{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T22:21:57Z","timestamp":1769120517546,"version":"3.49.0"},"reference-count":30,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2021,11,30]],"date-time":"2021-11-30T00:00:00Z","timestamp":1638230400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Medical Research Future Fund, Australia","award":["APP1152282"],"award-info":[{"award-number":["APP1152282"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Stroke Vasc Neurol"],"accepted":{"date-parts":[[2021,10,12]]},"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:sec>\n                  <jats:title>Rationale<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and design<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Hypothesis<\/jats:title>\n                  <jats:p>In patients with spontaneous ICH, treatment with tranexamic acid within 2\u2009hours of onset will reduce haematoma expansion compared with placebo.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Sample size estimates<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Intervention<\/jats:title>\n                  <jats:p>Participants will receive 1\u2009g intravenous tranexamic acid over 10\u2009min, followed by 1\u2009g intravenous tranexamic acid over 8\u2009hours; or matching placebo.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Primary efficacy measure<\/jats:title>\n                  <jats:p>The primary efficacy measure is the proportion of patients with haematoma growth by 24\u00b16 hours, defined as either \u226533% relative increase or \u22656\u2009mL absolute increase in haematoma volume between baseline and follow-up CT scan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2\u2009hours from onset, based in participating mobile stroke units and emergency departments.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/svn-2021-001070","type":"journal-article","created":{"date-parts":[[2021,11,30]],"date-time":"2021-11-30T12:08:59Z","timestamp":1638274139000},"page":"158-165","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct03385928","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0685-0060","authenticated-orcid":false,"given":"Nawaf","family":"Yassi","sequence":"first","affiliation":[{"name":"Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia"},{"name":"Population Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4320-4287","authenticated-orcid":false,"given":"Henry","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia"},{"name":"Ambulance 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