TY - JOUR T1 - Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial JF - Stroke and Vascular Neurology JO - Stroke Vasc Neurol DO - 10.1136/svn-2021-001070 SP - svn-2021-001070 AU - Nawaf Yassi AU - Henry Zhao AU - Leonid Churilov AU - Bruce C V Campbell AU - Teddy Wu AU - Henry Ma AU - Andrew Cheung AU - Timothy Kleinig AU - Helen Brown AU - Philip Choi AU - Jiann-Shing Jeng AU - Annemarei Ranta AU - Hao-Kuang Wang AU - Geoffrey C Cloud AU - Rohan Grimley AU - Darshan Shah AU - Neil Spratt AU - Der-Yang Cho AU - Karim Mahawish AU - Lauren Sanders AU - John Worthington AU - Ben Clissold AU - Atte Meretoja AU - Vignan Yogendrakumar AU - Mai Duy Ton AU - Duc Phuc Dang AU - Nguyen Thai My Phuong AU - Huy-Thang Nguyen AU - Chung Y Hsu AU - Gagan Sharma AU - Peter J Mitchell AU - Bernard Yan AU - Mark W Parsons AU - Christopher Levi AU - Geoffrey A Donnan AU - Stephen M Davis Y1 - 2021/11/30 UR - http://svn.bmj.com/content/early/2021/11/29/svn-2021-001070.abstract N2 - 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.Data are available upon reasonable request. ER -