Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial
- Author(s)
- Yassi, N; Zhao, H; Churilov, L; Campbell, BCV; Wu, T; Ma, H; Cheung, A; Kleinig, T; BROWN, H; Choi, P; Jeng, JS; Ranta, A; Wang, HK; Cloud, GC; Grimley, R; Shah, D; Spratt, N; Cho, DY; Mahawish, K; Sanders, L; Worthington, J; Clissold, B; Meretoja, A; Yogendrakumar, V; Ton, MD; Dang, DP; Phuong, NTM; Nguyen, HT; Hsu, CY; Sharma, G; Mitchell, PJ; Yan, B; Parsons, MW; Levi, C; Donnan, GA; Davis, SM;
- Journal Title
- Stroke and Vascular Neurology
- Publication Type
- epub ahead of print
- 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.
- Keywords
- Ct; hemorrhage; stroke;
- Research Division(s)
- Population Health And Immunity
- PubMed ID
- 34802442
- Publisher's Version
- https://doi.org/10.1136/svn-2021-001070
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2021-12-07 12:04:24
Last Modified: 2021-12-20 01:58:06