1. Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial
- Author
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Cecilia O. Adetayo, Chris Aimakhu, Ian Roberts, Ulrich Mansmann, Eni Balogun, Adenike Bello, Modupe Kuti, Kastriot Dallaku, Sumaya Huque, Tolulase Olutogun, Bukola Fawole, Olayinka Ogunbode, Kotila Tr, Tracey Pepple, Haleema Shakur-Still, Beverley J. Hunt, Olujide Okunade, and Oladapo Olayemi
- Subjects
0301 basic medicine ,medicine.medical_treatment ,Placebo-controlled study ,Medicine (miscellaneous) ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Thromboelastogram ,law ,Fibrinolysis ,medicine ,Coagulation testing ,030212 general & internal medicine ,Coagulation ,business.industry ,Articles ,medicine.disease ,3. Good health ,Thromboelastometry ,030104 developmental biology ,Tranexamic Acid ,Anesthesia ,Maternal death ,Postpartum Haemorrhage ,business ,Tranexamic acid ,Randomised Controlled Trial ,medicine.drug ,Research Article - 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) andNCT00872469(initially registered 31/03/2009, WOMAN-ETAC included on 22/03/2012).
- Published
- 2018