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 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. Trial registration: ISRCTN93732214 (http://www.isrctn.com)
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| Author: | Christian Ovesen, Janus Christian Jakobsen, Christian Gluud, Thorsten SteinerORCiDGND, Zhe Law, Katie Flaherty, Rob A. Dineen, Philip M. Bath, Nikola Sprigg, Hanne Christensen |
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| URN: | urn:nbn:de:hebis:30:3-467348 |
| DOI: | https://doi.org/10.1186/s13104-018-3481-8 |
| ISSN: | 1756-0500 |
| Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/29895329 |
| Parent Title (English): | BMC Research Notes |
| Publisher: | Biomed Central |
| Place of publication: | London |
| Document Type: | Article |
| Language: | English |
| Year of Completion: | 2018 |
| Date of first Publication: | 2018/06/13 |
| Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
| Release Date: | 2018/06/19 |
| Tag: | Haematoma expansion; Haemostatics; Intracerebral haemorrhage; Spot sign; Tranexamic acid |
| Volume: | 11 |
| Issue: | 1, Art. 379 |
| Page Number: | 8 |
| First Page: | 1 |
| Last Page: | 8 |
| Note: | Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| HeBIS-PPN: | 434236330 |
| Institutes: | Medizin / Medizin |
| Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
| Sammlungen: | Universitätspublikationen |
| Licence (German): |  Creative Commons - Namensnennung 4.0 |
