI Listing
October 2019

Determinants of transfusion decisions in the ICU: haemoglobin concentration, what else? - a retrospective cohort study.

Vox Sang 2019 Nov 8;114(8):816-825. Epub 2019 Sep 8.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Background And Objectives: The aim of this study was to assess potentially relevant clinical characteristics which influence the decision to transfuse red cells in critically ill patients with low haemoglobin concentrations (6.0-10.0 g/dl).

Materials And Methods: This was a retrospective observational cohort study of patients admitted between November 2004 and May 2016 at the intensive care unit (ICU) of the Leiden University Medical Center, Netherlands. Haemoglobin measurements, clinical variables and the subsequent transfusion decision were extracted from the electronic health records. Clinical variables were grouped by organ system. We first examined the association of each of the clinical variables with the decision to transfuse during the following 6 h after a haemoglobin measurement using generalized estimating equations. We then compared the predictive abilities of single variables within an organ system and the predictive ability of an organ system's combined variables using the change in Akaike information criterion (AIC).

Results: A total of 83 394 haemoglobin measurements of 10 947 ICU admissions were included. Haemoglobin concentration was the most predictive for red cell transfusion. After the haemoglobin concentration, the combined variables for General Health, followed by the organ systems Cardiovascular and Pulmonary, were most predictive for red cell transfusion. Within these organ systems, the APACHE II score, referring department, APACHE admission diagnosis subgroup, troponin concentration, lactate concentration, respiratory rate, PaO /FiO and ventilation mode had the highest predictive ability.

Conclusion: Haemoglobin concentration is the dominant predictor for red cell transfusion. Other clinical characteristics are also predictive, though to a lesser extent.
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http://dx.doi.org/10.1111/vox.12831DOI Listing
November 2019

Platelet and red cell transfusions for neonates: lifesavers or Trojan horses?

Expert Rev Hematol 2019 10 29;12(10):797-800. Epub 2019 Aug 29.

Department of Pediatrics, Division of neonatology, Leiden University Medical Center , Leiden , the Netherlands.

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http://dx.doi.org/10.1080/17474086.2019.1657824DOI Listing
October 2019

Transition from fresh frozen plasma to solvent/detergent plasma in the Netherlands: comparing clinical use and transfusion reaction risks.

Haematologica 2020 04 4;105(4):1158-1165. Epub 2019 Jul 4.

Jon J. van Rood Centre for Clinical Transfusion Research, Sanquin Research, Leiden

Plasma transfusion is indicated for replenishment of coagulative proteins to stop or prevent bleeding. In 2014, the Netherlands switched from using ~300mL fresh frozen plasma (FFP) units to using 200mL Omniplasma, a solvent/detergent treated pooled plasma (SD plasma), units. We evaluated the effect of the introduction of SD plasma on clinical plasma use, associated bleeding, and transfusion reaction incidences. Using diagnostic data from six Dutch hospitals, national blood bank data, and national hemovigilance data for 2011 to 2017, we compared the plasma/red blood cell (RBC) units ratio (f) and the mean number of plasma and RBC units transfused for FFP (~300mL) and SD plasma (200mL) for various patient groups, and calculated odds ratios comparing their associated transfusion reaction risks. Analyzing 13,910 transfusion episodes, the difference (Δf = f f) in mean plasma/RBC ratio (f) was negligible (Δf = 0.01 [95% confidence interval (CI): -0.02 - 0.05]; =0.48). SD plasma was associated with fewer RBC units transfused per episode in gynecological (difference of mean number of units -1.66 [95% CI: -2.72, -0.61]) and aneurysm (-0.97 [-1.59, -0.35]) patients. SD plasma was further associated with fewer anaphylactic reactions than FFP (odds ratio 0.37 [0.18, 0.77; <0.01]) while the differences for most transfusion reactions were not statistically significant. SD plasma units, despite being one third smaller in volume than FFP units, are not associated with a higher plasma/RBC ratio. SD plasma is associated with fewer anaphylactic reactions than FFP plasma/RBC units ratio.
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http://dx.doi.org/10.3324/haematol.2019.222083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7109716PMC
April 2020

Comparison of outcome between intrauterine balloon tamponade and uterine artery embolization in the management of persistent postpartum hemorrhage: A propensity score-matched cohort study.

Acta Obstet Gynecol Scand 2019 11 10;98(11):1473-1482. Epub 2019 Jul 10.

Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands.

Introduction: The aim of this study was to compare the outcomes of women who were initially managed by intrauterine balloon tamponade or uterine artery embolization because of persistent postpartum hemorrhage demanding an immediate intervention to control bleeding.

Material And Methods: Propensity score-matched cohort study including women who had intrauterine balloon tamponade or uterine artery embolization as initial management strategy to control persistent postpartum hemorrhage, that is, refractory to first-line therapy combined with at least one uterotonic agent. The primary outcome measure was a composite of peripartum hysterectomy and/or maternal mortality. Secondary outcomes measures were total volume of blood loss and total number of packed red blood cells transfused.

Results: Our 1:1 propensity score-matched cohort comprised of 50 women who had intrauterine balloon tamponade and 50 women who underwent uterine artery embolization at a blood loss between 1000 and 7000 mL. There was no statistically significant difference in the hysterectomy risk between the two groups (n = 6 in each group, odds ratio [OR] 1.00, 95% confidence interval [CI] .30-3.34), in total volume of blood loss (median 4500 mL, interquartile range [IQR] 3600-5400) for balloon vs 4000 mL (IQR 3250-5000) for embolization, P = 0.382) or in total units of packed red blood cells transfused (median 7 (IQR 5-10) for balloon vs 6 [IQR 4-9] for embolization, P = 0.319). Fifteen women (30%) who were initially managed by an intrauterine balloon still underwent uterine artery embolization, of whom one had an embolization-related thrombo-embolic event. Maternal mortality occurred in neither of the intervention groups.

Conclusions: No difference in the risk of peripartum hysterectomy and/or maternal death was observed between women who had intrauterine balloon tamponade and women who underwent uterine artery embolization as an initial management for persistent postpartum hemorrhage. Although this study was underpowered to demonstrate equivalence, our study design provides a framework for future research in which intrauterine balloon tamponade may prove to be a suitable intervention of first choice in the management of persistent postpartum hemorrhage.
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http://dx.doi.org/10.1111/aogs.13679DOI Listing
November 2019

[Anaemia in hospital patients: transfusion or not?]

Ned Tijdschr Geneeskd 2019 05 22;163. Epub 2019 May 22.

LUMC, afd. Klinische Epidemiologie, Leiden.

Increasingly restrictive red blood cell transfusion strategies have led to growing numbers of patients being discharged from hospital with moderate anaemia, and doubts about the effects of this trend on the outcomes of patients with anaemia are growing. One advantage of doubts is that they lead to variation in practice, which, in theory, allows the study of routinely collected data on the effects of an intervention (transfusion) on patient-relevant outcomes. To do this in a reliable way, we need solid data on outcomes and on all the potentially relevant clinical characteristics that are associated with both the decision to transfuse and the outcomes. Currently, such data are not available. As part of routine practice, clinicians should be encouraged to document the arguments for their treatment decisions and the intended outcomes. This will allow learning from daily practice in the field of transfusion medicine and in other health care disciplines.
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May 2019

Predicting anaemia and transfusion dependency in severe alloimmune haemolytic disease of the fetus and newborn in the first 3 months after birth.

Br J Haematol 2019 08 29;186(4):565-573. Epub 2019 May 29.

Department of Paediatrics, Division of Neonatology, Leiden University Medical Centre, Leiden, the Netherlands.

Infants with haemolytic disease of the fetus and newborn (HDFN) often require erythrocyte transfusions in the first 3 months of life. We aimed to evaluate the incidence, timing and potential predictors of transfusion-dependent anaemia. An observational cohort of 298 term and near-term infants with severe HDFN treated with or without intrauterine transfusion (IUT) was evaluated. Transfusions were administered to 88% (169/193) of infants with IUT and 60% (63/105) without IUT. The following potential predictors were associated with less anaemia: K compared to D immunisation [odds ratio (OR) 0·13, 95% confidence interval (CI): 0·03-0·55], higher reticulocyte count at birth [per 10 parts per thousand (‰) higher, OR 0·99, CI: 0·97-1·00] and exchange transfusion (OR 0·11, 95% CI: 0·03-0·50). Without IUT, these variables were: lower reticulocyte count at birth (per 10‰ lower, OR 1·02, 95% CI: 1·00-1·03), lower maximum bilirubin after birth (per 10 μmol/l lower, OR 1·01, 95% CI: 1·01-1·02) and exchange transfusion (OR 0·07, 95% CI: 0·01-0·20). In conclusion, potential predictors for anaemia in infants with severe HDFN varied between infants treated with and without IUT and are useful for selecting subgroups of infants at increased risk of anaemia.
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http://dx.doi.org/10.1111/bjh.15962DOI Listing
August 2019

Predictive value of a bleeding score for postpartum hemorrhage.

Res Pract Thromb Haemost 2019 Apr 4;3(2):277-284. Epub 2019 Apr 4.

Centre for Clinical Transfusion Research Sanquin Research Leiden The Netherlands.

Background: A reliable screening tool that could contribute to the identification of women with an increased risk of postpartum hemorrhage would be of great clinical significance.

Objectives: The aim of this study was to examine the added predictive value of a bleeding assessment tool for postpartum hemorrhage exceeding 1000 mL.

Patients/methods: Prospective two-center cohort study among 1147 pregnant women visiting the outpatient clinic or the maternity ward who completed a bleeding assessment tool prior to birth. The condensed MCMDM-1VWD bleeding assessment tool was adjusted to a questionnaire that could be used as a self-assessment bleeding tool. A score of ≥4 was considered to be abnormal.

Results: In the 1147 pregnant women in our cohort, bleeding scores ranged from -3 to 13, with a median of 1 (IQR -1 to 3); 197 (17%) women developed postpartum hemorrhage. Among women with a history of postpartum hemorrhage 29% developed postpartum hemorrhage. Among 147 women with an abnormal bleeding score (≥4), 27 (18%) developed postpartum hemorrhage, whereas the remaining 170 cases of postpartum hemorrhage had a normal bleeding score. Despite the high incidence of postpartum hemorrhage, the ability of the bleeding score to predict postpartum hemorrhage was poor: area under receiver operating curve 0.53 (95% CI 0.49-0.58) for postpartum hemorrhage (PPH) ≥1000 mL.

Conclusions: A history of significant postpartum hemorrhage was associated with an increased risk of subsequent postpartum hemorrhage. However, screening with a bleeding assessment tool did not help to discriminate women who will develop postpartum hemorrhage from women who will not.
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http://dx.doi.org/10.1002/rth2.12194DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6462748PMC
April 2019