Dallaku Kastriot, Shakur Haleema, Roberts Ian, Edwards Phil, Beaumont Danielle, Delius Maria, Siegmund Braun, Gliozheni Orion, Tasha Ilir, Cenameri Saimir, Mansmann Ulrich
Institute for Medical Information Sciences, Biometry and Epidemiology, Ludwig Maximilian University of Munich, Munich, Germany.
University Hospital of Obstetrics Gynecology "Koço Gliozheni", Tirana, Albania.
Wellcome Open Res. 2016 Dec 15;1:29. doi: 10.12688/wellcomeopenres.9964.1.
. Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid (TXA) has the potential to reduce bleeding and a large randomized placebo controlled trial of its effect in women with PPH (The WOMAN trial) is underway. TXA might also affect coagulation factors and platelets. . To examine the effect of TXA on thrombin generation, platelet function, fibrinogen, D-dimer and coagulation factors in women with PPH. . We will conduct a sub-study within the WOMAN trial. Women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion. Blood samples will be collected at baseline and 30 minutes after the first dose of study treatment. Using platelet poor plasma we will measure thrombin generation, fibrinogen, D-dimer, factor V and VIII, and Von Willebrand factor. Platelet function will be evaluated in whole blood using Multiplate® tests. . The primary outcome is the effect of TXA on thrombin generation. Secondary outcomes include the effect of TXA on platelet function, fibrinogen, D-dimer and coagulation factors.
产后出血（PPH）是孕产妇死亡的主要原因。氨甲环酸（TXA）有可能减少出血，一项关于其对PPH女性影响的大型随机安慰剂对照试验（WOMAN试验）正在进行中。TXA也可能影响凝血因子和血小板。
为了研究TXA对PPH女性凝血酶生成、血小板功能、纤维蛋白原、D-二聚体和凝血因子的影响。
我们将在WOMAN试验中进行一项子研究。经临床诊断为阴道或剖宫产术后原发性PPH的女性符合纳入条件。将在基线和首次给予研究治疗后30分钟采集血样。使用乏血小板血浆，我们将测量凝血酶生成、纤维蛋白原、D-二聚体、因子V和VIII以及血管性血友病因子。将使用Multiplate®检测法在全血中评估血小板功能。
主要结局是TXA对凝血酶生成的影响。次要结局包括TXA对血小板功能、纤维蛋白原、D-二聚体和凝血因子的影响。
