1. Effects of tranexamic acid on platelet function and thrombin generation (ETAPlaT): WOMAN trial sub-study
- Author
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Phil Edwards, Maria Delius, Saimir Cenameri, Orion Gliozheni, Haleema Shakur, Ilir Tasha, Danielle Beaumont, Ulrich Mansmann, Braun Siegmund, Ian Roberts, and Kastriot Dallaku
- Subjects
medicine.medical_specialty ,genetic structures ,Medicine (miscellaneous) ,Fibrinogen ,01 natural sciences ,Gastroenterology ,General Biochemistry, Genetics and Molecular Biology ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Von Willebrand factor ,Internal medicine ,medicine ,Platelet ,0101 mathematics ,Platelet-poor plasma ,biology ,business.industry ,Postpartum Hemorrhage ,010102 general mathematics ,Factor V ,Pregnancy, Labor, Delivery & Postpartum Care ,030208 emergency & critical care medicine ,Articles ,medicine.disease ,3. Good health ,Tranexamic Acid ,Coagulation ,biology.protein ,Platelet function ,Maternal death ,business ,Coagulation Factors ,Tranexamic acid ,medicine.drug - Abstract
Background. 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. Objectives. To examine the effect of TXA on thrombin generation, platelet function, fibrinogen, D-dimer and coagulation factors in women with PPH. Methods. 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.Outcomes. 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.
- Published
- 2016
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