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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

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 Thumbnail


Authors

Christian Ovesen

Janus Christian Jakobsen

Christian Gluud

Thorsten Steiner

Zhe Law

Katie Flaherty

ROBERT DINEEN rob.dineen@nottingham.ac.uk
Professor of Neuroradiology

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

Hanne Christensen



Abstract

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.

Journal Article Type Article
Acceptance Date Jun 5, 2018
Publication Date Jun 13, 2018
Deposit Date Jul 11, 2018
Publicly Available Date Jul 11, 2018
Journal BMC Research Notes
Electronic ISSN 1756-0500
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 11
Article Number 379
DOI https://doi.org/10.1186/s13104-018-3481-8
Keywords Intracerebral haemorrhage; Haematoma expansion; Tranexamic acid; Spot sign; Haemostatics
Public URL https://nottingham-repository.worktribe.com/output/937788
Publisher URL http://dx.doi.org/10.1186/s13104-018-3481-8

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Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan- a statistic.pdf (1 Mb)
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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