@article { , title = {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}, 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.}, doi = {10.1136/bmjopen-2017-019930}, eissn = {2044-6055}, issue = {2}, journal = {BMJ Open}, publicationstatus = {Published}, publisher = {BMJ Publishing Group}, url = {https://nottingham-repository.worktribe.com/output/962650}, volume = {8}, keyword = {hyperacute primary intracerebral haemorrhage, tranexamic acid, magnetic resonance imaging, diffusion weighted imaging, perihaematomal oedema}, author = {Dineen, Robert A. and Pszczolkowski, Stefan and Flaherty, Katie and Law, Zhe Kang and Morgan, Paul S. and Roberts, Ian and Werring, David and Al-Shahi Salman, Rustam and England, Timothy J. and Bath, Philip M.W. and Sprigg, Nikola} }