Tranexamic acid dose-response relationship for antifibrinolysis in postpartum haemorrhage during Caesarean delivery: TRACES, a double-blind, placebo-controlled, multicentre, dose-ranging biomarker study. - Université de Lille
Article Dans Une Revue Br J Anaesth Année : 2022

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

Gabriela Moyanotidou
  • Fonction : Auteur
Benjamin Constant
  • Fonction : Auteur
Françoise Broisin
  • Fonction : Auteur
Agnès L. Gouez
  • Fonction : Auteur
Rémi Favier
  • Fonction : Auteur
Edith Peynaud
  • Fonction : Auteur
Cyril Huissoud
  • Fonction : Auteur
  • PersonId : 888415
Charles Garabedian
Frédéric J. Mercier
Catherine Barre-Drouard
  • Fonction : Auteur
Max Gonzalez Estevez
  • Fonction : Auteur
Julien Corouge
  • Fonction : Auteur
Anne-Sophie Baptiste
  • Fonction : Auteur
  • PersonId : 1327969
Anne-Frédérique Dalmas
  • Fonction : Auteur

Résumé

Background The 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. Methods Women 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. Results In 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. Conclusions Fibrinolytic 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.
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hal-04144301 , version 1 (28-06-2023)

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Anne-Sophie Ducloy-Bouthors, Sixtine Gilliot, Maeva Kyheng, David Faraoni, Alexandre Turbelin, et al.. Tranexamic acid dose-response relationship for antifibrinolysis in postpartum haemorrhage during Caesarean delivery: TRACES, a double-blind, placebo-controlled, multicentre, dose-ranging biomarker study.. Br J Anaesth, 2022, Br J Anaesth, 129 (6), pp.937-945. ⟨10.1016/j.bja.2022.08.033⟩. ⟨hal-04144301⟩
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