PT  - JOURNAL ARTICLE
AU  - Yassi, Nawaf
AU  - Zhao, Henry
AU  - Churilov, Leonid
AU  - Campbell, Bruce C V
AU  - Wu, Teddy
AU  - Ma, Henry
AU  - Cheung, Andrew
AU  - Kleinig, Timothy
AU  - Brown, Helen
AU  - Choi, Philip
AU  - Jeng, Jiann-Shing
AU  - Ranta, Annemarei
AU  - Wang, Hao-Kuang
AU  - Cloud, Geoffrey C
AU  - Grimley, Rohan
AU  - Shah, Darshan
AU  - Spratt, Neil
AU  - Cho, Der-Yang
AU  - Mahawish, Karim
AU  - Sanders, Lauren
AU  - Worthington, John
AU  - Clissold, Ben
AU  - Meretoja, Atte
AU  - Yogendrakumar, Vignan
AU  - Ton, Mai Duy
AU  - Dang, Duc Phuc
AU  - Phuong, Nguyen Thai My
AU  - Nguyen, Huy-Thang
AU  - Hsu, Chung Y
AU  - Sharma, Gagan
AU  - Mitchell, Peter J
AU  - Yan, Bernard
AU  - Parsons, Mark W
AU  - Levi, Christopher
AU  - Donnan, Geoffrey A
AU  - Davis, Stephen M
TI  - Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial
AID  - 10.1136/svn-2021-001070
DP  - 2022 Apr 01
TA  - Stroke and Vascular Neurology
PG  - 158--165
VI  - 7
IP  - 2
4099  - http://svn.bmj.com/content/7/2/158.short
4100  - http://svn.bmj.com/content/7/2/158.full
SO  - Stroke Vasc Neurol2022 Apr 01; 7
AB  - 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.