Evidence map›Paper›PMID 21724564›Full record

Trial reportBMJ (Clinical research ed.)2011

Effect of tranexamic acid in traumatic brain injury: a nested randomised, placebo controlled trial (CRASH-2 Intracranial Bleeding Study).

CRASH-2 Collaborators, Intracranial Bleeding Study

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05713630 (TRACE STUDY), which is not on this map. Cited by 60 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 11 pooled it
7.8field-weighted citation impact, top 1% 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.

NCT05713630 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma

TypeinterventionalSponsorUnity Health TorontoRan2026 to 2030Enrolled130ConditionsSubdural HematomaArmsTranexamic acid (TXA), Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 11 syntheses or guidelines pooled it, 200 citations in OpenAlex.

  1. Pooled it
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  3. Systemic hemostatic agents initiated in trauma patients in the pre-hospital setting: a systematic review.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2023
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  9. Antifibrinolytic drugs for acute traumatic injury.The Cochrane database of systematic reviews · 2015
    Pooled it
  10. Pooled it
  11. Tranexamic acid for upper gastrointestinal bleeding.The Cochrane database of systematic reviews · 2014
    Pooled it
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  14. Benefits of the tranexamic acid in head trauma with no extracranial bleeding: a prospective follow-up of 180 patients.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2019
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  17. The effect of tranexamic acid in traumatic brain injury: A randomized controlled trial.Chinese journal of traumatology = Zhonghua chuang shang za zhi · 2017
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

1 author.

CRASH-2 Collaborators, Intracranial Bleeding Study

Funding

Department of Health 09/102/01Department of Health HTA/09/102/01Medical Research Council G1002605Medical Research Council G108/613
6 · The paper itself

Abstract

objectiveTo assess the effect of tranexamic acid (which reduces bleeding in surgical patients and reduces mortality due to bleeding in trauma patients) on intracranial haemorrhage in patients with traumatic brain injury.

methodsA nested, randomised, placebo controlled trial. All investigators were masked to treatment allocation. All analyses were by intention to treat. Patients 270 adult trauma patients with, or at risk of, significant extracranial bleeding within 8 hours of injury, who also had traumatic brain injury.

interventionsPatients randomly allocated to tranexamic acid (loading dose 1 g over 10 minutes, then infusion of 1 g over 8 hours) or matching placebo.

main outcome measuresIntracranial haemorrhage growth (measured by computed tomography) between hospital admission and then 24-48 hours later, with adjustment for Glasgow coma score, age, time from injury to the scans, and initial haemorrhage volume.

resultsOf the 133 patients allocated to tranexamic acid and 137 allocated to placebo, 123 (92%) and 126 (92%) respectively provided information on the primary outcome. All patients provided information on clinical outcomes. The mean total haemorrhage growth was 5.9 ml (SD 26.8) and 8.1 mL (SD 29.2) in the tranexamic acid and placebo groups respectively (adjusted difference -3.8 mL (95% confidence interval -11.5 to 3.9)). New focal cerebral ischaemic lesions occurred in 6 (5%) patients in the tranexamic acid group versus 12 (9%) in the placebo group (adjusted odds ratio 0.51 (95% confidence interval 0.18 to 1.44)). There were 14 (11%) deaths in the tranexamic acid group and 24 (18%) in the placebo group (adjusted odds ratio 0.47 (0.21 to 1.04)).

conclusionsThis trial shows that neither moderate benefits nor moderate harmful effects of tranexamic acid in patients with traumatic brain injury can be excluded. However, the analysis provides grounds for further clinical trials evaluating the effect of tranexamic acid in this population. Trial registration ISRCTN86750102.

Indexed as

AdultAntifibrinolytic AgentsBrain InjuriesCase-Control StudiesFemaleGlasgow Coma ScaleHumansIntracranial HemorrhagesMaleSubarachnoid HemorrhageTomography, X-Ray ComputedTranexamic AcidTreatment OutcomeAntifibrinolytic AgentsTranexamic Acid

Identifiers

PMID21724564
PMCPMC3128457
OpenAlexW2346022404

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.