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

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 wom...

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Published: 2018
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LEADER 00000njm a2000000a 4500
001 oai:repository.ui.edu.ng:123456789/11843
042 |a dc 
720 |a Shakur-Still, H.  |e author 
720 |a Roberts, I.  |e author 
720 |a Fawole, B.  |e author 
720 |a Kuti, M.  |e author 
720 |a Olayemi, O. O.  |e author 
720 |a Bello, A.  |e author 
720 |a Huque, S.  |e author 
720 |a Ogunbode, O.  |e author 
720 |a Kotila, T.|  |e author 
720 |a Aimakhu, C.  |e author 
720 |a Okunade, O. A.  |e author 
720 |a Olutogun, T.  |e author 
720 |a Adetayo, C. O.  |e author 
720 |a Dallaku, K.  |e author 
720 |a Mansmann, U.  |e author 
720 |a Hunt, B. J.  |e author 
720 |a Pepple, T.  |e author 
720 |a Balogun, E.  |e author 
260 |c 2018 
520 |a 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. 
024 8 |a 2398-502X 
024 8 |a ui_art_shakur_effect_2018 
024 8 |a Wellcome Open Research 3(100), pp. 1-12 
024 8 |a https://repository.ui.edu.ng/handle/123456789/11843 
653 |a Postpartum Haemorrhage 
653 |a Fibrinolysis 
653 |a Coagulation 
653 |a Tranexamic Acid 
653 |a Randomised Controlled Trail 
653 |a Thromboelastogram 
245 0 0 |a Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial