Evidence map›Paper›PMID 29262841›Full record

Trial reportTrials2017

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

Katie Flaherty, Philip M Bath, Robert Dineen, Zhe Law, Polly Scutt, Stuart Pocock, Nikola Sprigg, TICH-2 investigators

Open access · goldAbstract readClinical Trial, Phase IIIPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Katie FlahertyStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK.ORCID http://orcid.org/0000-0002-8728-2199
Philip M BathStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK.
Robert DineenImaging Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Zhe LawStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK.
Polly ScuttStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK.
Stuart PocockDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Nikola SpriggStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK. nikola.sprigg@nottingham.ac.uk.
TICH-2 investigators
University of Nottingham · GBNottingham City Hospital · GB

Funding

Department of Health 11/129/109Health Technology Assessment Programme 11_129_109
6 · The paper itself

Abstract

rationaleAside 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

designTICH-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.

resultsThis 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 registrationISRCTN registry, ID: ISRCTN93732214 . Registered on 17 January 2013.

Indexed as

Antifibrinolytic AgentsCerebral HemorrhageClinical ProtocolsData Interpretation, StatisticalDisability EvaluationDouble-Blind MethodHumansIntention to Treat AnalysisLogistic ModelsProspective StudiesResearch DesignTime FactorsTranexamic AcidTreatment OutcomeAntifibrinolytic AgentsTranexamic AcidHyperacutePlacebo-controlledRandomised trialSpontaneous intracerebral haemorrhageTranexamic acid

Identifiers

PMID29262841
PMCPMC5738041
OpenAlexW2780149673

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.