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| 1 | Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase Ⅱ randomised placebo-controlled double-blind multicentre trial显示文摘Rationale Haematoma growth is common early after intracerebral haemorrhage(ICH),and is a key determinant of outcome.Tranexamic acid,a widely available antifibrinolytic agent with an excellent safety profile,may reduce haematoma growth.Methods and design Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units(STOP-MSU)is a phase Ⅱ double-blind,randomised,placebo-controlled,multicentre,international investigator-led clinical trial,conducted within the estimand statistical framework.Hypothesis In patients with spontaneous ICH,treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.Sample size estimates A sample size of 180 patients(90 in each arm)would be required to detect an absolute difference in the primary outcome of 20%(placebo 39%vs treatment 19%)under a two-tailed significance level of 0.05.An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.Intervention Participants will receive 1 g intravenous tranexamic acid over 10 min,followed by 1 g intravenous tranexamic acid over 8 hours;or matching placebo.Primary efficacy measure The primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours,defined as either≥33%relative increase or≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan.Discussion We describe the rationale and protocol of STOP-MSU,a phase Ⅱ trial of tranexamic acid in patients with ICH within 2 hours from onset,based in participating mobile stroke units and emergency departments. | Nawaf Yassi Henry Zhao Leonid Churilov Bruce C V Campbell Teddy Wu Henry Ma Andrew Cheung Timothy Kleinig Helen Brown Philip Choi Jiann-Shing Jeng Annemarei Ranta Hao-Kuang Wang Geoffrey C Cloud Rohan Grimley Darshan Shah Neil Spratt Der-Yang Cho Karim Mahawish Lauren Sanders John Worthington Ben Clissold Atte Meretoja Vignan Yogendrakumar Mai Duy Ton Duc Phuc Dang Nguyen Thai My Phuong Huy-Thang Nguyen Chung Y Hsu Gagan Sharma Peter J Mitchell Bernard Yan Mark W Parsons Christopher Levi Geoffrey A Donnan Stephen M Davis | 2022 | Stroke & Vascular Neurology2022，7，2： | 1 |
| 2 | Predicting long-term outcomes in acute intracerebral haemorrhage using delayed prognostication scores显示文摘Objective The concept of the‘self-fulfilling prophecy’is well established in intracerebral haemorrhage(ICH).The ability to improve prognostication and prediction of long-term outcomes during the first days of hospitalisation is important in guiding conversations around goals of care.We previously demonstrated that incorporating delayed imaging into various prognostication scores for ICH improves the predictive accuracy of 90-day mortality.However,delayed prognostication scores have not been used to predict long-term functional outcomes beyond 90 days.Design,setting and participants We analysed data from the ICH Deferoxamine trial to see if delaying the use of prognostication scores to 96 hours after ICH onset will improve performance to predict outcomes at 180 days.276 patients were included.Interventions and measurements We calculated the original ICH score(oICH),modified-ICH score(MICH),max-ICH score and the FUNC score on presentation(baseline),and on day 4(delayed).Outcomes assessed were mortality and poor functional outcome in survivors(defined as modified Rankin Scale of 4-5)at 180 days.We generated receiver operating characteristic curves,and measured the area under the curve values(AUC)for mortality and functional outcome.We compared baseline and delayed AUCs with non-parametric methods.Results At 180 days,21 of 276(7.6%)died.Out of the survivors,54 of 255 had poor functional outcome(21.2%).The oICH,MICH and max-ICH performed significantly better at predicting 180-day mortality when calculated 4 days later compared with their baseline equivalents((0.74 vs 0.83,p=0.005),(0.73 vs 0.80,p=0.036),(0.74 vs 0.83,p=0.008),respectively).The delayed calculation of these scores did not significantly improve our accuracy for predicting poor functional outcomes.Conclusion Delaying the calculation of prognostication scores in acute ICH until day 4 improved prediction of 6-month mortality but not functional outcomes.Trial registration number ClinicalTrials.gov Registry(NCT02175225). | Ronda Lun Vignan Yogendrakumar Tim Ramsay Michel Shamy Robert Fahed Magdy H Selim Dar Dowlatshahi | 2021 | Stroke & Vascular Neurology2021，6，4： | 1 |
| 3 | Identifying sex-specific differences in the carotid revascularisation literature:findings from a scoping review显示文摘Objective No systematic review of the literature has dedicated itself to looking at the management of symptomatic carotid stenosis in female patients.In this scoping review,we aimed to identify all randomised controlled trials(RCTs)that reported sex-specific outcomes for patients who underwent carotid revascularisation,and determine whether sufficient information is reported within these studies to assess short-term and long-term outcomes in female patients.Design,setting and participants We systematically searched Medline,Embase,Pubmed and Cochrane libraries for RCTs published between 1991 and 2020 that included female patients and compared either endarterectomy with stenting,or any revascularisation(endarterectomy or stenting)with medical therapy in patients with symptomatic high-grade(>50%)carotid stenosis.Results From 1537 references examined,27 eligible studies were identified.Sex-specific outcomes were reported in 13 studies.Baseline patient characteristics of enrolled female patients were reported in 2 of those 13 studies.Common outcomes reported included stroke and death,however,there was significant heterogeneity in the reporting of both periprocedural and long-term outcomes.Sex-specific differences relating to the degree of stenosis and time from index event to treatment are largely limited to studies comparing endarterectomy to medical therapy.Adverse events were not reported by sex.Conclusions Only half of the previously published RCTs and systematic reviews report sex-specific outcomes.Detailed analyses on the results of carotid artery intervention for female patients with symptomatic stenosis are limited. | Vignan Yogendrakumar Michel Shamy Brian Dewar Dean A Fergusson Dar Dowlatshahi Candyce Hamel Sophia Gocan Mark Fedyk Jean-Louis Mas Peter Rothwell Virginia Howard Olena Bereznyakova On behalf of the WoW-CAD Investigators | 2021 | Stroke & Vascular Neurology2021，6，3： | 0 |
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