title: Effects of tranexamic acid on platelet function and thrombin generation (ETAPlaT): WOMAN trial sub-study.
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.
authors.affiliation: Institute for Medical Information Sciences, Biometry and Epidemiology, Ludwig Maximilian University of Munich, Munich, Germany.|University Hospital of Obstetrics Gynecology "Koço Gliozheni", Tirana, Albania.
authors.forename: Kastriot
authors.initials: K
authors.lastname: Dallaku
authors.affiliation: Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Haleema
authors.identifier: 0000-0002-6511-109X
authors.initials: H
authors.lastname: Shakur
authors.affiliation: Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Roberts
authors.affiliation: Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Phil
authors.initials: P
authors.lastname: Edwards
authors.affiliation: Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Danielle
authors.initials: D
authors.lastname: Beaumont
authors.affiliation: Department of Obstetrics and Gynaecology, Ludwig Maximilian University of Munich, Munich, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Delius
authors.affiliation: German Heart Centre, Technical University of Munich, Munich, Germany.
authors.forename: Braun
authors.initials: B
authors.lastname: Siegmund
authors.affiliation: University Hospital of Obstetrics Gynecology "Koço Gliozheni", Tirana, Albania.
authors.forename: Orion
authors.initials: O
authors.lastname: Gliozheni
authors.affiliation: University Hospital of Obstetrics Gynecology "Koço Gliozheni", Tirana, Albania.
authors.forename: Ilir
authors.initials: I
authors.lastname: Tasha
authors.affiliation: University Hospital of Obstetrics Gynecology "Koço Gliozheni", Tirana, Albania.
authors.forename: Saimir
authors.initials: S
authors.lastname: Cenameri
authors.affiliation: Institute for Medical Information Sciences, Biometry and Epidemiology, Ludwig Maximilian University of Munich, Munich, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mansmann
keywords: Coagulation Factors; Platelet function; Postpartum Hemorrhage; Tranexamic Acid