Dallaku, Kastriot; Shakur-Still, Haleema; Beaumont, Danielle; Roberts, Ian; Huque, Sumaya; Delius, Maria; Holdenrieder, Stefan; Gliozheni, Orion; Mansmann, Ulrich; (2019) No effect of tranexamic acid on platelet function and thrombin generation (ETAPlaT) in postpartum haemorrhage: a randomised placebo-controlled trial. Wellcome open research, 4. 21-. ISSN 2398-502X DOI: https://doi.org/10.12688/wellcomeopenres.14977.1
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Abstract
<b>Background:</b> Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity. The WOMAN trial showed that tranexamic acid (TXA) reduces death due to bleeding in women with PPH. To determine whether TXA has pro-thrombotic effects in women with PPH, we measured endogenous thrombin potential (ETP), coagulation factors V, VIII, von Willebrand (vW), fibrinogen, D-Dimers and platelet function. <b>Methods</b>: We conducted a sub-study within the WOMAN trial, an international randomized, parallel-group, double blind, placebo-controlled trial. Women with primary PPH were randomly allocated to receive 1 gram of tranexamic acid or matching placebo. Baseline blood samples were collected just prior to the first dose and a follow up sample was collected 30±15 minutes afterwards. We compared before and after changes in coagulation parameters between treatment groups using repeated measurement ANOVA. Change in ETP was the primary outcome. We did an intention-to-treat analysis using ANCOVA with adjustment for baseline and the time interval between the blood samples. <b>Findings:</b> A total of 187 patients were randomized to receive TXA (n=93) or matching placebo (n=94). Six patients were excluded due to incomplete data. The reduction in ETP from baseline to follow up was 43.2 nM*min (95%CI, -16.6 to 103.1) in the TXA group and 4.6 nM*min (95%CI, -51.4 to 60.6) in the placebo group. The difference was not statistically significant (95%CI, -42.9 to 120). There were no significant effects of TXA treatment on any other parameters (ADPtest, TRAPtest, coagulation factors activity, fibrinogen levels, D-Dimer level). <b>Conclusion:</b> We found no evidence that tranexamic acid treatment for PPH has substantial pro-coagulant effects. However, larger studies are needed to confirm or refute more modest effects. <b>Trial registration:</b> ISRCTN76912190 (initially registered 10/12/2008, WOMAN-ETAPlat included on 28/10/2013) and NCT00872469 (initially registered 31/03/2009, WOMAN-ETAPlat included on 28/10/2013).
Item Type | Article |
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Faculty and Department |
Faculty of Epidemiology and Population Health > Dept of Population Health (2012- ) Faculty of Epidemiology and Population Health > Dept of Medical Statistics |
Research Centre |
Centre for Maternal, Reproductive and Child Health (MARCH) Clinical Trials Unit |
PubMed ID | 31223662 |
Elements ID | 133743 |
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