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 ~5 and day ~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.
Trial registration number ISRCTN93732214; Pre-results.
- hyperacute primary intracerebral haemorrhage
- tranexamic acid
- magnetic resonance imaging
- diffusion weighted imaging
- perihaematomal oedema
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Contributors RAD, KF, PSM, IR, DJW, RAS, TE, PMB and NS designed the study and were coapplicants for funding. SP designed and performed the image analyses. KF designed and performed the statistical analyses. RAD, SP, ZKL, KF and NS drafted the manuscript. All authors reviewed and commented on the manuscript.
Funding This work was supported by the British Heart Foundation [grant number PG/14/96/31262] and Health Technology Assessment Programme [grant number 11_129_109].
Competing interests None declared.
Patient consent Not required.
Ethics approval Nottingham-2 Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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