Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial. Issue 2 (30th November 2021)

• Record Type: Journal Article
• Authors: Yassi, Nawaf; Zhao, Henry; Churilov, Leonid; Campbell, Bruce C V; Wu, Teddy; Ma, Henry; Cheung, Andrew; Kleinig, Timothy; Brown, Helen; Choi, Philip; Jeng, Jiann-Shing; Ranta, Annemarei; Wang, Hao-Kuang; Cloud, Geoffrey C; Grimley, Rohan; Shah, Darshan; Spratt, Neil; Cho, Der-Yang; Mahawish, Karim; Sanders, Lauren; Worthington, John; Clissold, Ben; Meretoja, Atte; Yogendrakumar, Vignan; Ton, Mai Duy; Dang, Duc Phuc; Phuong, Nguyen Thai My; Nguyen, Huy-Thang; Hsu, Chung Y; Sharma, Gagan; Mitchell, Peter J; Yan, Bernard; Parsons, Mark W; Levi, Christopher; Donnan, Geoffrey A; Davis, Stephen M;
• Is Part Of: Stroke and vascular neurology. Volume 7:Issue 2(2022)
• Page Start: 158
• Page End: 165
• Publication Date: 2021-11-30
• Subjects: stroke -- hemorrhage -- CT; Cerebrovascular disease -- Periodicals; Cardiovascular system -- Diseases -- Periodicals; 616.81005
• DOI: 10.1136/svn-2021-001070
• Languages: English
• ISSNs: 2059-8688

Abstract

Abstract : 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.