Statistical analysis plan for the WOMAN-ETAPlaT study: Effect of tranexamic acid on platelet function and thrombin generation

Kastriot Dallaku, Haleema Shakur, Phil Edwards, Danielle Beaumont, Ian Roberts, Sumaya Huque, Maria Delius, Ulrich Mansmann, Kastriot Dallaku, Haleema Shakur, Phil Edwards, Danielle Beaumont, Ian Roberts, Sumaya Huque, Maria Delius, Ulrich Mansmann

Abstract

Background. 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. Methods. 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. Results. 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. Conclusion. 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. Trial registration: ClinicalTrials.gov Identifier: NCT00872469; ISRCTN76912190.

Keywords: Antifibrinolytic; Multiplate Analyser; Statistical Analysis Plan; Thrombin Generation Assay.

Conflict of interest statement

Competing interests: No competing interests were disclosed.

Figures

Figure 1.. ETAPlaT sub-study flowchart:* Patients for…
Figure 1.. ETAPlaT sub-study flowchart:* Patients for whom there is no information on the primary endpoint.
Figure 2.. Effect of TXA on TGA…
Figure 2.. Effect of TXA on TGA parameters, regarding the platelet count before randomization (graph model using arbitrary data).
Figure 3.. Effect of TXA on coagulation…
Figure 3.. Effect of TXA on coagulation factors and platelet function, regarding the baseline fibrinogen level (graph model using arbitrary data).

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