RT Journal Article
SR Electronic
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
FD BMJ Publishing Group Ltd
SP 158
OP 165
DO 10.1136/svn-2021-001070
VO 7
IS 2
A1 Yassi, Nawaf
A1 Zhao, Henry
A1 Churilov, Leonid
A1 Campbell, Bruce C V
A1 Wu, Teddy
A1 Ma, Henry
A1 Cheung, Andrew
A1 Kleinig, Timothy
A1 Brown, Helen
A1 Choi, Philip
A1 Jeng, Jiann-Shing
A1 Ranta, Annemarei
A1 Wang, Hao-Kuang
A1 Cloud, Geoffrey C
A1 Grimley, Rohan
A1 Shah, Darshan
A1 Spratt, Neil
A1 Cho, Der-Yang
A1 Mahawish, Karim
A1 Sanders, Lauren
A1 Worthington, John
A1 Clissold, Ben
A1 Meretoja, Atte
A1 Yogendrakumar, Vignan
A1 Ton, Mai Duy
A1 Dang, Duc Phuc
A1 Phuong, Nguyen Thai My
A1 Nguyen, Huy-Thang
A1 Hsu, Chung Y
A1 Sharma, Gagan
A1 Mitchell, Peter J
A1 Yan, Bernard
A1 Parsons, Mark W
A1 Levi, Christopher
A1 Donnan, Geoffrey A
A1 Davis, Stephen M
YR 2022
UL http://svn.bmj.com/content/7/2/158.abstract
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.