International journal of stroke : official journal of the International Stroke Society
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Randomized Controlled Trial Multicenter Study
Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design.
Rationale Acute intracerebral hemorrhage inflicts a high-economic and -health burden. Computed tomography angiography spot sign is a predictor of hematoma expansion, is associated with poor clinical outcome and is an important stratifying variable for patients treated with haemostatic therapy. Aims We aim to compare the effect of treatment with tranexamic acid to placebo for the prevention of hemorrhage growth in patients with high-risk acute intracerebral hemorrhage with a positive spot sign. ⋯ The primary outcome measure is the presence of hemorrhage growth defined as an increase in intracerebral hemorrhage volume >33% or >6 ml from baseline to 24 ± 2 h. The secondary outcomes include safety and clinical outcomes. Conclusion The TRAIGE trial evaluates the efficacy of haemostatic therapy with tranexamic acid in the prevention of hemorrhage growth among high-risk patients with acute intracerebral hemorrhage.
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Randomized Controlled Trial Multicenter Study
Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot).
Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. ⋯ Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.
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Randomized Controlled Trial Multicenter Study
ASPREE-NEURO study protocol: A randomized controlled trial to determine the effect of low-dose aspirin on cerebral microbleeds, white matter hyperintensities, cognition, and stroke in the healthy elderly.
Rationale Cerebral microbleeds seen on brain magnetic resonance imaging are markers of small vessel disease, linked to cognitive dysfunction and increased ischemic and hemorrhagic stroke risk. Observational studies suggest that aspirin use may induce cerebral microbleeds, and associated overt intracranial hemorrhage, but this has not been definitively resolved. Aims ASPREE-NEURO will determine the effect of aspirin on cerebral microbleed development over three years in healthy adults aged 70 years and over, participating in the larger 'ASPirin in Reducing Events in the Elderly (ASPREE)' primary prevention study of aspirin. ⋯ Secondary outcomes are the number of new cerebral microbleeds after one year, change in volume of white matter hyperintensity, cognitive function, and stroke. Discussion ASPREE-NEURO will resolve whether aspirin affects the presence and number of cerebral microbleeds, their relationship with cognitive performance, and indicate whether consideration of cerebral microbleeds alters the risk-benefit profile of aspirin in primary prevention for older people. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613001313729.
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Randomized Controlled Trial Multicenter Study
Effects of early blood pressure reduction on cognitive function in patients with acute ischemic stroke.
The effect of early blood pressure reduction on cognitive function in patients with acute ischemic stroke remains unknown. ⋯ These data indicated that early blood pressure reduction with antihypertensive medication in patients with acute ischemic stroke had no effect on cognitive impairment at 3 months.
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Multicenter Study
Should we exclude acute stroke patients with previous intracerebral hemorrhage from receiving intravenous thrombolysis?
Current guidelines have contraindicated history of intracerebral hemorrhage for intravenous recombinant tissue plasminogen activator. ⋯ Previous intracerebral hemorrhage may neither increase the risk of symptomatic hemorrhagic transformation nor alter major clinical outcomes in acute ischemic stroke patients receiving intravenous recombinant tissue plasminogen activator. This study suggests reconsideration of prior history of intracerebral hemorrhage as an exclusion criterion for intravenous recombinant tissue plasminogen activator administration in acute ischemic stroke.