Evidence map›Paper›PMID 36243576›Full record

Trial reportBritish journal of anaesthesia2022

Tranexamic acid dose-response relationship for antifibrinolysis in postpartum haemorrhage during Caesarean delivery: TRACES, a double-blind, placebo-controlled, multicentre, dose-ranging biomarker study.

Anne-Sophie Ducloy-Bouthors, Sixtine Gilliot, Maeva Kyheng, David Faraoni, Alexandre Turbelin, Hawa Keita-Meyer, Agnès Rigouzzo, Gabriela Moyanotidou, Benjamin Constant, Francoise Broisin and 12 more

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

Trial report in British journal of anaesthesia, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02797119 (Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT02797119 phase4completednot on this map

Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk

TypeinterventionalSponsorUniversity Hospital, LilleRan2016 to 2021Enrolled225ConditionsPregnancy Complications, HemorrhageArmstranexamic acid 1 g (TA1), tranexamic acid 0.5 g (TA1/2), Saline Solution (TA0)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Peripartum Haemorrhage: Haemostatic Aspects of the Updated Peripartum Haemorrhage Guideline of the German-Speaking Countries.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023
    Review
  10. Article
  11. Article
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

22 authors at 4 institutions in 2 countries.

Anne-Sophie Ducloy-BouthorsObstetric Anaesthesia and Intensive Care Unit, Jeanne de Flandre Women's Hospital, Lille University Medical Centre, Lille, France; Groupe de Recherche sur les formes Injectables et les Technologies Associées, ULR 7365, Université de Lille, Lille, France. Electronic address: anne-sophie.bouthors@chru-lille.fr.
Sixtine GilliotGroupe de Recherche sur les formes Injectables et les Technologies Associées, ULR 7365, Université de Lille, Lille, France.
Maeva KyhengDépartement de Biostatistiques, Lille University Medical Centre, Lille, France; METRICS: évaluation des technologies de santé et des pratiques médicales, ULR 2694, Université de Lille, Lille, France.
David FaraoniBaylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.
Alexandre TurbelinObstetric Anaesthesia and Intensive Care Unit, Jeanne de Flandre Women's Hospital, Lille University Medical Centre, Lille, France.
Hawa Keita-MeyerAnaesthesia and Intensive Care Unit, Louis Mourier Hospital, Assistance Publique-Hôpitaux de Paris, Colombes, France.
Agnès RigouzzoAnaesthesia and Intensive Care Unit, Trousseau Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Gabriela MoyanotidouAnaesthesia and Intensive Care Unit, Les Bluets Women's Hospital, Assistance Publique-Hôpitaux de Paris, Colombes, France.
Benjamin ConstantAnaesthesia and Intensive Care Unit, Seclin General Hospital, Seclin, France.
Francoise BroisinAnaesthesia and Intensive Care Unit, Croix Rousse Lyon Academic Hospital, Lyon, France.
Agnès L GouezAnaesthesia and Intensive Care Unit, Béclère Hospital, Assistance Publique-Hôpitaux de Paris, Clamart, France.
Rémi FavierHaemostasis Unit, Haematological Laboratory, Armand Trousseau Children's Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Edith PeynaudHaemostasis Unit, Haematological Laboratory, Louis Mourier Hospital, Assistance Publique-Hôpitaux de Paris, Colombes, France.
Louise GhesquiereObstetric Unit, Jeanne de Flandre Women's Hospital, Lille University Medical Centre, Lille, France.
Gilles LebuffeGroupe de Recherche sur les formes Injectables et les Technologies Associées, ULR 7365, Université de Lille, Lille, France; Anaesthesia and Intensive Care Unit, Lille University Medical Centre, Lille, France.
Alain DuhamelDépartement de Biostatistiques, Lille University Medical Centre, Lille, France; METRICS: évaluation des technologies de santé et des pratiques médicales, ULR 2694, Université de Lille, Lille, France.
Delphine AllorgeToxicology Unit, Biology and Pathology Centre, Lille University Medical Centre, Lille, France.
Sophie SusenHaemostasis Unit, Biology and Pathology Centre, Lille University Medical Centre, Lille, France.
Benjamin HennartToxicology Unit, Biology and Pathology Centre, Lille University Medical Centre, Lille, France.
Emmanuelle JeanpierreHaemostasis Unit, Biology and Pathology Centre, Lille University Medical Centre, Lille, France.
Pascal OdouGroupe de Recherche sur les formes Injectables et les Technologies Associées, ULR 7365, Université de Lille, Lille, France.
TRACES working group
Université de Lille · FRAssistance Publique – Hôpitaux de Paris · FRHôpital Jeanne de Flandre · FRBaylor College of Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal dose of tranexamic acid to inhibit hyperfibrinolysis in postpartum haemorrhage is unclear. Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Cesarean Delivery (TRACES) was a double-blind, placebo-controlled, randomised, multicentre dose-ranging study to determine the dose-effect relationship for two regimens of intravenous tranexamic acid vs placebo.

methodsWomen experiencing postpartum haemorrhage during Caesarean delivery were randomised to receive placebo (n=60), tranexamic acid 0.5 g (n=57), or tranexamic acid 1 g i.v. (n=58). Biomarkers of fibrinolytic activation were assayed at five time points, with inhibition of hyperfibrinolysis defined as reductions in the increase over baseline in D-dimer and plasmin-antiplasmin levels and in the plasmin peak time.

resultsIn the placebo group, hyperfibrinolysis was evidenced by a mean increase over baseline [95% confidence interval] of 93% [68-118] for D-dimer level at 120 min and 56% [25-87] for the plasmin-antiplasmin level at 30 min. A dose of tranexamic acid 1 g was associated with smaller increases over baseline (D-dimers: 38% [13-63] [P=0.003 vs placebo]; plasmin-antiplasmin: -2% [-32 to 28] [P=0.009 vs placebo]). A dose of tranexamic acid 0.5 g was less potent, with non-significant reductions (D-dimers: 58% [32-84] [P=0.06 vs placebo]; plasmin-antiplasmin: 13% [18-43] [P=0.051]). Although both tranexamic acid doses reduced the plasmin peak, reduction in plasmin peak time was significant only for the 1 g dose of tranexamic acid.

conclusionsFibrinolytic activation was significantly inhibited by a dose of intravenous tranexamic acid 1 g but not 0.5 g. Pharmacokinetic-pharmacodynamic modelling of these data might identify the best pharmacodynamic monitoring criteria and the optimal tranexamic acid dosing regimen for treatment of postpartum haemorrhage. CLINICAL

trial registrationNCT02797119.

Indexed as

Antifibrinolytic AgentsBlood Coagulation DisordersPostpartum HemorrhageTranexamic AcidBiomarkersCesarean SectionDouble-Blind MethodFemaleFibrinolysinHumansPregnancyAntifibrinolytic AgentsBiomarkersFibrinolysinTranexamic Acidantifibrinolytic drugD-dimerfibrinogenfibrinolysisplasminplasmin–antiplasmin complexpostpartum haemorrhagethrombintranexamic acid

Identifiers

PMID36243576
PMCPMC9748994
OpenAlexW4304892063

What OpenQuestion holds

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LicenceCC BY
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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.