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Open Access Highly Accessed Research

High-dose tranexamic acid reduces blood loss in postpartum haemorrhage

Anne-Sophie Ducloy-Bouthors1*, Brigitte Jude23, Alain Duhamel45, Françoise Broisin6, Cyril Huissoud7, Hawa Keita-Meyer89, Laurent Mandelbrot109, Nadia Tillouche11, Sylvie Fontaine11, Françoise Le Goueff12, Sandrine Depret-Mosser13, Benoit Vallet114, The EXADELI Study Group15 and Sophie Susen23

Author Affiliations

1 Pole d'Anesthésie-Réanimation, CHU Lille, 2 avenue Oscar Lambret, Lille F-59037, France

2 Pole d'Hématologie Transfusion, CHU Lille, 2 avenue Oscar Lambret, Lille F-59037, France

3 EA2693, Université Lille Nord de France, 1 place de Verdun, Lille F-59045, France

4 Pole de Santé Publique, CHU Lille, 2 avenue Oscar Lambret, Lille F-59037, France

5 EA2694, Université Lille Nord de France, 1 place de Verdun, Lille F-59045, France

6 Pole d'Anesthésie-Réanimation, Hôpital de la Croix Rousse, Hôpitaux civils de Lyon, 93 grande rue de la Croix-Rousse, Lyon F-69000, France

7 Pole d'obstétrique, Hôpital de la Croix Rousse, Hôpitaux civils de Lyon, 93 grande rue de la Croix-Rousse, Lyon F-69004, France

8 Service d'Anesthésie-Réanimation, CHU Louis Mourier, Assistance Publique des Hôpitaux de Paris, 178 rue des Renouillers, Colombes F-92701, France

9 Université Paris 7 - Diderot, 5 rue Thomas Mann, Paris F-75013, France

10 Service d'obstétrique, CHU Louis Mourier, Assistance Publique des Hôpitaux de Paris, 178 rue des Renouillers, Colombes F-92701, France

11 Service d'Anesthésie-Réanimation, Maternité Monaco, rue Desandrouins, centre hospitalier, Valenciennes F-59300, France

12 Service d'Anesthésie-Réanimation, Maternité Paul Gellée, 91 avenue Julien Lagache, centre hospitalier, Roubaix F-59100, France

13 Pole d'Obstétrique, CHU Lille, 2 avenue Oscar Lambret, Lille F-59037, France

14 EA2689, Université Lille Nord de France, 1 place de Verdun, Lille F-59045, France

15 Pole recherche, CHU Lille, 2 avenue Oscar Lambret, Lille F-59037, France

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Critical Care 2011, 15:R117  doi:10.1186/cc10143

Published: 15 April 2011

Abstract

Introduction

Our purpose in conducting this study was to determine whether administration of high-dose tranexamic acid (TA) at the time of diagnosis of postpartum haemorrhage (PPH) could reduce blood loss.

Methods

This was a randomised, controlled, multicentred, open-label trial. Women with PPH >800 mL following vaginal delivery were randomly assigned to receive TA (loading dose 4 g over 1 hour, then infusion of 1 g/hour over 6 hours) or not. In both groups, packed red blood cells (PRBCs) and colloids could be used according to French guidelines. The use of additional procoagulant treatments was permitted only in cases involving intractable bleeding. The primary objective was to assess the efficacy of TA in the reduction of blood loss in women with PPH, and the secondary objectives were the effect of TA on PPH duration, anaemia, transfusion and the need for invasive procedures.

Results

A total of 144 women fully completed the protocol (72 in each group). Blood loss between enrolment and 6 hours later was significantly lower in the TA group than in the control group (median, 173 mL; first to third quartiles, 59 to 377) than in controls (221 mL; first to third quartiles 105 to 564) (P = 0.041). In the TA group, bleeding duration was shorter and progression to severe PPH and PRBC transfusion was less frequent than in controls (P < 0.03). Invasive procedures were performed in four women in the TA group and in seven controls (P = NS). PPH stopped after only uterotonics and PRBC transfusion in 93% of women in the TA group versus 79% of controls (P = 0.016). Mild, transient adverse manifestations occurred more often in the TA group than in the control group (P = 0.03).

Conclusions

This study is the first to demonstrate that high-dose TA can reduce blood loss and maternal morbidity in women with PPH. Although the study was not adequately powered to address safety issues, the observed side effects were mild and transient. A larger international study is needed to investigate whether TA can decrease the need for invasive procedures and reduce maternal morbidity in women with PPH.

Trial registration

Controlled Trials ISRCTN09968140.