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

Autor: Philip M.W. Bath, Robert A. Dineen, Katie Flaherty, Zhe Kang Law, Christian Ovesen, Christian Gluud, Thorsten Steiner, Janus Christian Jakobsen, Hanne Christensen, Nikola Sprigg
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Tranexamic acid
Outcome Assessment (Health Care)/statistics & numerical data
lcsh:Medicine
Subgroup analysis
Computed tomography
Cerebral Hemorrhage/diagnostic imaging
Tranexamic Acid/administration & dosage
Placebo
General Biochemistry
Genetics and Molecular Biology
03 medical and health sciences
Hematoma/diagnostic imaging
0302 clinical medicine
Outcome Assessment
Health Care
medicine
Humans
ddc:610
030212 general & internal medicine
Symptom onset
lcsh:Science (General)
Trial registration
Haemostatics
lcsh:QH301-705.5
Cerebral Hemorrhage
Computed tomography angiography
Hematoma
medicine.diagnostic_test
business.industry
lcsh:R
General Medicine
Haematoma expansion
Antifibrinolytic Agents
Research Note
Antifibrinolytic Agents/administration & dosage
lcsh:Biology (General)
Intracerebral haemorrhage
Anesthesia
Data Interpretation
Statistical
Spot sign
Disease Progression
business
030217 neurology & neurosurgery
lcsh:Q1-390
medicine.drug
Zdroj: 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, vol. 11, no. 1, 379, pp. 1-8 . https://doi.org/10.1186/s13104-018-3481-8
BMC Research Notes
BMC Research Notes, Vol 11, Iss 1, Pp 1-8 (2018)
ISSN: 1756-0500
DOI: 10.1186/s13104-018-3481-8
Popis: 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)
Databáze: OpenAIRE
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