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

Rob A. Dineen*, Stefan Pszczolkowski, Katie Flaherty, Zhe K. Law, Paul S. Morgan, Ian Roberts, David J. Werring, Rustam Al Shahi Salman, Tim England, Philip M. Bath, Nikola Sprigg

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Article numbere019930
JournalBMJ Open
Volume8
Issue number2
DOIs
Publication statusPublished - 1 Feb 2018

Keywords

  • diffusion weighted imaging
  • hyperacute primary intracerebral haemorrhage
  • magnetic resonance imaging
  • perihaematomal oedema
  • tranexamic acid

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