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

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.

Citation

Ovesen, C., Jakobsen, J. C., Gluud, C., Steiner, T., Law, Z., Flaherty, K., Dineen, R., Bath, P. M., Sprigg, N., & Christensen, H. (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, Article 379. https://doi.org/10.1186/s13104-018-3481-8

• 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
• Contract Date: Jul 11, 2018