Evidence map›Paper›PMID 34910219›Full record

Trial reportEuropean journal of trauma and emergency surgery : official publication of the European Trauma Society2022

Efficacy and safety of the second in-hospital dose of tranexamic acid after receiving the prehospital dose: double-blind randomized controlled clinical trial in a level 1 trauma center.

Ayman El-Menyar, Khalid Ahmed, Suhail Hakim, Ahad Kanbar, Saji Mathradikkal, Tariq Siddiqui, Hisham Jogol, Basil Younis, Ibrahim Taha, Ismail Mahmood and 10 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of trauma and emergency surgery : official publication of the European Trauma Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03846973 (Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid Administration of Trauma Patients), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 22% 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.

NCT03846973 phase3completednot on this map

Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid Administration of Trauma Patients: A Randomized, Double-blind Controlled Clinical Trial

TypeinterventionalSponsorHamad Medical CorporationRan2018 to 2021Enrolled220ConditionsTranexamic AcidArmsTranexamic Acid, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 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

20 authors at 3 institutions in 2 countries.

Ayman El-MenyarTrauma & Vascular Surgery, Clinical Research, Hamad General Hospital, Hamad Medical Corporation (HMC), P.O Box 3050, Doha, Qatar. aymanco65@yahoo.com.ORCID http://orcid.org/0000-0003-2584-953X
Khalid AhmedDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Suhail HakimDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Ahad KanbarDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Saji MathradikkalDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Tariq SiddiquiDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Hisham JogolDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Basil YounisDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Ibrahim TahaDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Ismail MahmoodDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Ahmed AjajDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Sajid AtiqueDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Abubaker AlaiebDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Ahmed Abdel-Aziz BaheyTrauma Surgery, Clinical Pharmacy, Hamad General Hospital, HMC, Doha, Qatar.
Mohammad AsimTrauma & Vascular Surgery, Clinical Research, Hamad General Hospital, Hamad Medical Corporation (HMC), P.O Box 3050, Doha, Qatar.
Guillaume AlinierHamad Medical Corporation Ambulance Service, Medical City, HMC, Doha, Qatar.
Nicholas R CastleHamad Medical Corporation Ambulance Service, Medical City, HMC, Doha, Qatar.
Ahammed MekkodathilTrauma & Vascular Surgery, Clinical Research, Hamad General Hospital, Hamad Medical Corporation (HMC), P.O Box 3050, Doha, Qatar.
Sandro RizoliDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Hassan Al-ThaniDepartment of Surgery, Trauma Surgery, Hamad General Hospital, HMC, Doha, Qatar.
Hamad General Hospital · QAHamad Medical Corporation · QAUniversity of Hertfordshire · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrehospital administration of tranexamic acid (TXA) to injured patients is increasing worldwide. However, optimal TXA dose and need of a second infusion on hospital arrival remain undetermined. We investigated the efficacy and safety of the second in-hospital dose of TXA in injured patients receiving 1 g of TXA in the prehospital setting. We hypothesized that a second in-hospital dose of TXA improves survival of trauma patients.

methodsA prospective, double-blind, placebo-controlled randomized, clinical trial included adult trauma patients receiving 1 g of TXA in the prehospital settings. Patients were then blindly randomized to Group I (second 1-g TXA) and Group II (placebo) on hospital arrival. The primary outcome was 24-h (early) and 28-day (late) mortality. Secondary outcomes were thromboembolic events, blood transfusions, hospital length of stay (HLOS) and organs failure (MOF).

resultsA total of 220 patients were enrolled, 110 in each group. The TXA and placebo groups had a similar early [OR 1.000 (0.062-16.192); p = 0.47] and late mortality [OR 0.476 (95% CI 0.157-1.442), p = 0.18].The cause of death (n = 15) was traumatic brain injury (TBI) in 12 patients and MOF in 3 patients. The need for blood transfusions in the first 24 h, number of transfused blood units, HLOS, thromboembolic events and multiorgan failure were comparable in the TXA and placebo groups. In seriously injured patients (injury severity score > 24), the MTP activation was higher in the placebo group (31.3% vs 11.10%, p = 0.13), whereas pulmonary embolism (6.9% vs 2.9%, p = 0.44) and late mortality (27.6% vs 14.3%, p = 0.17) were higher in the TXA group but did not reach statistical significance.

conclusionThe second TXA dose did not change the mortality rate, need for blood transfusion, thromboembolic complications, organ failure and HLOS compared to a single prehospital dose and thus its routine administration should be revisited in larger and multicenter studies.

trial registrationClinicalTrials.gov Identifier: NCT03846973.

Indexed as

Antifibrinolytic AgentsTranexamic AcidAdultHospitalsHumansProspective StudiesTrauma CentersAntifibrinolytic AgentsTranexamic AcidBleedingPrehospitalRandomized controlled trialTranexamic acidTrauma

Identifiers

PMID34910219
PMCPMC9360064
OpenAlexW4200557874

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.