• Int J Stroke · Aug 2016

    Randomized Controlled Trial

    Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: Protocol for a randomized, placebo-controlled trial.

    • Nikola Sprigg, Katie Robson, Philip Bath, Robert Dineen, Ian Roberts, Tom Robinson, Christine Roffe, David Werring, Rustam Al-Shahi Salman, Stuart Pocock, Lelia Duley, Tim England, David Whynes, Alfonso Ciccone, Ann Charlotte Laska, Hanne Christensen, Serefnur Ozturk, Ronan Collins, Daniel Bereczki, Juan Jose Egea-Guerrero, Zhe Kang Law, Anna Czlonkowska, David Seiffge, Maia Beredzie, and TICH-2 Investigators.
    • Stroke, Division of Clinical Neuroscience, Nottingham, UK Nikola.sprigg@nottingham.ac.uk.
    • Int J Stroke. 2016 Aug 1; 11 (6): 683-94.

    RationaleOutcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions.AimThis randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontaneous intracerebral hemorrhage reduces death or dependency.DesignPhase III prospective double-blind randomized placebo-controlled trial. Participants within 8 h of spontaneous intracerebral hemorrhage are randomized to receive either intravenous tranexamic acid 1 g 10 min bolus followed by 1 g 8 h infusion, or placebo.Sample Size EstimatesA trial of 2000 participants (300 from start-up phase and 1700 from main phase) will have 90% power to detect an ordinal shift of the modified Rankin Scale with odds ratio 0.79.Study OutcomesThe primary outcome is death or dependency measured by ordinal shift analysis of the 7 level mRS at day 90. Secondary outcomes are neurological impairment at day 7 and disability, quality of life, cognition, and mood at day 90. Safety outcomes are death, serious adverse events, thromboembolic events, and seizures. Cost outcomes are length of stay in hospital, readmission, and institutionalization.DiscussionThis pragmatic trial is assessing efficacy of tranexamic acid after spontaneous intracerebral hemorrhage. Recruitment started in 2013; as of 15th January 2016 1355 participants have been enrolled, from 95 centers in seven countries. Recruitment is due to end in 2017. TICH-2 Trial is registered as ISRCTN93732214.© 2016 World Stroke Organization.

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