Shakur-Still Haleema, Roberts Ian, Fawole Bukola, Kuti Modupe, Olayemi Oladapo O, Bello Adenike, Huque Sumaya, Ogunbode Olayinka, Kotila Taiwo, Aimakhu Chris, Okunade Olujide A, Olutogun Tolulase, Adetayo Cecilia O, Dallaku Kastriot, Mansmann Ulrich, Hunt Beverley J, Pepple Tracey, Balogun Eni
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.
Wellcome Open Res. 2018 Aug 15;3:100. doi: 10.12688/wellcomeopenres.14722.1. eCollection 2018.
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. 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. 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. TXA treatment was associated with reduced D-dimer levels but had no apparent effects on thromboelastometry parameters or coagulation tests. 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).
产后出血（PPH）是孕产妇死亡的主要原因。WOMAN试验表明，氨甲环酸（TXA）可降低PPH女性因出血导致的死亡。我们评估了TXA对WOMAN试验参与者样本中纤维蛋白溶解和凝血的影响。在WOMAN试验中，临床诊断为PPH的成年女性被随机分配接受1 g TXA或匹配的安慰剂。尼日利亚伊巴丹大学学院医院参与WOMAN试验的参与者在首次给予试验治疗前也采集了静脉血，并在首次给药后30（±15）分钟再次采集（ETAC研究）。我们旨在确定TXA对纤维蛋白溶解（D - 二聚体和旋转血栓弹力图最大凝块溶解（ML））和凝血（国际标准化比值和5分钟时的凝块幅度）的影响。我们使用线性回归比较接受TXA和安慰剂的女性的结果，并对基线测量进行调整。女性（n = 167）被随机分配接受TXA（n = 83）或匹配的安慰剂（n = 84）。由于数据缺失，7名女性被排除在分析之外。接受TXA治疗的女性的平均（SD）D - 二聚体浓度为7.1（7.0）mg/l，接受安慰剂治疗的女性为9.6（8.6）mg/l（p = 0.09）。在对基线进行调整后，接受TXA治疗的女性的D - 二聚体浓度低2.16 mg/l（-2.16，95% CI -4.31至0.00，p = 0.05）。接受TXA和安慰剂治疗的女性在ML方面无显著差异（分别为12.3%（18.4）和10.7%（
