TY  - JOUR
A1  - Ovesen, Christian
A1  - Jakobsen, Janus Christian
A1  - Gluud, Christian
A1  - Steiner, Thorsten
A1  - Law, Zhe
A1  - Flaherty, Katie
A1  - Dineen, Rob A.
A1  - Bath, Philip M.
A1  - Sprigg, Nikola
A1  - Christensen, Hanne
T1  - 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
T2  - BMC Research Notes
N2  - 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)
KW  - Intracerebral haemorrhage
KW  - Haematoma expansion
KW  - Tranexamic acid
KW  - Spot sign
KW  - Haemostatics
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/46734
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-467348
SN  - 1756-0500
N1  - 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.
VL  - 11
IS  - 1, Art. 379
SP  - 1
EP  - 8
PB  - Biomed Central
CY  - London
ER  -