Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial

Flaherty, Katie and Bath, Philip M.W. and Dineen, Robert and Law, Zhe and Scutt, Polly and Pocock, Stuart and Sprigg, Nikola (2017) Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial. Trials, 18 (1). 607/1-607/3. ISSN 1745-6215

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Abstract

Rationale

Aside from blood pressure lowering, treatment options for intracerebral haemorrhage remain limited and a proportion of patients will undergo early haematoma expansion with resultant significant morbidity and mortality. Tranexamic acid (TXA), an anti-fibrinolytic drug, has been shown to significantly reduce mortality in patients, who are bleeding following trauma, when given rapidly. TICH-2 is testing whether TXA is effective at improving outcome in spontaneous intracerebral haemorrhage (SICH).

Methods and design

TICH-2 is a pragmatic, phase III, prospective, double-blind, randomised placebo-controlled trial. Two thousand adult (aged ≥ 18 years) patients with an acute SICH, within 8 h of stroke onset, will be randomised to receive TXA or the placebo control. The primary outcome is ordinal shift of modified Rankin Scale score at day 90. Analyses will be performed using intention-to-treat.

Results

This paper and its attached appendices describe the statistical analysis plan (SAP) for the trial and were developed and published prior to database lock and unblinding to treatment allocation. The SAP includes details of analyses to be undertaken and unpopulated tables which will be reported in the primary and key secondary publications. The database will be locked in early 2018, ready for publication of the results later in the same year.

Discussion

The SAP details the analyses that will be done to avoid bias arising from prior knowledge of the study findings. The trial will determine whether TXA can improve outcome after SICH, which currently has no definitive therapy.

Trial registration

ISRCTN registry, ID: ISRCTN93732214. Registered on 17 January 2013.

Item Type: Article
Keywords: Hyperacute; Spontaneous intracerebral haemorrhage; Tranexamic acidRandomised trial; Placebo-controlled
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Clinical Neuroscience
Identification Number: 10.1186/s13063-017-2341-5
Depositing User: Eprints, Support
Date Deposited: 03 Jan 2018 10:56
Last Modified: 24 Jan 2018 06:30
URI: http://eprints.nottingham.ac.uk/id/eprint/48915

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