Tranexamic acid for spontaneous intracerebral hemorrhage:
a randomized controlled pilot trial (ISRCTN50867461)

Sprigg, Nikola; Renton, Cheryl J.; Dineen, Robert A.; Kwong, Yune; Bath, Philip M.W.

Abstract

Background: Spontaneous intracerebral hemorrhage (ICH) can be devastating, particularly if hematoma expansion (HE) occurs. Tranexamic acid (TA), an antifibrinolytic drug, significantly reduced mortality in bleeding patients after trauma in the large CRASH-2 trial. The CRASH-2 ICH substudy found that TA nonsignificantly reduced mortality and dependency in traumatic ICH. The aim of this study was to assess the feasibility of performing a randomized controlled trial of tranexamic acid in spontaneous ICH, ahead of a definitive study.
Methods: We performed a single-center, prospective, randomized (2:1), double-blind, placebo-controlled blinded endpoint trial of TA (intravenous 1 g bolus, 1 g infusion/8 h) in acute (<24 hours) spontaneous ICH. The primary objective was to test the feasibility of recruiting to the trial. Other objectives included tolerability (adverse events) and the effect of TA on HE and death and dependency.
Results: The trial was feasible, with 24 patients enrolled (TA, n 5 16; placebo, n 5 8) between March 2011 and March 2012, and acceptable—only 3 patients declined to participate. All patients received the correct randomized treatment; 1 patient in the TA group did not complete the infusion because of neurologic deterioration. There were no significant differences in secondary outcomes including adverse events, HE, death, and dependency. One patient in the TA group had a deep vein thrombosis.
Conclusions: This, the first randomized controlled trial of TAin ICH, found that the protocol could be delivered on schedule (2 patients/mo) and was feasible. Larger studies are needed to assess safety and efficacy of TA in ICH.

Citation

a randomized controlled pilot trial (ISRCTN50867461). Journal of Stroke and Cerebrovascular Diseases, 23(6), 1312-1318. https://doi.org/10.1016/j.jstrokecerebrovasdis.2013.11.007

• Journal Article Type: Article
• Acceptance Date: Nov 15, 2013
• Online Publication Date: Mar 31, 2014
• Publication Date: 2014-07
• Deposit Date: Oct 19, 2016
• Publicly Available Date: Oct 19, 2016
• Journal: Journal of Stroke and Cerebrovascular Diseases
• Print ISSN: 1052-3057
• Electronic ISSN: 1532-8511
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 23
• Issue: 6
• Pages: 1312-1318
• DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2013.11.007
• Keywords: acute stroke, intracerebral hemorrhage, tranexamic acid, randomized controlled trials
• Public URL: https://nottingham-repository.worktribe.com/output/724087
• Publisher URL: http://www.sciencedirect.com/science/article/pii/S1052305713004734
• Contract Date: Oct 19, 2016