Stroke Unit Care Research Articles

Stroke Care During the COVID-19 Pandemic: Asian Stroke Advisory Panel Consensus Statement

The COVID-19 pandemic has impacted the health system worldwide. Stroke is one of the leading causes of death and disability in the world. Asia has a diverse health system and more than two-thirds of strokes occur in this region. The Asian Stroke Advisory Panel (ASAP) conducted a survey among the member countries to explore the impact of COVID-19 on stroke care. The stroke admission numbers have fallen, as have the number of patients who received thrombolysis and mechanical thrombectomy. The stroke unit and rehabilitation beds have been reallocated for COVID-19 care. ASAP recommends emergency department screening of stroke patients for COVID-19 and protected stroke code to be activated for COVID-19 suspect stroke patients. Noncontrast computed tomography (CT), CT angiography, and CT chest are the imaging modalities of choice. All health care professionals involved in triaging, imaging, and stroke care should wear appropriate personal protective equipment. All eligible stroke patients (COVID suspect/positive/non-COVID) should receive intravenous thrombolysis/mechanical thrombectomy. Mobile stroke units and robots can be used wherever available for evaluation and triaging. All stroke patients should receive standard stroke unit care. Limited rehabilitation should be offered to patients and training of caregivers if needed. Telemedicine/telestroke should be used for rehabilitation and follow-up. The ASAP consensus statement can be adapted to suit local and national health care systems.

Abstract P861: The Perception of Missed Nursing Care in Patients With Acute Stroke

Background: “ Missed nursing care” is a unique type of error known as medical underuse. These errors of omission are related to events, such as patient falls, nosocomial infections, and pressure injuries, associated with increased stroke mortality and morbidity. This study aimed to measure the phenomena of missed care in patients with stroke from the perspective of staff RNs working on a stroke unit and neuro intensive care unit at a Comprehensive Stroke Center. Methods: A Missed Care Survey was developed. Building on the work by Kalisch, the new Missed Care Survey focused entirely on nurse-sensitive measures and related evidence-based bundle steps. Two versions of the 25- question ordinal survey were developed, differing only in how the responses were worded. One asked how often care was missed [never missed (5), rarely missed (4), occasionally missed (3), frequently missed (2), always missed (1)]. and the other how frequently care was completed [always completed (5),usually completed (4), etc.).Descriptive statistics were used to evaluate results. Staff volunteered to take the survey during an annual stroke review class, rating their perception of care over the last 30-days. The IRB determined that the human subject regulation did not apply. Results: Completion rate was 93% (n=140). Differences between the two surveys were minimal with the overall summary score being the same (4.1; range 3.5-4.5). Individual scores ranged from 2.6 to 5. Items most frequently described as never missed included timely administration of pre-operative antibiotics and use of barrier precautions with central venous access device insertion. Care most missed included bathing and peri-care (with/without indwelling catheter), mobility, incentive spirometry, and the prevention of loops in urinary drainage catheter tubing. There were minor changes in rankings between the two survey versions. Conclusions: Scores reflect that known interventions to prevent iatrogenic complications are frequently or occasionally missed (or only usually and occasionally completed). Next steps include validation with real time observations. When missed care is not addressed, it can become routine, known as normalization of deviance, negatively impacting patient outcomes and the quality of care.

Abstract P123: Comparing Process, Performance Measures and Clinical Outcome Between Mobile Stroke Unit and Usual Care in Underserved Areas

Background: The efficacy of mobile stroke units (MSU) in improving acute ischemic stroke (AIS) care in developing countries is unknown. We compared performance measures and treatment outcomes between MSU and usual care. Methods: We enrolled patients >18 years of age with a diagnosis of AIS who presented with onset to door < 4.5 hours and stroke code was alert either at the Siriraj MSU (SiMSU) or at the emergency department (ED). The same AIS treatment guideline for intravenous tPA or endovascular treatment (EVT) were applied in both groups. Demographic data, type(s) of reperfusion therapy (tPA and/ or EVT) were recorded. Stroke onset to door (OD), door to CT (DCT), door to needle (DN), and door to puncture (DP) time were collected. Stroke outcome was measured by the modified Rankin Score (mRS) at 3 months. Results: A total of 519 AIS patients (130 from SiMSU and 389 from ED) were enrolled between June 2018 and December 2019. The mean age ( + SD) was 66 ( + 13.9), 254 (48.9%) were male. AIS key process time measures were significantly shorter in the SiMSU with a mean + SD DCT time of 7 + 4.9 vs 16 + 13.7 minutes (p< 0.01), DN time of 21 + 7 vs 34 + 13.8 minutes (p< 0.01) and DP time of 71 + 20 vs 94 + 44.6 minutes, (p<0.01) in SiMSU and ED respectively. Although EVT rate was similar, intravenous tPA rate was significantly higher in SiMSU 59.2% vs 34.4% (p< 0.01). The mRS of 0-2 at 3 months was significantly higher in SiMSU than the ED (67.5% vs 57.9%, p=0.01). Conclusions: The SiMSU significantly shortened door to reperfusion treatment, increased access to IV t-PA and improved stroke outcomes by reducing disability at 3 months when compare to standard of care (i.e. ED arrival). This working paradigm could be implemented in other similar healthcare settings to improved AIS care.

Abstract P120: The Covid Effect on Stroke Response

Background & Significance: The Covid-19 pandemic has created a host of challenges for healthcare systems and hospital teams that have put unprecedented stress on staff and leaders to re-design care and management of not only the Covid positive patient but also the hospitalized non-Covid patient. As this large healthcare system began to prepare for a Covid surge of patients, stroke program leaders recognized the need for alternative placement and management plans. With the re-designation of units and beds and deployment of staff into non-primary units, program leaders were concerned with not only placement of stroke patients outside of regular stroke and Neurocritical Care Units but also with non-trained stroke nursing staff caring for the patient. In response, this stroke program convened a working group to create alternative guidelines for care of the stroke patient during Covid surge and critical bed shortages. Design & Methods: The need for established criteria to guide all sites in the care of patients post IV thrombolytic or mechanical thrombectomy was the key objective. The alternative guideline was drafted and submitted to the system Covid clinical command center for emergent approval. Once approval given, education was provided to all stroke coordinators and key leaders at each site. To provide full access, guidelines were posted and available on the system SharePoint site for access to all team members. Results: The drafting of alternative stroke guidelines allowed for improved patient safety during our 27-hospital healthcare systems Covid surge. Care of multiple patients occurred outside normal critical care and stroke units with a decreased number of assessments for patients from the standard, pre-Covid and without increase safety events or adverse outcomes. The success of the alternative guidelines and this Covid effect on stroke care management not only helped our staff and patients during a time of need in safe care but also provided a new model of care for our stroke program leaders to consider and implement across our organizations.

Abstract 29: Urban versus Non-Urban Hospital Location Impacts on Stroke Outcomes

Introduction: Stroke care provision differs between urban and provincial hospitals predominantly due to economy of scale, which is correlated with resources available and degree of specialisation. We assessed the impact of urban versus non-urban hospital location on stroke outcomes. Methods: REGIONS Care is a New Zealand (NZ) nationwide prospective observational study that included consecutively admitted stroke patients involving all NZ stroke hospitals between 1 May and 31 October 2018. Patients were followed-up at 3, 6, and 12 months. The primary outcome was favourable modified Rankin Score of 0-2. Results were adjusted for age, stroke severity, pre-morbid level of independence and other potential confounders using multivariate logistic regression. Results: Of the 2,379 patients (mean age (SD), 75 (13.7)), 1,963 (82.6%) had ischaemic strokes and 291 (12.3%) haemorrhagic strokes. The odds of achieving a favourable outcome at 3 and 6 months was significantly lower for patients treated in non-urban compared to urban hospitals: aOR 0.72 (95%CI:0.56-0.93; p=0.012) and aOR 0.71 (95%CI:0.52-0.96; p=0.028), respectively. At 12-months this difference was less pronounced (aOR 0.77, 95%CI:0.57-1.04; p=0.089). Similarly, death was significantly more likely at 3 and 6 months, and borderline statistically significant at 12 months: aOR 1.64, 95%CI:1.30-2.29, p=0.001; 1.54, 95%CI:1.12-2.11, p=0.008; and 1.36, 95%CI:0.99-1.87, p=0.06, respectively. Stroke recurrence was similar between urban and non-urban settings at 3 and 6 months, but more likely in the non-urban setting at 12 months (aOR 1.94, 95%CI:1.14-3.29, p=0.014. In the non-urban setting, eligible patients were less likely to receive reperfusion therapy (aOR 0.5, 95%CI:0.28-0.91, p=0.023); acute stroke unit care was less consistently accessed (aOR 0.58, 95%CI:0.48-0.70, p<0.001); and appropriate secondary preventive therapy was less frequently prescribed (aOR 0.50, 95%CI:0.28-0.91, p=0.023). Conclusion: This first comprehensive prospective NZ nationwide stroke study showed significant differences in stroke outcomes and access to key acute stroke interventions between urban and non-urban hospitals. This inequity requires urgent intervention from health system funders and providers.

The use of hypnotherapy as treatment for functional stroke: A case series from a single center in the UK.

BackgroundFunctional neurological disorder is defined by symptoms not explained by the current model of disease and its pathophysiology. It is found in 8.4% of patients presenting as acute stroke. Treatment is difficult and recurrence rates are high. We introduced hypnotherapy as a therapeutic option in addition to standard stroke unit care.MethodsThis is an observational study of successive patients with functional neurological disorder presenting as acute stroke treated with hypnotherapy between 1 April 2014 and 1 February 2018. The diagnosis of functional neurological disorder was confirmed by clinical examination and computed tomography/magnetic resonance imaging. Hypnosis was delivered by a hypnotherapy trained stroke physician using imagery for induction. A positive response was defined as a National Institutes of Health Stroke score reduction to 0 or by ≥4 points posthypnotherapy. Costs were calculated as therapist time and benefits as reduction in disability/bed days.ResultsSixty-eight patients (mean age 36.4 years, 52 (76%) females, mean baseline National Institutes of Health Stroke 5.0 (range 1–9)) were included. Two patients (3%) could not be hypnotized. Fifty-eight 58 (85%) responded, 47 (81%) required one treatment session, while 19% needed up to three sessions for symptomatic improvement. No adverse events were observed. Disability (modified Rankin Scale) reduced from a mean of 2.3 to 0.5 resulting in an average cost saving of £1,658 per patient. Most (n = 50, 86%) remained well without recurrence at six-month follow-up.ConclusionsIn this case series, hypnotherapy was associated with rapid and sustained recovery of symptoms. A prospective randomized controlled study is required to confirm the findings and establish generalizability of the results.

Implementation of a Physician-Based Stroke Unit in a Remote Hospital of North-East India-Tezpur Model.

Objective The study aims to determine the effects of implementing stroke unit (SU) care in a remote hospital in North-East India. Materials and Methods This before-and-after implementation study was performed at the Baptist Christian Mission Hospital, Tezpur, Assam between January 2015 and December 2017. Before the implementation of stroke unit care (pre-SU), we collected information on usual stroke care and 1-month outcome of 125 consecutive stroke admissions. Staff was then trained in the delivery of SU care for 1 month, and the same information was collected in a second (post-SU) cohort of 125 patients. Statistical Analysis Chi-square and Mann–Whitney U test were used to compare group differences. The loss to follow-up was imputed by using multiple imputations using the Markov Chain Monto Carlo method. The sensitivity analysis was also performed by using propensity score matching of the groups for baseline stroke severity (National Institute of Health Stroke Scale) using the nearest neighbor approach to control for confounding, and missing values were imputed by using multiple imputations. The adjusted odds ratio was calculated in univariate and multivariate regression analysis after adjusting for baseline variables. All the analysis was done by using SPSS, version 21.0., IBM Corp and R version 4.0.0., Armonk, New York, United States. Results The pre-SU and post-SU groups were age and gender matched. The post-SU group showed higher rates of swallow assessment (36.8 vs. 0%, p < 0.001), mobility assessment, and re-education (100 vs. 91.5%, p = 0.037). The post-SU group also showed reduced complications (28 vs. 45%, p = 0.006) and a shorter length of hospital stay (4 ± 2.16 vs. 5 ± 2.68 days, p = 0.026). The functional outcome (modified ranking scale) at 1-month showed no difference between the groups, good outcome in post-SU (39.6%) versus pre-SU (35.7%), p = 0.552. Conclusion The implementation of this physician-based SU care model in a remote hospital in India shows improvements in quality measures, complications, and possibly patient outcomes.

Early Mobilization After Stroke: Do Clinical Practice Guidelines Support Clinicians' Decision-Making?

Importance: Early mobilization, out-of-bed activity, is a component of acute stroke unit care; however, stroke patient heterogeneity requires complex decision-making. Clinically credible and applicable CPGs are needed to support and optimize the delivery of care. In this study, we are specifically exploring the role of clinical practice guidelines to support individual patient-level decision-making by stroke clinicians about early mobilization post-stroke.Methods: Our study uses a novel, two-pronged approach. (1) A review of CPGs containing recommendations for early mobilization practices published after 2015 was appraised using purposely selected items from the Appraisal of Guidelines Research and Evaluation–Recommendations Excellence (AGREE-REX) tool relevant to decision-making for clinicians. (2) A cross-sectional study involving semi-structured interviews with Australian expert stroke clinicians representing content experts and CPG target users. Every CPG was independently assessed against the AGREE-REX standard by two reviewers. Expert stroke clinicians, invited via email, were recruited between June 2019 to March 2020.The main outcomes from the review was the proportion of criteria addressed for each AGREE-REX item by individual and all CPG(s). The main cross-sectional outcomes were the distributions of stroke clinicians' responses about the utility of CPGs, specific areas of uncertainty in early mobilization decision-making, and suggested parameters for inclusion in future early mobilization CPGs.Results: In 18 identified CPGs, many did not adequately address the “Evidence” and “Applicability to Patients” AGREE-REX items. Out of 30 expert stroke clinicians (11 physicians [37%], 11 physiotherapists [37%], 8 nurses [26%]; median [IQR] years of experience, 14 [10–25]), 47% found current CPGs “too broad or vague,” while 40% rely on individual clinical judgement and interpretation of the evidence to select an evidence-based choice of action. The areas of uncertainty in decision-making revealed four key suggestions: (1) more granular descriptions of patient and stroke characteristics for appropriate tailoring of decisions, (2) clear statements about when clinical flexibility is appropriate, (3) detailed description of the intervention dose, and (4) physical assessment criteria including safety parameters.Conclusions: The lack of specificity, clinical applicability, and adaptability of current CPGs to effectively respond to the heterogeneous clinical stroke context has provided a clear direction for improvement.

Patterns of Admission and Outcomes for Patients with Intracranial Hemorrhage in Catalonia, Spain

Limited information is available about the hospital types to which patients with intracerebral hemorrhage (ICH) are admitted and treated. This could be important because some effective therapeutic measures can only be administered at comprehensive stroke centers (CSCs). Using the Acute Hospitals Discharge database, which provides population-based information, we identified ICH patients admitted to 7 CSCs and 53 non-CSCs (from January 2015 to December 2016) in Catalonia. CSCs were defined as centers with an emergency department ready to assess and treat code stroke patients around the clock, 24-hour availability of neurology, neurosurgery, and neuroradiology services, and admission to the stroke unit and/or intensive care unit. The database provided the demographics, admitting hospital, and interhospital transfers. Vital status was retrieved from the Central Registry of the Catalan Public Health Insurance. A total of 3339 ICH patients were identified (mean age, 72.2 ± 14.6 years; 56.8% men). Of the 3339 patients, 45.7% were admitted to a CSC and 54.3% to a non-CSC. Transfer from a non-CSC to a CSC occurred for 1.97% of the patients. In-hospital mortality was similar between the CSCs and non-CSCs (30.2% vs. 27.5%; P= 0.09). The long-term mortality was also comparable between the CSC and non-CSC groups (45.4% vs. 47%; P= 0.34). Despite a considerable proportion of ICH patients remaining at a non-CSC for their entire hospitalization, the short- and long-term mortality were comparable between the 2 hospital types. More studies are required to determine whether outcomes other than mortality might be related to the admitting hospital type and whether the routing protocols for ICH patients should be modified.

Factors affecting complications and mortality of stroke patients in Stroke Care Unit

Factors affecting complications and mortality of stroke patients in Stroke Care Unit

Does the physical environment matter? - A qualitative study of healthcare professionals’ experiences of newly built stroke units

ABSTRACT Purpose: Organized care in specialist stroke units is fundamental for achieving better outcomes for persons with stroke. Although the importance of the physical environment for health and well-being is well recognized, research regarding how environmental features can influence stroke care is limited. The aim was to elucidate healthcare professionals’ experiences of the physical environment in newly built stroke units with respect to stroke care.Methods: Healthcare professionals (n = 42) representing eight professions participated in semi-structured, face-to-face interviews. Qualitative content analysis was used.Results: The physical environment both facilitated and restricted the professionals’ ability to provide stroke care. Five categories were identified: “Working towards patient engagement in single rooms”, “Hampered rehabilitation in an environment not always adapted to patients’ difficulties”, “Addressing patients’ psychosocial needs in the environment”, “Ensuring patient safety by using the environment in accordance with individual needs”, and “Collaboration and task fulfilment—a challenge due to care unit design”.Conclusions: The healthcare professionals viewed the physical environment mainly in relation to stroke patients’ specific needs, and several environmental features were considered poorly adapted to meet these needs. The physical environment is essential to high-quality care; thus, the process of planning and designing stroke units should be based on existing evidence.

Elevated Urinary Titin and its Associated Clinical Outcomes after Acute Stroke

IntroductionUrinary titin is a biomarker of muscle atrophy, which is a serious complication after stroke. However, there are currently no clinical data regarding urinary titin in stroke patients. MethodsConsecutive stroke patients admitted to the stroke care unit were included. Spot urine samples were collected immediately after admission, and on days 3, 5, and 7. The primary outcome was the trend of urinary titin in patients after acute stroke. The secondary outcomes included the association between the peak urinary titin level and the modified Rankin Scale (mRS) score, the National Institutes of Health Stroke Scale (NIHSS) score, and the Barthel index (BI) upon hospital discharge. Multivariate analysis was adjusted for age, sex, NIHSS at admission, and the peak urinary titin to predict poor outcome (mRS 3–6). ResultsForty-one patients were included (29 male; age, 68 ± 15 years), 29 had ischemic stroke, 8 had intracerebral hemorrhage, and 4 had subarachnoid hemorrhage. The levels of urinary titin on days 1, 3, 5, and 7 were 9.9 (4.7–21.1), 16.2 (8.6–22.0), 8.9 (4.8–15.2), and 8.7 (3.6–16.2) pmol/mg Cr, respectively. The peak urinary titin level was associated with the mRS score (r = 0.55, p < 0.01), the NIHSS score (r = 0.72, p < 0.01), and the BI (r = −0.59, p < 0.01) upon hospital discharge. In multivariate analysis, the peak urinary titin was associated with poor outcome (p = 0.03). ConclusionsUrinary titin rapidly increased after stroke and was associated with impaired functional outcomes at hospital discharge.

Implementation of the Stroke Action Plan for Europe 2018--2030 during coronavirus disease-2019.

To describe the background, principles and implementation of the Stroke Action Plan for Europe 2018--2030 (SAP-E) in the perspective of the current COVID-19 pandemic. SAP-E sets targets for the implementation of evidence-based preventive actions and stroke services to 2030. A recent mapping of stroke care in Europe has documented massive inequalities and even in high-income European countries access to reperfusion therapy and mortality after ischaemic stroke varies significantly. Organized stroke care providing stroke unit care and access to reperfusion therapies reduces mortality and long-term disability. Stroke prevention and care are highly cost-effective. The COVID-19 pandemic has challenged organized care, diverged attention from stroke and necessitated a novel approach to the implementation program because of the continued need for social distancing and reduced travelling. Consequently, meetings, training and engagement will be handled by online resources. Stroke can be prevented and treated but there remain massive inequalities in Europe. SAP-E has set targets for development of stroke care. COVID-19 pandemic has led to further challenges for stroke care and implementation of the Action Plan will rely on online meetings and resources as it is yet unforeseeable when things will return to normal. http://links.lww.com/CONR/A53.

Качество жизни пациентов в резидуальном периоде ишемического инсульта и определяющие его факторы

Stroke remains one of the leading causes of disability; therefore, it is important to investigate factors that might affect the quality of life of stroke patients and refine rehabilitation technologies for better functional gains. The aim of this paper was to study possible factors that determine the quality of life in the residual ischemic stroke period. The MOS SF-36 health survey was completed by 210 patients undergoing early rehabilitation at a stroke care unit. The study revealed a significant decline in some quality of life indicators correlated with advancing age and severity of the condition (correlation coefficient –0.5; p &lt; 0.01). Both physical and mental component summary scores were lower in women than in men (p &lt; 0.01 and p &lt; 0.001, respectively). High scores on the majority of the applied subscales were observed in the patients with a vertebrobasilar stroke, as compared with those who had suffered a carotid stroke (p &lt; 0.05). The early rehabilitation regimen complemented with acupuncture in the acute stroke period and the subsequent rehabilitation program at the Rehabilitation Hospital significantly contributed (р &lt; 0.05) to improving the quality of life of stroke patients in the residual stroke period.

Organized Inpatient (Stroke Unit) Care for Stroke: Network Meta-Analysis.

Organized Inpatient (Stroke Unit) Care for Stroke: Network Meta-Analysis.

Mobile Stroke Unit versus Standard Medical Care in the Management of patients with Acute Stroke

Online date: November 16, 2020 This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Effects of uncomfortable care and histamine H2-antagonists on delirium in acute stroke: A propensity score analysis

Background and purposeUncomfortable care and histamine H2 antagonist (H2A) are implicated in precipitating delirium. In acute stroke, however, the need for them depends on stroke severity, an established risk factor for delirium. So, it is unclear whether care or H2A itself is responsible for delirium. We aimed to evaluate their causal effects on delirium in acute stroke patients. MethodsThis is a prospective cohort study on acute stroke patients admitted to a stroke care unit. Patients without stupor, coma, sedation, or delirium upon admission were enrolled. The treatment was H2A and five care modalities given during the first 24 h: restraint use, prohibited self-transfer, no oral feeding, indwelling catheters, and frequent nighttime care. The outcome was delirium within 5 days defined as Intensive Care Delirium Screening Checklist ≥4 points. We estimated the relative risk (RR) for delirium with regression models weighted by overlap weights using propensity scores estimated through logistic models incorporating known and potential confounders, including stroke severity. ResultsOf the 387 participants, 188 were given at least one care modality and 130 were given H2A. A total of 42 developed delirium. Delirium was significantly associated with prohibited self-transfer (RR 1.7, 95% CI 1.0–3.0), frequent nighttime care (RR 2.1, 95% CI 1.2–3.7), and multiple care modalities (RR 2.4, 95% CI 1.3–4.4), while other care modalities and H2A were not. ConclusionsThis study showed possible causal effects of uncomfortable care on delirium and suggests that minimizing it could prevent delirium in acute stroke.

Clinical and radiological characteristics and outcome of wake-up intracerebral hemorrhage

There is little information on the characteristics of patients with wake-up intracerebral hemorrhage (WU-ICH). We aimed to evaluate frequency and relevant differences between WU-ICH and while-awake (WA) ICH patients. This is a retrospective study of a prospective database of consecutive patients with spontaneous ICH, who were classified as WU-ICH, WA-ICH or UO-ICH (unclear onset). We collected demographic, clinical and radiological data, prognostic and therapeutic variables, and outcome [(neurological deterioration, mortality, functional outcome (favorable when modified Rankin scale score 0–2)]. From a total of 466 patients, 98 (25.8%) were classified as UO-ICH according to the type of onset and therefore excluded. We studied 368 patients (mean age 73.9 ± 13.8, 51.4% men), and compared 95 (25.8%) WU-ICH with 273 (74.2%) WA-ICH. Patients from the WU-ICH group were significantly older than WA-ICH (76.9 ± 14.3 vs 72.8 ± 13.6, p = 0.01) but the vascular risk factors were similar. Compared to the WA-ICH group, patients from the WU-ICH group had a lower GCS score or a higher NIHSS score and a higher ICH score, and were less often admitted to a stroke unit or intensive care unit. There were no differences between groups in location, volume, rate of hematoma growth, frequency of intraventricular hemorrhage and outcome. One in five patients with spontaneous ICH are WU-ICH patients. Other than age, there are no relevant differences between WU and WA groups. Although WU-ICH is associated with worse prognostic markers vital and functional outcome is similar to WA-ICH patients.

Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial

Despite intracerebral haemorrhage causing 5% of deaths worldwide, few evidence-based therapeutic strategies other than stroke unit care exist. Tranexamic acid decreases haemorrhage in conditions such as acute trauma and menorrhoea. We aimed to assess whether tranexamic acid reduces intracerebral haemorrhage growth in patients with acute intracerebral haemorrhage. We did a prospective, double-blind, randomised, placebo-controlled, investigator-led, phase 2 trial at 13 stroke centres in Australia, Finland, and Taiwan. Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography. Patients were randomly assigned (1:1) to receive either 1 g of intravenous tranexamic acid over 10 min followed by 1 g over 8 h or matching placebo, started within 4·5 h of symptom onset. Randomisation was done using a centralised web-based procedure with randomly permuted blocks of varying size. All patients, investigators, and staff involved in patient management were masked to treatment. The primary outcome was intracerebral haemorrhage growth (>33% relative or >6 mL absolute) at 24 h. The primary and safety analyses were done in the intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT01702636). Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the tranexamic acid group (n=50) or the placebo group (n=50). Median age was 71 years (IQR 57-79) and median intracerebral haemorrhage volume was 14·6 mL (7·9-32·7) at baseline. The primary outcome was not different between the two groups: 26 (52%) patients in the placebo group and 22 (44%) in the tranexamic acid group had intracerebral haemorrhage growth (odds ratio [OR] 0·72 [95% CI 0·32-1·59], p=0·41). There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications. None of the deaths was considered related to study medication. Our study does not provide evidence that tranexamic acid prevents intracerebral haemorrhage growth, although the treatment was safe with no increase in thromboembolic complications. Larger trials of tranexamic acid, with simpler recruitment methods and an earlier treatment window, are justified. National Health and Medical Research Council, Royal Melbourne Hospital Foundation.

Sex differences in quality of life after stroke were explained by patient factors, not clinical care: evidence from the Australian Stroke Clinical Registry.

Women may receive stroke care less often than men. We examined the contribution of clinical care on sex differences and health-related quality of life (HRQoL) after stroke. We included first-ever strokes registered in the Australian Stroke Clinical Registry (2010-2014) with HRQoL assessed between 90 and 180days after onset (EQ-5D-3L instrument) that were linked to hospital administrative data (up to 2013). Study factors included sociodemographics, comorbidities, walking ability on admission (stroke severity proxy) and clinical care (e.g. stroke unit care). Responses to the EQ-5D-3L were transformed into a total utility value (-0.516 'worse than death' to 1 'best' health). Quantile regression models, adjusted for confounding factors, were used to determine median differences (MD) in utility scores by sex. Approximately 60% (6852/11418) of stroke survivors had an EQ-5D-3L assessment (median 139days; 44% female). Compared with men, women were older (median age 77.1 years vs. men 71.2 years) and fewer could walk on admission (37.9% vs. men 46.1%, P<0.001). Women had lower utility values than men, and the difference was explained by age and stroke severity, but not clinical care [MDadjusted = -0.039, 95% confidence interval: -0.056, -0.021]. Poorer HRQoL was observed in younger men (aged<65years), particularly those with more comorbidities, and in older women (aged≥75years). Stroke severity and comorbidities contribute to the poorer HRQoL in young men and older women. Further studies are needed to understand age-sex interaction to better inform treatments for different subgroups and ensure evidence-based treatments to reduce the severity of stroke are prioritized.