Evidence map›Paper›PMID 28143564›Full record

Trial reportTrials2017

Tranexamic acid in bleeding trauma patients: an exploration of benefits and harms.

Ian Roberts, Phil Edwards, David Prieto, Miland Joshi, Abda Mahmood, Katharine Ker, Haleema Shakur

Registry-linked trialAbstract readRandomized Controlled Trial
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. It is linked to trial NCT00375258 (A Large Randomised Placebo Controlled Trial Among Trauma Patients With, or at Risk of, Significant Haemorrhage, of the Effects of Antifibrinolytic Treatment on Death and Transfusion Requirement), which is not on this map. Cited by 21 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT00375258 phase3completednot on this map

A Large Randomised Placebo Controlled Trial Among Trauma Patients With, or at Risk of, Significant Haemorrhage, of the Effects of Antifibrinolytic Treatment on Death and Transfusion Requirement

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2005 to 2010Enrolled20,211ConditionsHemorrhageArmsTranexamic acid, Sodium Chloride 0.9%
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  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
    Pooled it
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  7. Trial
  8. 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
    Trial
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  12. Observational
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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

7 authors.

Ian RobertsClinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Ian.Roberts@lshtm.ac.uk.
Phil EdwardsClinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
David PrietoClinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Miland JoshiClinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Abda MahmoodClinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Katharine KerClinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Haleema ShakurClinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.

Funding

Department of Health 11/01/04Department of Health HTA/14/190/01Medical Research Council MR/M009211/1
6 · The paper itself

Abstract

backgroundThe CRASH-2 trial showed that tranexamic acid (TXA) administration reduces mortality in bleeding trauma patients. However, the effect appeared to depend on how soon after injury TXA treatment was started. Treatment within 3 h reduced bleeding deaths whereas treatment after 3 h increased the risk. We examine how patient characteristics vary by time to treatment and explore whether any such variations explain the time-dependent treatment effect.

methodsExploratory analysis were carried out, including per-protocol analyses, of data from the CRASH-2 trial, a randomised placebo-controlled trial of the effect of TXA on mortality in 20,211 trauma patients with, or at risk of, significant bleeding. We examine how patient characteristics (age, type of injury, presence or absence of head injury, Glasgow coma scale (GCS), systolic blood pressure and capillary refill time) vary with time to treatment and use univariable (restriction) and multivariable methods to examine whether any such variations explain the time-dependent effect of TXA. If not explained by differences in patient characteristics, we planned to conduct separate prespecified subgroup analyses for the early benefit and late harm.

resultsThere was no substantial variation in age or capillary refill by time to treatment. However, the proportion of patients with blunt trauma, the proportion with head injury and mean systolic blood pressure increased as time to treatment increased. Mean GCS decreased as time to treatment increased. Analyses restricted to patients with blunt trauma, those without head injury and those with a systolic blood pressure <100 mmHg showed that these characteristics did not explain the time-dependent treatment effect. In a multivariable analysis the interaction with time to treatment remained highly significant (p < 0.0001). Separate subgroup analyses that examine how the benefits of early TXA treatment and the harms of late TXA treatment vary by systolic blood pressure (≤75, 76-89, >89 mmHg); GCS (severe 3-8, moderate 9-12, mild 13-15); and type of injury (penetrating versus blunt) showed no significant heterogeneity.

conclusionsThe time-dependent effect of TXA in bleeding trauma patients is not explained by the type of injury, the presence or absence of head injury or systolic blood pressure. When given within 3 h of injury, TXA reduces death due to bleeding regardless of type of injury, GCS or blood pressure.

trial registrationClinicalTrials.gov, NCT00375258 . Registered on 11 September 2006.

Indexed as

Time-to-TreatmentAge FactorsAntifibrinolytic AgentsBlood PressureChi-Square DistributionFibrinolysisGlasgow Coma ScaleHemorrhageHumansLogistic ModelsMultivariate AnalysisOdds RatioRisk AssessmentRisk FactorsTime FactorsTranexamic AcidAntifibrinolytic AgentsTranexamic Acid

Identifiers

PMID28143564
PMCPMC5282847

What OpenQuestion holds

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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.