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Haemostasis and Tranexamic Acid in Caesarean Delivery — BIO-TRAAP  

Postpartum Hemorrhage Clinical Trial

Official title:
Study of Peripartum Haemostasis and Effects of Tranexamic Acid in Caesarean Delivery: Biologic Ancillary Study in TRAAP2 Patients Recruited at the Bordeaux University Hospital: BIO-TRAAP

Clinical Trial Summary

The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH).

Clinical Trial Description

Post-partum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality. Haemostasis and fibrinolysis are activated in peripartum. Fibrinolysis is decreased during pregnancy, is quickly activated after childbirth and can be overactivated in case of PPH. Tranexamic acid (TXA), an antifibrinolytic drug, has been proven to efficiently decrease bleeding and death in PPH. Its place in prevention of PPH after caesarean section remains to be established. The aim of the study protocol TRAAP2 is to conduct a large multicentre randomized, double blind placebo-controlled trial to adequately assess the impact of TXA for preventing PPH following a caesarean section. Peripartum is also a period of increased thrombo-embolic risk. TXA has never been proven to increase thromboembolic events. Nevertheless, it seems important to reserve TXA for women with activated fibrinolysis.

The aim of the ancillary biologic study BIO-TRAAP is thus to explore haemostasis and fibrinolysis in peripartum, to determine which women will in the future benefit from TXA. Fibrinolysis will be studied by clot lysis time by Global Fibrinolytic Capacity test on the Lysis Timer (GFC/LT), t-PA, PAI-1, PAI-2, euglobulin clot lysis time, plasminogen, plasmin-anti-plasmin complex, thrombin-anti-thrombin complex, fibrin degradation products (FDP). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03742947
Study type Interventional
Source University Hospital, Bordeaux
Contact
Status Completed
Phase N/A
Start date January 10, 2019
Completion date January 17, 2020
View Details
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