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

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.; Sprigg, Nikola

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.

Citation

Dineen, R. A., Pszczolkowski, S., Flaherty, K., Law, Z. K., Morgan, P. S., Roberts, I., Werring, D., Al-Shahi Salman, R., England, T. J., Bath, P. M., & Sprigg, N. (in press). 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), Article e019930. https://doi.org/10.1136/bmjopen-2017-019930

• Journal Article Type: Article
• Acceptance Date: Dec 12, 2017
• Online Publication Date: Feb 1, 2018
• Deposit Date: Jan 5, 2018
• Publicly Available Date: Feb 1, 2018
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 8
• Issue: 2
• Article Number: e019930
• DOI: https://doi.org/10.1136/bmjopen-2017-019930
• Keywords: hyperacute primary intracerebral haemorrhage; tranexamic acid; magnetic resonance imaging; diffusion weighted imaging; perihaematomal oedema
• Public URL: https://nottingham-repository.worktribe.com/output/962650
• Publisher URL: http://bmjopen.bmj.com/content/8/2/e019930
• Contract Date: Jan 5, 2018