Evidence map›Paper›PMID 39095919›Full record

ArticleTrials2024

Efficacy of tranexamic acid versus placebo in reducing blood loss during burn excisional surgery: a multi-center, double-blind, parallel, randomized placebo-controlled clinical trial (TRANEX).

R K Gigengack, J Slob, A Meij-de Vries, E Bosma, S A Loer, J S H A Koopman, C H van der Vlies

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05507983 (Tranexamic Acid During Excisional Burn Surgery), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT05507983 phase3unknown statusnot on this map

Tranexamic Acid During Excisional Burn Surgery

TypeinterventionalSponsorMaasstad HospitalRan2021 to 2025Enrolled96ConditionsBurns, Blood Loss, Surgical, Blood Loss, Tranexamic AcidArmsTranexamic acid, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

R K Gigengack *Department of Intensive Care, Amsterdam UMC Location Vrije Universiteit, Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands. r.gigengack@amsterdamumc.nl.ORCID http://orcid.org/0000-0003-2162-0674
J Slob *Departments of Trauma and Burn Surgery, Maasstad Hospital, Rotterdam, the Netherlands.
A Meij-de VriesDepartment of Surgery, Red Cross Hospital, Beverwijk, The Netherlands.
E BosmaDepartment of Surgery, Martini Hospital, Groningen, The Netherlands.
S A LoerDepartment of Anesthesiology, Amsterdam UMC Location Vrije Universiteit, Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.
J S H A KoopmanDepartment of Anesthesiology, Maasstad Hospital, Rotterdam, the Netherlands.
C H van der VliesDepartments of Trauma and Burn Surgery, Maasstad Hospital, Rotterdam, the Netherlands.

Funding

Nederlandse Brandwonden Stichting WO 19.102
6 · The paper itself

Abstract

backgroundDespite an increase in knowledge, blood loss during burn excisional surgery remains a major challenge and is an independent predictor of mortality. During burn surgery, limited measures are available to control the bleeding. Increased fibrinolysis could be one of the contributing factors of blood loss during burn excisional surgery. Tranexamic acid inhibits the fibrinolytic response, and a small body of evidence shows positive effects of tranexamic acid on the volume of blood loss.

methodsThe main objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces blood loss and (2) to investigate the changes in coagulation after burn trauma and during burn excisional surgery. This study is a multicenter double-blind randomized clinical trial in patients scheduled for burn excisional surgery within the Dutch burn centers. All adult patients scheduled for burn surgery with an expected blood loss of ≥ 250 are eligible for inclusion in this study. The study is powered on a blood loss reduction of 25% in the intervention group. In total, 95 subjects will be included. The intervention group will receive 1500 mg tranexamic acid versus placebo in the other group. Primary endpoint is reduction of blood loss. Secondary endpoints include occurrence of fibrinolysis during surgery, graft take of the split skin graft, and differences in coagulation and blood clot formation. DISCUSSION: This protocol of a randomized controlled trial aims to investigate the efficacy of tranexamic acid in reducing blood loss during burn excisional surgery. Furthermore, this study aims to clarify the coagulation status after burn trauma and during the surgical process.

trial registrationEudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).

Indexed as

Antifibrinolytic AgentsBlood Loss, SurgicalBurnsMulticenter Studies as TopicRandomized Controlled Trials as TopicTranexamic AcidAdultBlood CoagulationDouble-Blind MethodFemaleFibrinolysisHumansMaleNetherlandsTreatment OutcomeAntifibrinolytic AgentsTranexamic AcidBlood lossBurnsExcisional surgeryFibrinolysisTranexamic acid

Identifiers

PMID39095919
PMCPMC11297649

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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.