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

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

doi:10.1186/s13104-018-3481-8

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

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

Department of Clinical Medicine

4 Citations (Scopus)

18 Downloads (Pure)

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. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).

Original language	English
Article number	379
Journal	BMC Research Notes
Volume	11
Issue number	1
Pages (from-to)	1-8
Number of pages	8
ISSN	1756-0500
DOIs	https://doi.org/10.1186/s13104-018-3481-8
Publication status	Published - 13 Jun 2018

Keywords

Antifibrinolytic Agents/administration & dosage
Cerebral Hemorrhage/diagnostic imaging
Data Interpretation, Statistical
Disease Progression
Hematoma/diagnostic imaging
Humans
Outcome Assessment (Health Care)/statistics & numerical data
Tranexamic Acid/administration & dosage

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Ovesen, C., Jakobsen, J. C., Gluud, C., Steiner, T., Law, Z., Flaherty, K., Dineen, R. A., 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(1), 1-8. Article 379. https://doi.org/10.1186/s13104-018-3481-8

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 et al.
In: BMC Research Notes, Vol. 11, No. 1, 379, 13.06.2018, p. 1-8.

Research output: Contribution to journal › Journal article › Research › peer-review

Ovesen, C, Jakobsen, JC, Gluud, C, Steiner, T, Law, Z, Flaherty, K, Dineen, RA, Bath, PM, 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, vol. 11, no. 1, 379, pp. 1-8. https://doi.org/10.1186/s13104-018-3481-8

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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. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).",

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author = "Christian Ovesen and Jakobsen, {Janus Christian} and Christian Gluud and Thorsten Steiner and Zhe Law and Katie Flaherty and Dineen, {Rob A} and Bath, {Philip M} and Nikola Sprigg and Hanne Christensen",

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AU - Jakobsen, Janus Christian

AU - Gluud, Christian

AU - Steiner, Thorsten

AU - Law, Zhe

AU - Flaherty, Katie

AU - Dineen, Rob A

AU - Bath, Philip M

AU - Sprigg, Nikola

AU - Christensen, Hanne

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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 ).

AB - 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 ).

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