Open Peer Review Discuss this article (0) Comments RESEARCH ARTICLE Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial [version 1; referees: 2 approved] Haleema Shakur-Still , Ian Roberts , Bukola Fawole , Modupe Kuti , Oladapo O. Olayemi , Adenike Bello , Sumaya Huque , Olayinka Ogunbode , Taiwo Kotila , Chris Aimakhu , Olujide A. Okunade , Tolulase Olutogun , Cecilia O. Adetayo , Kastriot Dallaku , Ulrich Mansmann , Beverley J. Hunt , Tracey Pepple , Eni Balogun 1 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 Haematology, 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 “Koço Gliozheni”, Tirana, Albania Thrombosis & Haemophilia Centre, Guy’s & St Thomas’ Trust, London, UK Abstract Postpartum haemorrhage (PPH) is a leading cause of maternal Background: 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. Adult women with a clinical diagnosis of PPH were randomised to Methods: 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. Women (n=167) were randomised to receive TXA (n=83) or matching Results: 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 1 1 2 3 4 4 1 4 5 4 2 5 2 6,7 7 8 1 1 1 2 3 4 5 6 7 8 Referee Status: Invited Referees version 1 published 15 Aug 2018 1 2 report report , George Washington Homa K. Ahmadzia University , USA 1 , University Stanislas Grassin-Delyle of Paris-Saclay, France 2 15 Aug 2018, :100 (doi: ) First published: 3 10.12688/wellcomeopenres.14722.1 15 Aug 2018, :100 (doi: ) Latest published: 3 10.12688/wellcomeopenres.14722.1 v1 Page 1 of 12 Wellcome Open Research 2018, 3:100 Last updated: 02 OCT 2018