Dallaku Kastriot, Shakur Haleema, Edwards Phil, Beaumont Danielle, Roberts Ian, Huque Sumaya, Delius Maria, Mansmann Ulrich
Institute for Medical Information Sciences, Biometry and Epidemiology, Klinikum Großhadern, Ludwig-Maximilian University, Munich, Germany.
University Hospital of Obstetrics Gynaecology "Koco Gliozheni, Tirana, Albania.
Wellcome Open Res. 2016 Dec 15;1:30. doi: 10.12688/wellcomeopenres.10105.2.
. Postpartum haemorrhage (PPH) is a potentially life-threatening complication for women, and the leading cause of maternal mortality. Tranexamic acid (TXA) is an antifibrinolytic used worldwide to treat uterine haemorrhage and to reduce blood loss in general surgery. TXA may have effects on thrombin generation, platelet function and coagulation factors as a result of its inhibition on the plasmin. . WOMAN ETAPlaT is a sub-study of the World Maternal Antifibrinolitic trial (WOMAN trial). All adult women clinically diagnosed with PPH after a vaginal delivery or caesarean section, are eligible for inclusion in the study. Blood samples will be collected at the baseline and 30 minutes after the first dose of study treatment is given. Platelet function will be evaluated in whole blood immediately after sampling with Multiplate® tests (ADPtest and TRAPtest). Thrombin generation, fibrinogen, D-dimer, and coagulation factors vW, V and VIII will be analysed using platelet poor plasma. Recruitment to WOMAN ETAPlaT started on 04 November 2013 and closed on 13 January 2015, during this time 188 patients were recruited. The final participant follow-up was completed on 04 March 2015. This article introduces the statistical analysis plan for the study, without reference to unblinded data. The data from this study will provide evidence for the effect of TXA on thrombin generation, platelet function and coagulation factors in women with PPH. : ClinicalTrials.gov Identifier: NCT00872469; ISRCTN76912190.
产后出血（PPH）对女性来说是一种潜在的危及生命的并发症，也是孕产妇死亡的主要原因。氨甲环酸（TXA）是一种抗纤溶药物，在全球范围内用于治疗子宫出血以及减少普通外科手术中的失血。由于其对纤溶酶的抑制作用，TXA可能会对凝血酶生成、血小板功能和凝血因子产生影响。WOMAN ETAPlaT是世界孕产妇抗纤溶试验（WOMAN试验）的一项子研究。所有经临床诊断为阴道分娩或剖宫产术后发生PPH的成年女性均符合纳入本研究的条件。将在基线时以及给予首剂研究治疗后30分钟采集血样。采样后立即用Multiplate®检测（ADP检测和TRAP检测）对全血中的血小板功能进行评估。将使用乏血小板血浆分析凝血酶生成、纤维蛋白原、D-二聚体以及凝血因子vW、V和VIII。WOMAN ETAPlaT的招募工作于2013年11月4日开始，2015年1月13日结束，在此期间招募了188名患者。最终的参与者随访于2015年3月4日完成。本文介绍了该研究的统计分析计划，未提及未盲法数据。本研究的数据将为TXA对PPH女性的凝血酶生成、血小板功能和凝血因子的影响提供证据。：ClinicalTrials.gov标识符：NCT00872469；ISRCTN76912190。
