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)
Metadaten
Author:Christian Ovesen, Janus Christian Jakobsen, Christian Gluud, Thorsten Steiner, Zhe Law, Katie Flaherty, Rob A. Dineen, Philip M. Bath, Nikola Sprigg, Hanne Christensen
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):License LogoCreative Commons - Namensnennung 4.0