Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial
Objective We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared...
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| Format: | Article |
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BioMed Central
2018
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| Online Access: | https://eprints.nottingham.ac.uk/52892/ |
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| author | Ovesen, Christian Jakobsen, Janus Christian Gluud, Christian Steiner, Thorsten Law, Zhe Flaherty, Katie Dineen, Robert Bath, Philip M.W. Sprigg, Nikola Christensen, Hanne |
| author_facet | Ovesen, Christian Jakobsen, Janus Christian Gluud, Christian Steiner, Thorsten Law, Zhe Flaherty, Katie Dineen, Robert Bath, Philip M.W. Sprigg, Nikola Christensen, Hanne |
| author_sort | Ovesen, Christian |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Objective
We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants’ spot sign status.
Results
Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. |
| first_indexed | 2025-11-14T20:26:03Z |
| format | Article |
| id | nottingham-52892 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:26:03Z |
| publishDate | 2018 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-528922020-05-04T19:40:24Z https://eprints.nottingham.ac.uk/52892/ Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial Ovesen, Christian Jakobsen, Janus Christian Gluud, Christian Steiner, Thorsten Law, Zhe Flaherty, Katie Dineen, Robert Bath, Philip M.W. Sprigg, Nikola Christensen, Hanne Objective We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants’ spot sign status. Results Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. BioMed Central 2018-06-13 Article PeerReviewed Ovesen, Christian, Jakobsen, Janus Christian, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Robert, Bath, Philip M.W., Sprigg, Nikola and Christensen, Hanne (2018) Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial. BMC Research Notes, 11 . 379/1-379/8. ISSN 1756-0500 Intracerebral haemorrhage; Haematoma expansion; Tranexamic acid; Spot sign; Haemostatics http://dx.doi.org/10.1186/s13104-018-3481-8 doi:10.1186/s13104-018-3481-8 doi:10.1186/s13104-018-3481-8 |
| spellingShingle | Intracerebral haemorrhage; Haematoma expansion; Tranexamic acid; Spot sign; Haemostatics Ovesen, Christian Jakobsen, Janus Christian Gluud, Christian Steiner, Thorsten Law, Zhe Flaherty, Katie Dineen, Robert Bath, Philip M.W. Sprigg, Nikola Christensen, Hanne Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial |
| title | Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial |
| title_full | Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial |
| title_fullStr | Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial |
| title_full_unstemmed | Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial |
| title_short | Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial |
| title_sort | prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the tich-2 trial |
| topic | Intracerebral haemorrhage; Haematoma expansion; Tranexamic acid; Spot sign; Haemostatics |
| url | https://eprints.nottingham.ac.uk/52892/ https://eprints.nottingham.ac.uk/52892/ https://eprints.nottingham.ac.uk/52892/ |