Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial
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...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Published: |
BioMed Central
2017
|
| Subjects: | |
| Online Access: | https://eprints.nottingham.ac.uk/48915/ |
| _version_ | 1848797878233858048 |
|---|---|
| author | Flaherty, Katie Bath, Philip M.W. Dineen, Robert Law, Zhe Scutt, Polly Pocock, Stuart Sprigg, Nikola |
| author_facet | Flaherty, Katie Bath, Philip M.W. Dineen, Robert Law, Zhe Scutt, Polly Pocock, Stuart Sprigg, Nikola |
| author_sort | Flaherty, Katie |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:10:52Z |
| format | Article |
| id | nottingham-48915 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:10:52Z |
| publishDate | 2017 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-489152020-05-04T19:23:15Z https://eprints.nottingham.ac.uk/48915/ Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial Flaherty, Katie Bath, Philip M.W. Dineen, Robert Law, Zhe Scutt, Polly Pocock, Stuart Sprigg, Nikola 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. BioMed Central 2017-12-20 Article PeerReviewed Flaherty, Katie, Bath, Philip M.W., Dineen, Robert, Law, Zhe, Scutt, Polly, 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 Hyperacute; Spontaneous intracerebral haemorrhage; Tranexamic acidRandomised trial; Placebo-controlled https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2341-5 doi:10.1186/s13063-017-2341-5 doi:10.1186/s13063-017-2341-5 |
| spellingShingle | Hyperacute; Spontaneous intracerebral haemorrhage; Tranexamic acidRandomised trial; Placebo-controlled Flaherty, Katie Bath, Philip M.W. Dineen, Robert Law, Zhe Scutt, Polly Pocock, Stuart Sprigg, Nikola Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial |
| title | Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial |
| title_full | Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial |
| title_fullStr | Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial |
| title_full_unstemmed | Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial |
| title_short | Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial |
| title_sort | statistical analysis plan for the ‘tranexamic acid for hyperacute primary intracerebral haemorrhage’ (tich-2) trial |
| topic | Hyperacute; Spontaneous intracerebral haemorrhage; Tranexamic acidRandomised trial; Placebo-controlled |
| url | https://eprints.nottingham.ac.uk/48915/ https://eprints.nottingham.ac.uk/48915/ https://eprints.nottingham.ac.uk/48915/ |