Tranexamic acid for hyperacute primary intracerebral haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial

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dc.contributor.authorSprigg, Nikola
dc.contributor.authorFlaherty, Katie
dc.contributor.authorAppleton, Jason P.
dc.contributor.authorSalman, Rustam Al-Shahi
dc.contributor.authorBereczki, Daniel
dc.contributor.authorBeridze, Maia
dc.contributor.authorChristensen, Hanne
dc.date.accessioned2020-03-26T20:11:37Z
dc.date.available2020-03-26T20:11:37Z
dc.date.issued2018
dc.departmentSelçuk Üniversitesien_US
dc.description.abstractBackground Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. Methods We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1: 1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset. Randomisation was done centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214. Findings We recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0.88, 95% CI 0.76-1.03, p= 0.11). Although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0.73, 0.53-0.99, p= 0.0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0.92, 95% CI 0.77-1.10, p= 0.37). Fewer patients had serious adverse events after tranexamic acid than after placebo by days 2 (379 [33%] patients vs 417 [36%] patients), 7 (456 [39%] vs 497 [43%]), and 90 (521 [45%] vs 556 [48%]). Interpretation Functional status 90 days after intracerebral haemorrhage did not differ significantly between patients who received tranexamic acid and those who received placebo, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect. Funding National Institute of Health Research Health Technology Assessment Programme and Swiss Heart Foundation. Copyright (C) 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.en_US
dc.description.sponsorshipNational Institute of Health Research Health Technology Assessment ProgrammeNational Institute for Health Research (NIHR); Swiss Heart Foundationen_US
dc.description.sponsorshipFunding National Institute of Health Research Health Technology Assessment Programme and Swiss Heart Foundation.en_US
dc.identifier.doi10.1016/S0140-6736(18)31033-Xen_US
dc.identifier.endpage2115en_US
dc.identifier.issn0140-6736en_US
dc.identifier.issn1474-547Xen_US
dc.identifier.issue10135en_US
dc.identifier.pmid29778325en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage2107en_US
dc.identifier.urihttps://dx.doi.org/10.1016/S0140-6736(18)31033-X
dc.identifier.urihttps://hdl.handle.net/20.500.12395/37093
dc.identifier.volume391en_US
dc.identifier.wosWOS:000433257200026en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherELSEVIER SCIENCE INCen_US
dc.relation.ispartofLANCETen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.selcuk20240510_oaigen_US
dc.titleTranexamic acid for hyperacute primary intracerebral haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trialen_US
dc.typeArticleen_US

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