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
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 oe...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
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BMJ Publishing Group Ltd
2018
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| Online Access: | https://eprints.nottingham.ac.uk/48960/ |
| _version_ | 1848797888921993216 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Dineen, Robert A. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:11:02Z |
| format | Article |
| id | nottingham-48960 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:11:02Z |
| publishDate | 2018 |
| publisher | BMJ Publishing Group Ltd |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-489602020-05-04T19:52:26Z https://eprints.nottingham.ac.uk/48960/ 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 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. BMJ Publishing Group Ltd 2018-02 Article PeerReviewed 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 hyperacute primary intracerebral haemorrhage; tranexamic acid; magnetic resonance imaging; diffusion weighted imaging; perihaematomal oedema http://bmjopen.bmj.com/content/8/2/e019930 doi:10.1136/bmjopen-2017-019930 doi:10.1136/bmjopen-2017-019930 |
| spellingShingle | hyperacute primary intracerebral haemorrhage; tranexamic acid; magnetic resonance imaging; diffusion weighted imaging; perihaematomal oedema 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 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 |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | hyperacute primary intracerebral haemorrhage; tranexamic acid; magnetic resonance imaging; diffusion weighted imaging; perihaematomal oedema |
| url | https://eprints.nottingham.ac.uk/48960/ https://eprints.nottingham.ac.uk/48960/ https://eprints.nottingham.ac.uk/48960/ |