Back to Search Results

Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial

Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Department of Obstetrics & Gynaecology National Institute of Maternal and Child Health, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Chemical Pathology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Obstetrics & Gynaecology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Obstetrics & Gynaecology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Department of Obstetrics & Gynaecology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Haematology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Obstetrics & Gynaecology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Obstetrics & Gynaecology National Institute of Maternal and Child Health, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Haematology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Department of Obstetrics & Gynaecology National Institute of Maternal and Child Health, College of Medicine, University of Ibadan, Ibadan, Nigeria. Institute for Medical Information Sciences, Biometry and Epidemiology, Ludwig Maximilian University of Munich, Munich, Germany. University Hospital of Obstetrics Gynaecology "Koco Gliozheni", Tirana, Albania. University Hospital of Obstetrics Gynaecology "Koco Gliozheni", Tirana, Albania. Thrombosis & Haemophilia Centre, Guy's & St Thomas' Trust, London, UK. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.

Wellcome Open Research. 2018;3:100.
Full text from:

Other resources

Abstract
Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. The WOMAN trial showed that tranexamic acid (TXA) reduces death due to bleeding in women with PPH. We evaluated the effect of TXA on fibrinolysis and coagulation in a sample of WOMAN trial participants. Methods: Adult women with a clinical diagnosis of PPH were randomised to receive 1 g TXA or matching placebo in the WOMAN trial. Participants in the WOMAN trial at University College Hospital (Ibadan, Nigeria) also had venous blood taken just before administration of the first dose of trial treatment and again 30 (+/-15) min after the first dose (the ETAC study). We aimed to determine the effects of TXA on fibrinolysis (D-dimer and rotational thromboelastometry maximum clot lysis (ML)) and coagulation (international normalized ratio and clot amplitude at 5 min). We compared outcomes in women receiving TXA and placebo using linear regression, adjusting for baseline measurements. Results: Women (n=167) were randomised to receive TXA (n=83) or matching placebo (n=84). Due to missing data, seven women were excluded from analysis. The mean (SD) D-dimer concentration was 7.1 (7.0) mg/l in TXA-treated women and 9.6 (8.6) mg/l in placebo-treated women (p=0.09). After adjusting for baseline, the D-dimer concentration was 2.16 mg/l lower in TXA-treated women (-2.16, 95% CI -4.31 to 0.00, p=0.05). There was no significant difference in ML between TXA- and placebo-treated women (12.3% (18.4) and 10.7% (12.6), respectively; p=0.52) and no significant difference after adjusting for baseline ML (1.02, 95% CI -3.72 to 5.77, p=0.67). There were no significant effects of TXA on any other parameters. Conclusion: TXA treatment was associated with reduced D-dimer levels but had no apparent effects on thromboelastometry parameters or coagulation tests. Registration: ISRCTN76912190 (initially registered 10/12/2008, WOMAN-ETAC included on 22/03/2012) and NCT00872469 (initially registered 31/03/2009, WOMAN-ETAC included on 22/03/2012).
Study details
Language : English
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine