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Clinical Trial
. 2017 Dec 20;18(1):607.
doi: 10.1186/s13063-017-2341-5.

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

Katie Flaherty  1 , Philip M Bath  1 , Robert Dineen  2 , Zhe Law  1   3 , Polly Scutt  1 , Stuart Pocock  4 , Nikola Sprigg  5 ; TICH-2 investigators
Affiliations
Clinical Trial

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

Katie Flaherty et al. Trials. .

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.

Keywords: Hyperacute; Placebo-controlled; Randomised trial; Spontaneous intracerebral haemorrhage; Tranexamic acid.

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Conflict of interest statement

Ethics approval and consent to participate

The study received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) on 23 October 2012, the Research Ethics Committee (REC) on 23 November 2012, and the respective National Health Service Research and Development (R&D) department on 15 February 2013. Consent was obtained from all participants prior to enrolment into the trial. Ethics approval was obtained to allow full informed consent or verbal assent (using a Brief Information Sheet) followed by full written consent at a later date.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

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