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 ISRCTN93732214 ISRCTN

Christian Ovesen, Janus Christian Jakobsen, Christian Gluud, Thorsten Steiner, Zhe Law, Katie Flaherty, Rob A. Dineen, Philip M. Bath, Nikola Sprigg, Hanne Christensen

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstrakt

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)

OriginalsprogEngelsk
Artikelnummer379
TidsskriftBMC Research Notes
Vol/bind11
Udgave nummer1
DOI
StatusUdgivet - 13 jun. 2018

Fingeraftryk Udforsk hvilke forskningsemner '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 ISRCTN93732214 ISRCTN' indeholder.

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