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
Full text not available from this repository.
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: |
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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