Publications by authors named "Ann-Charlotte Laska"

27 Publications

  • Page 1 of 1

Outcomes in Antiplatelet-Associated Intracerebral Hemorrhage in the TICH-2 Randomized Controlled Trial.

J Am Heart Assoc 2021 Feb 15;10(5):e019130. Epub 2021 Feb 15.

Stroke Trials Unit Division of Clinical Neuroscience University of Nottingham United Kingdom.

Background Antiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain. Methods and Results This is an exploratory analysis of the TICH-2 (Tranexamic Acid in Intracerebral Hemorrhage-2) double-blind, randomized, placebo-controlled trial, which studied the efficacy of tranexamic acid in patients with spontaneous ICH within 8 hours of onset. Multivariable logistic regression and ordinal regression were performed to explore the relationship between pre-ICH antiplatelet therapy, and 24-hour hematoma expansion and day 90 modified Rankin Scale score, as well as the effect of tranexamic acid. Of 2325 patients, 611 (26.3%) had pre-ICH antiplatelet therapy. They were older (mean age, 75.7 versus 66.5 years), more likely to have ischemic heart disease (25.4% versus 2.7%), ischemic stroke (36.2% versus 6.3%), intraventricular hemorrhage (40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6 mL) than the no-antiplatelet group. Pre-ICH antiplatelet therapy was associated with a significantly increased risk of hematoma expansion (adjusted odds ratio [OR], 1.28; 95% CI, 1.01-1.63), a shift toward unfavorable outcome in modified Rankin Scale (adjusted common OR, 1.58; 95% CI, 1.32-1.91) and a higher risk of death at day 90 (adjusted OR, 1.63; 95% CI, 1.25-2.11). Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62-0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41-0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248). Conclusions Antiplatelet therapy is independently associated with hematoma expansion and unfavorable functional outcome. Tranexamic acid reduced hematoma expansion regardless of prior antiplatelet therapy use. Registration URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.
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http://dx.doi.org/10.1161/JAHA.120.019130DOI Listing
February 2021

High Thrombin Generation after Acute Ischemic Stroke or Transient Ischemic Attack Is Associated with a Reduced Risk of Recurrence: An Observational Cohort Study.

Thromb Haemost 2020 Dec 12. Epub 2020 Dec 12.

Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden.

Thrombin is increasingly recognized to be of importance for cardiovascular disease. The aim of this study was to investigate the prognostic value of thrombin generation variables in a cohort of patients with acute ischemic stroke (AIS) or transient ischemic attack (TIA). Thrombin generation potential measured by calibrated automated thrombogram (CAT) and prothrombin fragment F1 + 2 was determined in the acute and convalescent phases for a cohort of 190 patients with AIS/TIA. Microvesicle (MV)-induced thrombin generation potential was determined for a subset of patients using modified CAT. Primary outcome was a composite of fatal and nonfatal AIS or myocardial infarction as documented in Swedish registers during a total follow-up of 986 patient-years. Hazard ratios (HRs) were calculated using Cox regression based on variable median split. Peak thrombin and endogenous thrombin potential (ETP) above median in the acute phase were associated with a reduced risk of primary outcome after adjustment for cardiovascular risk factors, HR: 0.50 (0.27-0.92),  = 0.026 and HR: 0.53 (0.28-0.99),  = 0.048, respectively. F1 + 2 was lower in patients than in healthy controls but not associated with outcome. MV-induced peak thrombin above median in the acute phase was associated with recurrent AIS, unadjusted HR: 2.65 (1.03-6.44),  = 0.044. Contrary to expectation, high thrombin generation potential is associated with a reduced risk of recurrent ischemic event in patients with AIS/TIA. Low ETP/peak thrombin combined with high MV-induced peak thrombin can potentially identify patients at high risk of recurrence.
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http://dx.doi.org/10.1055/s-0040-1721146DOI Listing
December 2020

Validation of the Simplified Modified Rankin Scale Questionnaire.

Eur Neurol 2020 7;83(5):493-499. Epub 2020 Oct 7.

Department of Neuroscience, Neurology, Uppsala University, Akademiska sjukhuset, Uppsala, Sweden.

Introduction: The modified Rankin scale (mRS) is the most common assessment tool for measuring overall functional outcome in stroke studies. The traditional way of using mRS face-to-face is time- and cost-consuming. The aim of this study was to test the validity of the Swedish translation of the simplified modified Rankin scale questionnaire (smRSq) as compared with the mRS assessed face-to-face 6 months after a stroke.

Methods: Within the ongoing EFFECTS trial, smRSq was sent out to 108 consecutive stroke patients 6 months after a stroke. The majority, 90% (97/108), of the patients answered the questionnaire; for the remaining 10%, it was answered by the next of kin. The patients were assessed by face-to-face mRS by 7 certified healthcare professionals at 4 Swedish stroke centres. The primary outcome was assessed by Cohen's kappa and weighted kappa.

Results: There was good agreement between postal smRSq, answered by the patients, and the mRS face-to-face; Cohen's kappa was 0.43 (CI 95% 0.31-0.55), weighted kappa was 0.64 (CI 95% 0.55-0.73), and Spearman rank correlation was 0.82 (p < 0.0001). In 55% (59/108), there was full agreement, and of the 49 patients not showing exact agreement, 44 patients differed by 1 grade and 5 patients had a difference of 2 grades.

Discussion/conclusion: Our results show good validity of the postal smRSq, answered by the patients, compared with the mRS carried out face-to-face at 6 months after a stroke. This result could help trialists in the future simplify study design and make multicentre trials and quality registers with a large number of patients more feasible and time-saving.
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http://dx.doi.org/10.1159/000510721DOI Listing
October 2020

Perceived Quality of Care Transitions between Hospital and the Home in People with Stroke.

J Am Med Dir Assoc 2020 Dec 29;21(12):1885-1892. Epub 2020 Jul 29.

Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Karolinska University Hospital, Stockholm, Sweden.

Objectives: To explore the perceived quality of care transitions from hospital to the home with referral to subsequent rehabilitation in the home, and factors associated with low perceived quality, in people with stroke.

Design: Observational study.

Setting And Participants: Eligible were patients with a suspected acute stroke admitted to 1 of 4 inpatient hospital units in the Stockholm region and discharged home with referral to a neurorehabilitation team in primary care.

Methods: Data on perceived quality of care transition was collected with the Care Transition Measure (CTM-15) 1 week after discharge. Additional data were mainly retrieved from medical records. To analyze difference in mean total score of the CTM-15 between participants' characteristics, length of hospital stay, disease-related data, and functioning, the Mann-Whitney U test and independent sample t test were used for dichotomized variables and 1-way analysis of variance and the Tukey post hoc test for variables with more than 2 groups. To analyze differences between participants with low and high perceived quality per item, univariable regression analyses were performed. Thereafter, multivariable regression models were created to explore associations between low perceived quality and the independent variables.

Results: Mean age of the 189 participants was 75 years and 91% had a mild or very mild stroke. The majority perceived most areas of the care transition to be of high quality. Nevertheless, several areas for improvement were identified. People with a more severe stroke perceived the quality of the care transition to be lower in comparison with those with a mild stroke. The association was weak between patient or clinical characteristics and the perceived quality.

Conclusion And Implications: Our findings suggest that preparation for discharge and information and support for self-management postdischarge should be enhanced in the referral-based care transition after stroke. Special attention should be given to people with severe stroke.
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http://dx.doi.org/10.1016/j.jamda.2020.06.042DOI Listing
December 2020

Stroke survivors' priorities for research related to life after stroke.

Top Stroke Rehabil 2021 Mar 5;28(2):153-158. Epub 2020 Jul 5.

Department of Neuroscience, Neurology, Uppsala University , Uppsala, Sweden.

Background: Stroke has transitioned from an untreatable, unpreventable disease to a highly treatable and preventable disease over recent decades, and the number of stroke survivors is expected to increase. The number is also foreseen to grow larger as a result of an aging population. With an escalating number of stroke survivors, research on how to improve life after stroke is needed.

Aims: The primary aim was to determine which area of research related to life after stroke that stroke patients and their informal carers prioritized as being relevant and valuable.

Methods: A cross-sectional study of all patients who had completed the 12 months of follow-up in the EFFECTS trial. In the questionnaire the stroke patients and their informal carers were asked to prioritize areas of research they considered important and valuable with respect to their life after stroke.

Results: Of the 731 patients who were still alive after the 12 months-follow-up, 589 responded. The most prioritized areas of research were (290 (49%) responders) and (173 (29%) responders). Women answered the undefined alternative "" more often than men (43 women (11%) versus 11 men (6%), = .04). Younger patients prioritized to a higher extent (88 (45%) versus (22%), < .001), and elderly prioritized (214 (54%) versus 76 (40%), = .002) and (38 (10%) versus 9 (5%), = .045).

Conclusions: Life after stroke is perceived differentely with aging. Future research should address strategies to face challenges such as imbalance and walking difficulties and post-stroke-fatigue.
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http://dx.doi.org/10.1080/10749357.2020.1789829DOI Listing
March 2021

Implementation of a Prehospital Stroke Triage System Using Symptom Severity and Teleconsultation in the Stockholm Stroke Triage Study.

JAMA Neurol 2020 06;77(6):691-699

Department of Neurology, Karolinska University Hospital, Stockholm, Sweden.

Importance: To our knowledge, it is unknown whether a prehospital stroke triage system combining symptom severity and teleconsultation could accurately select patients for primary stroke center bypass and hasten delivery of endovascular thrombectomy (EVT) without delaying intravenous thrombolysis (IVT).

Objective: To evaluate the predictive performance of the newly implemented Stockholm Stroke Triage System (SSTS) for large-artery occlusion (LAO) stroke and EVT initiation. Secondary objectives included evaluating whether the Stockholm Stroke Triage System shortened onset-to-puncture time for EVT and onset-to-needle time (ONT) for IVT.

Design, Setting, And Participants: This population-based prospective cohort study conducted from October 2017 to October 2018 across the Stockholm region (Sweden) included patients transported by first-priority ("code stroke") ambulance to the hospital for acute stroke suspected by an ambulance nurse and historical controls (October 2016-October 2017). Exclusion criteria were in-hospital stroke and helicopter or private transport. Of 2909 eligible patients, 4 (0.14%) declined participation.

Exposures: Patients were assessed by ambulance nurses with positive the face-arm-speech-time test or other stroke suspicion and were evaluated for moderate-to-severe hemiparesis (≥2 National Institutes of Health stroke scale points each on the ipsilateral arm and leg [A2L2 test]). If present, the comprehensive stroke center (CSC) stroke physician was teleconsulted by phone for confirmation of stroke suspicion, assessment of EVT eligibility, and direction to CSC or the nearest primary stroke center. If absent, the nearest hospital was prenotified.

Main Outcomes And Measures: Primary outcome: LAO stroke. Secondary outcomes: EVT initiation, onset-to-puncture time, and ONT. Predictive performance measures included sensitivity, specificity, positive and negative predictive values, the overall accuracy for LAO stroke, and EVT initiation.

Results: We recorded 2905 patients with code-stroke transports (1420 women [49%]), and of these, 323 (11%) had A2L2+ teleconsultation positive results and were triaged for direct transport to CSC (median age, 73 years [interquartile range (IQR), 64-82 years]; 55 women [48%]). Accuracy for LAO stroke was 87% (positive predictive value, 41%; negative predictive value, 93%) and 91% for EVT initiation (positive predictive value, 26%; negative predictive value, 99%). Endovascular thrombectomy was performed for 84 of 323 patients (26%) with triage-positive results and 35 of 2582 patients (1.4%) with triage-negative results. In EVT cases with a known onset time (77 [3%]), the median OPT was 137 minutes (IQR, 118-180; previous year, 206 minutes [IQR, 160-280]; n = 75) (P < .001). The regional median ONT (337 [12%]) was unchanged at 115 minutes (IQR, 83-164; previous year, 115 minutes [IQR, 85-161]; n = 360) (P = .79). The median CSC IVT door-to-needle time was 13 minutes (IQR, 10-18; 116 [4%]) (previous year, 31 minutes [IQR, 19-38]; n = 45) (P < .001).

Conclusions And Relevance: The Stockholm Stroke Triage System, which combines symptom severity and teleconsultation, results in markedly faster EVT delivery without delaying IVT.
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http://dx.doi.org/10.1001/jamaneurol.2020.0319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7136864PMC
June 2020

Prognostic Value of Circulating Microvesicle Subpopulations in Ischemic Stroke and TIA.

Transl Stroke Res 2020 08 25;11(4):708-719. Epub 2020 Jan 25.

Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.

Platelet microvesicles (PMV) have previously been found elevated in acute ischemic stroke (IS) and could be biomarkers for risk of recurrence. PMV surface antigens such as P-selectin and phosphatidylserine (PS) reflect platelet activation and procoagulance. Tissue factor-positive microvesicles (TFMV) are considered procoagulant, in particular if co-expressing PS. We enumerated MV subpopulations with these surface antigens in a cohort of 211 patients with primarily non-cardioembolic IS or transient ischemic attack (TIA) and investigated their association with long-term outcome. MV concentrations were determined by flow cytometry in the acute and convalescent phase. Primary outcome was a composite of fatal and non-fatal recurrent IS or myocardial infarction. Secondary outcomes were recurrent IS and all-cause mortality. Outcome events were obtained from Swedish registers during a follow-up of 1100 patient years. Concentrations of PS-positive and PS-negative MV populations were elevated in patients compared with healthy controls in both the acute and convalescent phase. PSTFPMV displayed pronounced elevations, median fold change 77 in the acute phase (p < 0.0001) but were not associated with outcome, neither were PSP-selectinPMV. The only subpopulation positively associated with primary outcome was PSTFPMV, with adjusted hazard ratio of 1.86 (1.04-3.31, p = 0.036) by Cox regression. Unexpectedly, several MV subpopulations tended to be associated with reduced risk of poor long-term outcome. Our results suggest that PSTFPMV may be a promising marker for cerebral ischemia, and that the in vivo generation of PSMV after IS/TIA warrants further study. Future MV studies should ideally enumerate PS and PSMV subpopulations separately.
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http://dx.doi.org/10.1007/s12975-019-00777-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340656PMC
August 2020

Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel.

Trials 2019 Oct 30;20(1):618. Epub 2019 Oct 30.

Department of Clinical Neuroscience, Neurology, Uppsala University, SE-751 85, Uppsala, Sweden.

Background: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT.

Methods: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively.

Results: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%).

Conclusions: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.

Trial Registration: The protocol for this study was registered at the Northern Ireland Hub for trials methodology research (SWAT ID 64 ). The EFFECTS study has EudraCT number 2011-006130-16 and was registered 17 February 2016 at ClinicalTrials.gov number NCT02683213 .
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http://dx.doi.org/10.1186/s13063-019-3737-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6822437PMC
October 2019

Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT.

Health Technol Assess 2019 07;23(35):1-48

Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.

Background: Tranexamic acid reduces death due to bleeding after trauma and postpartum haemorrhage.

Objective: The aim of the study was to assess if tranexamic acid is safe, reduces haematoma expansion and improves outcomes in adults with spontaneous intracerebral haemorrhage (ICH).

Design: The TICH-2 (Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage) study was a pragmatic, Phase III, prospective, double-blind, randomised placebo-controlled trial.

Setting: Acute stroke services at 124 hospitals in 12 countries (Denmark, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey and the UK).

Participants: Adult patients (aged ≥ 18 years) with ICH within 8 hours of onset.

Exclusion Criteria: Exclusion criteria were ICH secondary to anticoagulation, thrombolysis, trauma or a known underlying structural abnormality; patients for whom tranexamic acid was thought to be contraindicated; prestroke dependence (i.e. patients with a modified Rankin Scale [mRS] score > 4); life expectancy < 3 months; and a Glasgow Coma Scale score of < 5.

Interventions: Participants, allocated by randomisation, received 1 g of an intravenous tranexamic acid bolus followed by an 8-hour 1-g infusion or matching placebo (i.e. 0.9% saline).

Main Outcome Measure: The primary outcome was functional status (death or dependency) at day 90, which was measured by the shift in the mRS score, using ordinal logistic regression, with adjustment for stratification and minimisation criteria.

Results: A total of 2325 participants (tranexamic acid,  = 1161; placebo,  = 1164) were recruited from 124 hospitals in 12 countries between 2013 and 2017. Treatment groups were well balanced at baseline. The primary outcome was determined for 2307 participants (tranexamic acid,  = 1152; placebo,  = 1155). There was no statistically significant difference between the treatment groups for the primary outcome of functional status at day 90 [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.76 to 1.03;  = 0.11]. Although there were fewer deaths by day 7 in the tranexamic acid group (aOR 0.73, 95% CI 0.53 to 0.99;  = 0.041), there was no difference in case fatality at 90 days (adjusted hazard ratio 0.92, 95% CI 0.77 to 1.10;  = 0.37). Fewer patients experienced serious adverse events (SAEs) after treatment with tranexamic acid than with placebo by days 2 ( = 0.027), 7 ( = 0.020) and 90 ( = 0.039). There was no increase in thromboembolic events or seizures.

Limitations: Despite attempts to enrol patients rapidly, the majority of participants were enrolled and treated > 4.5 hours after stroke onset. Pragmatic inclusion criteria led to a heterogeneous population of participants, some of whom had very large strokes. Although 12 countries enrolled participants, the majority (82.1%) were from the UK.

Conclusions: Tranexamic acid did not affect a patient's functional status at 90 days after ICH, despite there being significant modest reductions in early death (by 7 days), haematoma expansion and SAEs, which is consistent with an antifibrinolytic effect. Tranexamic acid was safe, with no increase in thromboembolic events.

Future Work: Future work should focus on enrolling and treating patients early after stroke and identify which participants are most likely to benefit from haemostatic therapy. Large randomised trials are needed.

Trial Registration: Current Controlled Trials ISRCTN93732214.

Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 35. See the NIHR Journals Library website for further project information. The project was also funded by the Pragmatic Trials, UK, funding call and the Swiss Heart Foundation in Switzerland.
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http://dx.doi.org/10.3310/hta23350DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6680370PMC
July 2019

A core outcome set for aphasia treatment research: The ROMA consensus statement.

Int J Stroke 2019 02 10;14(2):180-185. Epub 2018 Oct 10.

21 School of Education, Communication and Language Sciences, Newcastle University, Newcastle Upon Tyne, UK.

Background: A core outcome set (COS; an agreed, minimum set of outcomes) was needed to address the heterogeneous measurement of outcomes in aphasia treatment research and to facilitate the production of transparent, meaningful, and efficient outcome data.

Objective: The Research Outcome Measurement in Aphasia (ROMA) consensus statement provides evidence-based recommendations for the measurement of outcomes for adults with post-stroke aphasia within phases I-IV aphasia treatment studies.

Methods: This statement was informed by a four-year program of research, which comprised investigation of stakeholder-important outcomes using consensus processes, a scoping review of aphasia outcome measurement instruments, and an international consensus meeting. This paper provides an overview of this process and presents the results and recommendations arising from the international consensus meeting.

Results: Five essential outcome constructs were identified: Language, communication, patient-reported satisfaction with treatment and impact of treatment, emotional wellbeing, and quality of life. Consensus was reached for the following measurement instruments: Language: The Western Aphasia Battery Revised (WAB-R) (74% consensus); emotional wellbeing: General Health Questionnaire (GHQ)-12 (83% consensus); quality of life: Stroke and Aphasia Quality of Life Scale (SAQOL-39) (96% consensus). Consensus was unable to be reached for measures of communication (where multiple measures exist) or patient-reported satisfaction with treatment or impact of treatment (where no measures exist).

Discussion: Harmonization of the ROMA COS with other core outcome initiatives in stroke rehabilitation is discussed. Ongoing research and consensus processes are outlined.

Conclusion: The WAB-R, GHQ-12, and SAQOL-39 are recommended to be routinely included within phases I-IV aphasia treatment studies. This consensus statement has been endorsed by the Collaboration of Aphasia Trialists, the British Aphasiology Society, the German Society for Aphasia Research and Therapy, and the Royal College of Speech Language Therapists.
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http://dx.doi.org/10.1177/1747493018806200DOI Listing
February 2019

Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial.

Lancet 2018 05 16;391(10135):2107-2115. Epub 2018 May 16.

Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK; Stroke, Nottingham University Hospitals NHS Trust, City Hospital Campus, Nottingham, UK.

Background: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage.

Methods: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset. Randomisation was done centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214.

Findings: We recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0·88, 95% CI 0·76-1·03, p=0·11). Although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0·73, 0·53-0·99, p=0·0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0·92, 95% CI 0·77-1·10, p=0·37). Fewer patients had serious adverse events after tranexamic acid than after placebo by days 2 (379 [33%] patients vs 417 [36%] patients), 7 (456 [39%] vs 497 [43%]), and 90 (521 [45%] vs 556 [48%]).

Interpretation: Functional status 90 days after intracerebral haemorrhage did not differ significantly between patients who received tranexamic acid and those who received placebo, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect.

Funding: National Institute of Health Research Health Technology Assessment Programme and Swiss Heart Foundation.
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http://dx.doi.org/10.1016/S0140-6736(18)31033-XDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5976950PMC
May 2018

Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

Trials 2018 Jan 8;19(1):14. Epub 2018 Jan 8.

Centre for Safety Research, KTH Royal Institute of Technology, 100 44, Stockholm, Sweden.

Background: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT.

Methods: ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT.

Discussion: EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.

Trial Registrations: The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.
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http://dx.doi.org/10.1186/s13063-017-2367-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5759750PMC
January 2018

Route of Feeding as a Proxy for Dysphagia After Stroke and the Effect of Transdermal Glyceryl Trinitrate: Data from the Efficacy of Nitric Oxide in Stroke Randomised Controlled Trial.

Transl Stroke Res 2018 04 2;9(2):120-129. Epub 2017 Aug 2.

Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK.

Post-stroke dysphagia is common, associated with poor outcome and often requires non-oral feeding/fluids. The relationship between route of feeding and outcome, as well as treatment with glyceryl trinitrate (GTN), was studied prospectively. The Efficacy of Nitric Oxide in Stroke (ENOS) trial assessed transdermal GTN (5 mg versus none for 7 days) in 4011 patients with acute stroke and high blood pressure. Feeding route (oral = normal or soft diet; non-oral = nasogastric tube, percutaneous endoscopic gastrostomy tube, parenteral fluids, no fluids) was assessed at baseline and day 7. The primary outcome was the modified Rankin Scale (mRS) measured at day 90. At baseline, 1331 (33.2%) patients had non-oral feeding, were older, had more severe stroke and more were female, than 2680 (66.8%) patients with oral feeding. By day 7, 756 patients had improved from non-oral to oral feeding, and 119 had deteriorated. Non-oral feeding at baseline was associated with more impairment at day 7 (Scandinavian Stroke Scale 29.0 versus 43.7; 2p < 0.001), and worse mRS (4.0 versus 2.7; 2p < 0.001) and death (23.6 versus 6.8%; 2p = 0.014) at day 90. Although GTN did not modify route of feeding overall, randomisation ≤6 h of stroke was associated with a move to more oral feeding at day 7 (odds ratio = 0.61, 95% confidence intervals 0.38, 0.98; 2p = 0.040). As a proxy for dysphagia, non-oral feeding is present in 33% of patients with acute stroke and associated with more impairment, dependency and death. GTN moved feeding route towards oral intake if given very early after stroke. Clinical Trial Registration Clinical Trial Registration-URL: http://www.controlled-trials.com . Unique identifier: ISRCTN99414122.
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http://dx.doi.org/10.1007/s12975-017-0548-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5849635PMC
April 2018

Infections Up to 76 Days After Stroke Increase Disability and Death.

Transl Stroke Res 2017 12 27;8(6):541-548. Epub 2017 Jul 27.

School of Life Sciences, University of Nottingham, Nottingham, UK.

Early infection after stroke is associated with a poor outcome. We aimed to determine whether delayed infections (up to 76 days post-stroke) are associated with poor outcome at 90 days. Data came from the international Efficacy of Nitric Oxide Stroke (ENOS, ISRCTN99414122) trial. Post hoc data on infections were obtained from serious adverse events reports between 1 and 76 days following stroke in this large cohort of patients. Regression models accounting for baseline covariates were used to analyse fatalities and functional outcomes (modified Rankin Scale (mRS), Barthel Index, Euro-Qol-5D) at 90 days, in patients with infection compared to those without infection. Of 4011 patients, 242 (6.0%) developed one or more serious infections. Infections were associated with an increased risk of death (p < 0.001) and an increased likelihood of dependency (measured by mRS) compared to those of all other patients (p < 0.001). This remained when only surviving patients were analysed, indicating that the worsening of functional outcome is not due to mortality (p < 0.001). In addition, the timing of the infection after stroke did not alter its detrimental association with fatality (p = 0.14) or functional outcome (p = 0.47). In conclusion, severe post-stroke infections, whether occurring early or late after stroke, are associated with an increased risk of death and poorer functional outcome, independent of differences in baseline characteristics or treatment. Not only are strategies needed for reducing the risk of infection immediately after stroke, but also during the first 3 months following a stroke. This study is registered: ISRCTN registry, number ISRCTN99414122, ClinicalTrials.gov Identifier, NCT00989716.
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http://dx.doi.org/10.1007/s12975-017-0553-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818141PMC
December 2017

[Encefalopathy as a side effect of metronidazole therapy – a case report].

Lakartidningen 2017 03 20;114. Epub 2017 Mar 20.

Strokeenh, Medicinkliniken, Danderyds sjh - Stockholm, Sweden.

Encefalopathy as a side effect of metronidazole therapy - a case report  Neurological symptoms as side effects of pharmacological treatment generally tend to remain underdiagnosed. In this report, we present a case of a 79 year old patient that developed encephalopathy whilst undergoing prophylactic treatment with Metronidazole. The initial presentation of disseminated neurological symptoms lead to the suspicion of a cerebrovascular lesion. However, exacerbation of symptomatology with gait disturbance, ataxia and dysarthria challenged the preliminary diagnosis. Brain magnetic resonance imaging (MRI) demonstrated T2 hyper-intensity over bilateral dentate nuclei. A drug history revealed that the patient had been treated with Metronidazole daily for several weeks due to a surgical condition. Cessation of the drug provided reversal of symptoms and radiological findings upon follow up MRI. This case report aims at increasing awareness regarding side effects of Metronidazole as well as early detection in patients who present with neurological symptoms.
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March 2017

Validation of an enzyme-linked immunosorbent assay for the quantification of citrullinated histone H3 as a marker for neutrophil extracellular traps in human plasma.

Immunol Res 2017 06;65(3):706-712

Department of Clinical Sciences, Danderyd Hospital, Division of Internal Medicine, Karolinska Institutet, Stockholm, Sweden.

There is an emerging interest in the diverse functions of neutrophil extracellular traps (NETs) in a variety of disease settings. However, data on circulating NETs rely largely upon surrogate NET markers such as cell-free DNA, nucleosomes, and NET-associated enzymes. Citrullination of histone H3 by peptidyl arginine deiminase 4 (PAD4) is central for NET formation, and citrullinated histone H3 (H3Cit) is considered a NET-specific biomarker. We therefore aimed to optimize and validate a new enzyme-linked immunosorbent assay (ELISA) to quantify the levels of H3Cit in human plasma. A standard curve made of in vitro PAD4-citrullinated histones H3 allows for the quantification of H3Cit in plasma using an anti-histone antibody as capture antibody and an anti-histone H3 citrulline antibody for detection. The assay was evaluated for linearity, stability, specificity, and precision on plasma samples obtained from a human model of inflammation before and after lipopolysaccharide injection. The results revealed linearity and high specificity demonstrated by the inability of detecting non-citrullinated histone H3. Coefficients of variation for intra- and inter-assay variability ranged from 2.1 to 5.1% and from 5.8 to 13.5%, respectively, allowing for a high precision. Furthermore, our results support an inflammatory induction of a systemic NET burden by showing, for the first time, clear intra-individual elevations of plasma H3Cit in a human model of lipopolysaccharide-induced inflammation. Taken together, our work demonstrates the development of a new method for the quantification of H3Cit by ELISA that can reliably be used for the detection of NETs in human plasma.
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http://dx.doi.org/10.1007/s12026-017-8905-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5440486PMC
June 2017

Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: Protocol for a randomized, placebo-controlled trial.

Int J Stroke 2016 08 5;11(6):683-94. Epub 2016 Apr 5.

Stroke, Division of Clinical Neuroscience, Nottingham, UK.

Rationale: Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions.

Aim: This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontaneous intracerebral hemorrhage reduces death or dependency.

Design: Phase III prospective double-blind randomized placebo-controlled trial. Participants within 8 h of spontaneous intracerebral hemorrhage are randomized to receive either intravenous tranexamic acid 1 g 10 min bolus followed by 1 g 8 h infusion, or placebo.

Sample Size Estimates: A trial of 2000 participants (300 from start-up phase and 1700 from main phase) will have 90% power to detect an ordinal shift of the modified Rankin Scale with odds ratio 0.79.

Study Outcomes: The primary outcome is death or dependency measured by ordinal shift analysis of the 7 level mRS at day 90. Secondary outcomes are neurological impairment at day 7 and disability, quality of life, cognition, and mood at day 90. Safety outcomes are death, serious adverse events, thromboembolic events, and seizures. Cost outcomes are length of stay in hospital, readmission, and institutionalization.

Discussion: This pragmatic trial is assessing efficacy of tranexamic acid after spontaneous intracerebral hemorrhage. Recruitment started in 2013; as of 15th January 2016 1355 participants have been enrolled, from 95 centers in seven countries. Recruitment is due to end in 2017. TICH-2 Trial is registered as ISRCTN93732214.
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http://dx.doi.org/10.1177/1747493016641960DOI Listing
August 2016

NETosis promotes cancer-associated arterial microthrombosis presenting as ischemic stroke with troponin elevation.

Thromb Res 2016 Mar 12;139:56-64. Epub 2016 Jan 12.

Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Karolinska Institutet, Stockholm, Sweden.

Introduction: Large elevations of high sensitive Troponin T (hsTnT) in ischemic stroke patients is associated with a poor outcome. In a pilot study we found a high prevalence of malignancies among these patients. Since neutrophil extracellular traps (NETs) have been linked to cancer-associated thrombosis, we hypothesized that the concomitant cerebral and myocardial ischemia could be the result of a NET-induced hypercoagulable state.

Materials And Methods: Clinical assessments, plasma analyses and autopsies with histopathology (in cases of in-hospital mortality) were performed on ischemic stroke patients with high elevations of hsTnT (N=12) and normal hsTnT (N=19).

Results: Patients with hsTnT elevation had an unexpectedly higher prevalence of cancer (p=0.002), half of which were diagnosed post-mortem. Autopsies of these patients revealed widespread myocardial, cerebral and pulmonary microthrombosis with H3Cit in thrombi. A pro-coagulant state and an increase of the NET specific marker citrullinated histone H3 (H3Cit) was found in plasma of patients with elevated hsTnT compared to patients with normal levels (p<0.001). Plasma analyses in cancer patients showed even higher H3Cit levels (p<0.001), and an increase in granulocyte colony-stimulating factor, known to prime neutrophils towards NETosis. H3Cit correlated positively with thrombin-antithrombin complex (p=0.004) and soluble P-selectin (p<0.001), further linking NETosis to the pro-thrombotic state.

Conclusions: The high prevalence of known or occult cancer in our study suggests that cancer-associated arterial microthrombosis may be underestimated. By linking the thrombosis to NETs, we suggest markers of NETosis that could aid in revealing cancer in arterial microthrombosis as well as arterial microthrombosis in cancer.
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http://dx.doi.org/10.1016/j.thromres.2016.01.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4769435PMC
March 2016

Clopidogrel Resistance after Minor Ischemic Stroke or Transient Ischemic Attack is Associated with Radiological Cerebral Small-Vessel Disease.

J Stroke Cerebrovasc Dis 2015 Oct 21;24(10):2348-57. Epub 2015 Aug 21.

Division of Internal Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.

Background: The objective of this study was to compare nonresponders (NR) and responders (R) to clopidogrel with respect to presence of microvascular and macrovascular pathology in a cohort of patients with recent minor ischemic stroke (IS) or transient ischemic attack (TIA).

Methods: Seventy-two patients treated with clopidogrel after IS or TIA were evaluated 1 month after onset. Platelet aggregation was measured by multiple electrode aggregometry (Multiplate). Nonresponse was defined according to recent consensus. The degree of cerebral small-vessel disease (cSVD) was evaluated on computed tomography scans of the brain using Fazekas scale for white matter changes. Carotid atherosclerosis was evaluated by ultrasound or computed tomography/magnetic resonance angiography.

Results: Twenty-two percent of patients were NR. Moderate to extensive cSVD was more common for NR than R, 56% versus 25%, odds ratio 3.9 (1.2-12), P = .03. Correspondingly, 39% of patients with cSVD were NR versus 14% of patients with no or mild cSVD. No differences were found between NR and R in prevalence or severity of carotid atherosclerosis. NR had higher platelet aggregation response than R after stimulation with arachidonic acid or thrombin receptor-activating peptide, indicating a general platelet hyperreactivity. In a univariate analysis, hypertension, previous IS, glucose intolerance, pulse pressure above median, and presence of moderate to extensive cSVD were associated with the NR phenotype.

Conclusions: Nonresponsiveness to clopidogrel after minor IS or TIA is associated with radiological cSVD but not with carotid atherosclerosis.

Practice/implications: Measurement of platelet function is warranted in patients with cSVD. Larger studies on alternative or tailored antiplatelet treatment for these patients should be initiated.
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http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2015.06.024DOI Listing
October 2015

Elevated Troponin Levels in Acute Stroke Patients Predict Long-term Mortality.

J Stroke Cerebrovasc Dis 2015 Oct 31;24(10):2390-6. Epub 2015 Jul 31.

Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.

Background: Elevated plasma levels of troponin in acute stroke patients are common and have in several studies been shown to predict in-hospital and short-term mortality. Little is, however, known about the long-term prognosis of these patients. The aim of this study was to determine patient characteristics and 5-year mortality in patients with acute stroke and troponin elevation on admission.

Methods: A retrospective cohort study of all consecutive patients with acute stroke and a plasma troponin I (TnI) analyzed on admission to Danderyd Hospital between January 1, 2005, and January 1, 2006 (n = 247). Patient characteristics were obtained from the Swedish National Stroke Register, Riksstroke, as well as hospital records. Mortality data were obtained from the Swedish Cause of Death Register.

Results: There were 133 patients (54%) with TnI less than .03 μg/L (normal), 74 patients (30%) with TnI .03-.11 μg/L (low elevation), and 40 patients (16%) with TnI greater than .11 μg/L (high elevation). TnI elevations were associated with a higher age, prior ischemic stroke, chronic heart failure, renal insufficiency, stroke severity, and ST segment elevation or depression on admission. The rate of hyperlipidemia decreased with increasing TnI. Adjusted for age and comorbidity, elevated TnI values on admission had a significantly and sustained increased mortality over the 5-year follow-up, with a hazard ratio of 1.90 (95% confidence interval, 1.33-2.70).

Conclusions: Troponin elevation in patients with acute stroke, even when adjusted for several possible confounders, is associated with an almost 2-fold increased risk of 5-year mortality.
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http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2015.06.043DOI Listing
October 2015

International comparisons of acute myocardial infarction.

Lancet 2014 Jul;384(9940):303-4

Danderyd Hospital, Division of Internal Medicine, 182 88 Stockholm, Sweden.

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http://dx.doi.org/10.1016/S0140-6736(14)61234-4DOI Listing
July 2014

Trousseau's Syndrome, a Previously Unrecognized Condition in Acute Ischemic Stroke Associated With Myocardial Injury.

J Investig Med High Impact Case Rep 2014 Apr-Jun;2(2):2324709614539283. Epub 2014 Jun 24.

Karolinska Institutet, Dept of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd Hospital, Stockholm, Sweden.

Trousseau's syndrome is a well-known malignancy associated hypercoagulative state leading to venous or arterial thrombosis. The pathophysiology is however poorly understood, although multiple mechanisms are believed to be involved. We report a case of Trousseau's syndrome resulting in concomitant cerebral and myocardial microthrombosis, presenting with acute ischemic stroke and markedly elevated plasma troponin T levels suggesting myocardial injury. Without any previous medical history, the patient developed multiple cerebral infarctions and died within 11 days of admission. The patient was postmortem diagnosed with an advanced metastatic adenocarcinoma of the prostate with disseminated cerebral, pulmonary, and myocardial microthrombosis. Further analyses revealed, to the best of our knowledge for the first time in stroke patients, circulating microvesicles positive for the epithelial tumor marker CK18 and citrullinated histone H3 in thrombi, markers of the recently described cancer-associated procoagulant DNA-based neutrophil extracellular traps. We also found tissue factor, the main in vivo initiator of coagulation, both in thrombi and in metastases. Troponin elevation in acute ischemic stroke is common and has repeatedly been associated with an increased risk of mortality. The underlying pathophysiology is however not fully clarified, although a number of possible explanations have been proposed. We now suggest that unexplainable high levels of troponin in acute ischemic stroke deserve special attention in terms of possible occult malignancy.
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http://dx.doi.org/10.1177/2324709614539283DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528894PMC
October 2015

Glucose intolerance and insulin resistance as predictors of low platelet response to clopidogrel in patients with minor ischemic stroke or TIA.

Platelets 2014 25;25(2):102-10. Epub 2013 Mar 25.

Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Internal Medicine , Stockholm , Sweden.

The relation between high on-treatment platelet reactivity (HPR), and the level of glucose intolerance and insulin resistance (IR) was studied in clopidogrel-treated patients with minor ischemic stroke or TIA. The cohort consisted of 66 patients, 11 of which had known type 2 diabetes mellitus (DM). Platelet aggregation in whole blood (Multiplate™) and metabolic variables were measured 1 month after acute onset of neurological symptoms. Glucose tolerance was measured by Oral Glucose Tolerance Test (OGTT). IR was estimated by homeostasis model assessment HOMA-IR. Patients were categorized as "responders" (R) or "non-responders" (NR) to clopidogrel according to an established cut-off in platelet aggregation induced by adenosine diphosphate (ADP). In total, 14/66 (21%) patients were NR. Impaired glucose tolerance (IGT), impaired fasting glucose (IFG) or DM was seen in 13/14 NR (93%), while for R this was the case in 25/52 (48%), p = 0.001. The percentage of NR was 33% in patients with DM and 35% in patients with IGT or IFG. In the group with normal glucose tolerance (NGT) the percentage of NR was low, 4% (1/28). Fasting plasma glucose (f-PG) was higher for NR than for R, 6.0 (5.5-6.7) mM vs. 5.3 (5.0-6.0) mM, p = 0.023. Glycated hemoglobin (HbA1c) did not differ between NR and R. NR also had higher arachidonic acid-induced platelet aggregation than R, and a tendency towards higher aggregation induced by thrombin receptor agonist peptide (TRAP), indicating that HPR reflects a global platelet hyper-reactivity. HOMA-IR was calculated for 52 of the patients above without known diabetes, 9 of which were NR (17%). NR were significantly more insulin resistant than R, with median HOMA-IR 4.5 (3.0-7.4) compared to 2.1 (1.5-3.2) for R, p = 0.001. HOMA-IR and fasting plasma insulin were the only metabolic variables with significant relationships to ADP-induced platelet aggregation. The results suggest that HPR develops in the pre-diabetic phase. A metabolic disturbance with glucose intolerance and/or high level of IR was a pre-requisite for HPR in the tested cohort. Conversely, normal glucose tolerance combined with normal or mildly elevated HOMA-IR excluded HPR. NR are likely to constitute a high-risk group among patients with ischemic cerebrovascular disease. Measurement of f-PG or HbA1c is insufficient to identify NR, while OGTT and HOMA-IR are more predictive.
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http://dx.doi.org/10.3109/09537104.2013.777951DOI Listing
October 2014

Gender differences in quality of life after stroke and TIA: a cross-sectional survey of out-patients.

J Clin Nurs 2012 Aug;21(15-16):2386-91

Division of Internal Medicine, Danderyd Hospital, Stockholm, Sweden.

Aims And Objectives: To explore how a stroke or a transient ischemic attack affects quality of life and to identify gender differences.

Background: The negative effect of a stroke on the patients' quality of life has previously been studied, while the effect on patients with transient ischemic attack (TIA) is more unknown, especially in relation to gender. As poor quality of life may have a negative effect on rehabilitation it is important to investigate quality of life in this group.

Design: A descriptive cross-sectional survey.

Methods: All stroke and transient ischemic attack patients appointed to the out-patient stroke clinic between May 2008-August 2009 were asked to complete the Nottingham Health Profile.

Results: Of 1048 patients, 379 (50%) of the stroke patients and 117 (40%) of the patients with transient ischemic attack completed the form within the first months after onset. Female stroke patients were significantly more negatively affected in all domains except the social domain than were male stroke patients. Female transient ischemic attack patients were significantly more negatively affected in all domains than were male transient ischemic attack patients. Male stroke patients had a significantly more negatively affected quality of life than male transient ischemic attack patients in the emotional, energy, social and total domains, while female stroke patients and female transient ischemic attack patients were equally negatively affected.

Conclusions: This study shows that female stroke patients are more negatively affected in their quality of life than male stroke patients and that female transient ischemic attack patients are as affected as female stroke patients. This indicates that female patients with both stroke and TIA need more attention concerning their life situation.

Relevance To Clinical Practice: Increased knowledge about how transient ischemic attack patients are affected, indicate that this group need support postdischarge to the same extension as stroke patients.
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http://dx.doi.org/10.1111/j.1365-2702.2011.04064.xDOI Listing
August 2012

Quality of life in chronic disease: a comparison between patients with heart failure and patients with aphasia after stroke.

J Clin Nurs 2010 Jul;19(13-14):1855-60

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden.

Objectives: This study aimed to describe the impact of heart failure and of stroke with aphasia on quality of life (QoL) and to compare the different domains of QoL in these groups.

Background: The prevalence of chronic conditions has increased during the last decades, and chronic diseases such as stroke and heart failure may have a great impact on QoL.

Design: Comparative study of patients from two randomised controlled studies.

Method: Seventy-nine patients with heart failure and 70 patients with aphasia after stroke were evaluated concerning the severity of their disease and by QoL, as measured with the Nottingham Health Profile, in the acute phase and after six months.

Results: The severity of the disease improved between baseline and six month for both groups. Correlations between New York Heart Association (NYHA) class and all QoL domains were seen in patients with heart failure after six months. The degree of aphasia correlated to mobility, social, emotional and total score after six month. QoL in patients with heart failure was more affected in the domains of sleep and energy in the acute phase and in the energy domain at six months.

Conclusion: Although low energy is more frequent among patients with heart failure, both groups report poor QoL. Improvement in severity of the disease is not necessarily accompanied by improvement in QoL.

Relevance To Clinical Practice: Nottingham Health Profile can easily be used as a screening instrument, aiming to identify patients at risk for adverse effects on QoL. A better understanding of the subjective QoL of patients with chronic disease is fundamental for health care professionals to be able to identify and support vulnerable patients.
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http://dx.doi.org/10.1111/j.1365-2702.2010.03219.xDOI Listing
July 2010

Predictors of life situation among significant others of depressed or aphasic stroke patients.

J Clin Nurs 2008 Jun;17(12):1574-80

Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.

Aim: The aim of this study was to examine predictors of the life situation of the significant other of depressed or aphasic stroke patients.

Background: Depression and aphasia are common consequences of stroke, and both may put pressure on the significant other who have to deal not only with a possible physical handicap but also with communication and/or serious psychiatric difficulties.

Design: Descriptive, cross-sectional study.

Methods: The participants were significant others of 71 depressed and 77 aphasic stroke patients. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorder, and degree of aphasia was diagnosed with the Amsterdam Nijmegen Everyday Language Test. Assessments of the life situation, state of depression and aggression, personality change and need of assistance were made through questionnaires issued to the significant others.

Results: Perceived need of assistance was the only common predictor of life situation of the significant other in both groups (p < 0.001). With respect to the aphasic patients, perceived personality change (p < 0.001) and living with the patient (p = 0.004) were factors that had a negative effect on the life situation of the significant other.

Conclusions: This study highlights that the perception of the patient's need of assistance is an important factor in predicting the life situation among spouses of depressed as well as aphasic stroke patients. A comparison of the two groups to explain the life situation of the significant others revealed greater explanatory power for the aphasic group.

Relevance To Clinical Practice: Assessments of the spouses' perception as well as of the patients' factual situation may identify those significant others at risk. With this new approach, necessary steps may be taken to alleviate pressure on the significant other.
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http://dx.doi.org/10.1111/j.1365-2702.2007.02216.xDOI Listing
June 2008

Clinical and prognostic properties of standardized and functional aphasia assessments.

J Rehabil Med 2007 May;39(5):387-92

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Internal Medicine, Stockholm, Sweden.

Objective: To compare standardized and functional aphasia tests in patients after acute stroke.

Design: Data were collected at baseline and at 6 months in 2 prospective single-centre studies: one observational study (study I, n=119) and one randomized trial of moclobemide vs placebo (study II, n=89).

Subjects: Patients with aphasia after acute stroke.

Methods: Degree of aphasia was examined using the Coefficient (Coeff) in Norsk Grunntest for Afasi (standardized) and the Amsterdam-Nijmegen Everyday Language Test (ANELT) (functional). Statistical comparisons were made using one-way analysis of variance and multivariate regression analyses.

Results: The degree of aphasia measured with Coeff and ANELT correlated closely throughout the study (r2=0.71-0.87, p<0.0001). In study I, 24 patients recovered completely within 6 months. A Coeff >or= 49 and ANELT >or= 3.5 predicted complete recovery equally well. Coeff was sensitive to differentiate between patients with low values on ANELT, whereas ANELT was sensitive to differentiate between patients with high Coeff values.

Conclusion: The 2 tests show a close and consistent correlation over time and are equally sensitive to improvement. They have a similar capacity to predict complete recovery. A standardized test appears to be more suitable for patients with aphasia in the acute stage, while a functional test is more suitable in the subacute/chronic stage.
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http://dx.doi.org/10.2340/16501977-0070DOI Listing
May 2007