%0 Journal Article
%T Does tranexamic acid lead to changes in MRI measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? Protocol for a MRI substudy nested within the double-blind randomised controlled TICH-2 trial
%A David J Werring
%A Ian Roberts
%A Katie Flaherty
%A Nikola Sprigg
%A Paul S Morgan
%A Philip M Bath
%A Rob A Dineen
%A Rustam Al-Shahi Salman
%A Stefan Pszczolkowski
%A Tim England
%A Zhe K Law
%J -
%D 2018
%R 10.1136/bmjopen-2017-019930
%X 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][1]).

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][1]; Pre-results.

 [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN9373221
%U https://bmjopen.bmj.com/content/8/2/e019930