Abstract. Postpartum haemorrhage (PPH) is a potentially life-threatening Background 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.. WOMAN ETAPlaT is a sub-study of the World Maternal Methods 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.Recruitment to WOMAN ETAPlaT started on 04 November 2013 and Results. 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.The data from this study will provide evidence for the effect of Conclusion. TXA on thrombin generation, platelet function and coagulation factors in women with PPH.
Amendments from Version 1The differences of the second version of "Statistical analysis plan for the WOMAN-ETAPlaT study: Effect of tranexamic acid on platelet function and thrombin generation" has been based on the comments from referees:1. Removed the exploratory subgroup analysis section, because the total sample size was small and the subgroup analyses run the risk of false positive. Also, it was removed a section with evidence about effect of TXA on thrombin generation, because some evidence it was provided at the protocol paper of ETAPlaT sub-study.2. We added a flowchart according to CONSORT to report the participant progress in the ETAPlaT sub-study (Figure 1), allocation of patients in TXA or placebo group, lost of follow up and exclusion from analysis. Two sections were added, one section for safety report for all patients randomized in the substudy, about adverse events and serious adverse events. Another section added was about adherence, to report measures of compliance by trial arm.
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REVISED
PrefaceThe purpose of the statistical analysis plan (SAP) is to ensure the credibility of the study findings by pre-specifying the statistical approaches to the analysis of the study data prior to hard locking the database and unblinding of the WOMAN ETAPlaT trial data. To prevent outcome bias and selective reporting, a detailed SAP is presented in order to avoid post hoc decisions that may influence the interpretation of the results and the statistical analyses of the final data.This SAP is a technical extension of the WOMAN ...