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Dineen, Robert A., Pszczolkowski, Stefan, Flaherty, Katie, Law, Zhe Kang, Morgan, Paul S., Roberts, Ian, Werring, David, Al-Shahi Salman, Rustam, England, Timothy J., Bath, Philip M.W. and Sprigg, Nikola (2018) Does tranexamic acid lead to changes in MRI-measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? An MRI sub-study nested within the double-blind randomised controlled TICH-2 trial. BMJ Open, 8 (2). e019930/1-e019930/7. ISSN 2044-6055

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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 sub-study nested within the double-blind randomised controlled TICH-2 trial (ISRCTN93732214).

Setting: International multi-centre 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 hyperintense lesions in the TXA group with 5% significance, 80% power and 5% imaging data rejection.

Interventions: TICH-2 MRI sub-study 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 sub-study will test whether TXA increases the incidence of new DWI-defined ischemic lesions or reduces perihaematomal oedema or final ICH lesion volume in the context of SICH.

Item Type:	Article
RIS ID:	https://nottingham-repository.worktribe.com/output/962650
Keywords:	hyperacute primary intracerebral haemorrhage; tranexamic acid; magnetic resonance imaging; diffusion weighted imaging; perihaematomal oedema
Schools/Departments:	University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Clinical Neuroscience University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Medical Sciences and Graduate Entry Medicine
Identification Number:	https://doi.org/10.1136/bmjopen-2017-019930
Depositing User:	Eprints, Support
Date Deposited:	05 Jan 2018 14:42
Last Modified:	04 May 2020 19:52
URI:	https://eprints.nottingham.ac.uk/id/eprint/48960

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