Journal
BMJ OPEN
Volume 8, Issue 2, Pages -Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2017-019930
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Funding
- British Heart Foundation [PG/14/96/31262]
- Health Technology Assessment Programme [11_129_109]
- British Heart Foundation [SP/12/2/29422, PG/14/96/31262, PG/14/50/30891] Funding Source: researchfish
- Chest Heart and Stroke Scotland [Res10/A127] Funding Source: researchfish
- Medical Research Council [MR/M009211/1, G1002605] Funding Source: researchfish
- National Institute for Health Research [NF-SI-0515-10044, NF-SI-0611-10057, 14/190/01, 11/129/109, 06/303/20] Funding Source: researchfish
- MRC [MR/M009211/1, G1002605] Funding Source: UKRI
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Objectives To test whether administration of the antifibrinolytic drug tranexamic acid (TXA) in patients with spontaneous intracerebral haemorrhage (SICH) leads to increased prevalence of diffusion-weighted MRI-defined hyperintense ischaemic lesions (primary hypothesis) or reduced perihaematomal oedema volume, perihaematomal diffusion restriction and residual MRI-defined SICH-related tissue damage (secondary hypotheses). Design MRI substudy nested within the double-blind randomised controlled Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 trial (ISRCTN93732214). Setting International multicentre hospital-based study. Participants Eligible adults consented and randomised in the TICH-2 trial who were also able to undergo MRI scanning. To address the primary hypothesis, a sample size of n=280 will allow detection of a 10% relative increase in prevalence of diffusion-weighted imaging (DWI) hyperintense lesions in the TXA group with 5% significance, 80% power and 5% imaging data rejection. Interventions TICH-2 MRI substudy participants will undergo MRI scanning using a standardised protocol at day similar to 5 and day similar to 90 after randomisation. Clinical assessments, randomisation to TXA or placebo and participant follow-up will be performed as per the TICH-2 trial protocol. Conclusion The TICH-2 MRI substudy will test whether TXA increases the incidence of new DWI-defined ischaemic lesions or reduces perihaematomal oedema or final ICH lesion volume in the context of SICH. Ethics and dissemination The TICH-2 trial obtained ethical approval from East Midlands -Nottingham 2 Research Ethics Committee (12/EM/0369) and an amendment to allow the TICH-2 MRI sub study was approved in April 2015 (amendment number SA02/15). All findings will be published in peer-reviewed journals. The primary outcome results will also be presented at a relevant scientific meeting.
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