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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

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...

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Main Authors: Ovesen, Christian (Author) , Jakobsen, Janus Christian (Author) , Gluud, Christian (Author) , Steiner, Thorsten (Author) , Law, Zhe (Author) , Flaherty, Katie (Author) , Dineen, Rob A. (Author) , Bath, Philip M. (Author) , Sprigg, Nikola (Author) , Christensen, Hanne (Author)
Format: Article (Journal)
Language:English
Published: 13 June 2018
In: BMC Research Notes
Year: 2018, Volume: 11, Issue: 1
ISSN:1756-0500
DOI:10.1186/s13104-018-3481-8
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1186/s13104-018-3481-8
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Author Notes:Christian Ovesen, Janus Christian Jakobsen, Christian Gluud, Thorsten Steiner, Zhe Law, Katie Flaherty, Rob A. Dineen, Philip M. Bath, Nikola Sprigg, Hanne Christensen
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Summary: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.
Item Description:Gesehen am 12.03.2020
Physical Description:Online Resource
ISSN:1756-0500
DOI:10.1186/s13104-018-3481-8

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