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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

Dineen RA 1 , Pszczolkowski S 1 , Flaherty K 2 , Law ZK 2 , Morgan PS 1 , Roberts I 3 Show all authors , Werring DJ 4 , Al-Shahi Salman R 5 , England T 6 , Bath PM 2 , Sprigg N 2

Affiliations 

  • 1 Radiological Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
  • 2 Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
  • 3 Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, UK
  • 4 Stroke Research Centre, University College London, London, UK
  • 5 Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
  • 6 Vascular Medicine, Division of Medical Sciences and GEM, University of Nottingham, Nottingham, UK
BMJ Open, 2018 02 03;8(2):e019930.
PMID: 29431141 DOI: 10.1136/bmjopen-2017-019930

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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