An interventional study of peripartum haemostasis in Postpartum Hemorrhage and Hyperfibrinolysis, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
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).
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).
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 34 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patient randomized into TRAAP2 study (NCT03431805):
Exclusion Criteria:
patient not included into TRAAP2 study:
intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)
Diagnostic Test: peripartum haemostasis
sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL)
Diagnostic Test: peripartum haemostasis
Three blood samples of 20 ml each at T0 after the anaesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of the product.
Clot lysis time
Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
Time frame: Baseline (defined as the time of insertion of the peripheric venous line)
Lysis Timer clot lysis time
Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
Time frame: Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively)
Routine clot lysis time
Clot lysis time in minutes studied by the routine biological tests
Time frame: Baseline, Time 15min, and Time 120min
t-PA
tissue-Plasminogen Activator (ng/ml)
Time frame: Baseline, Time 15min, and Time 120min
PAI-1
Plasminogen activator inhibitor-1 (ng/ml)
Time frame: Baseline, Time 15min, and Time 120min
PAI-2
Plasminogen activator inhibitor-2 (ng/ml)
Time frame: Baseline, Time 15min, and Time 120min
Euglobulin clot lysis time
Euglobulin clot lysis time (min),
Time frame: Baseline, Time 15min, and Time 120min
Plasminogen
Plasminogen (%)
Time frame: Baseline, Time 15min, and Time 120min
Hb
Hemoglobin (g/dl)
Time frame: Baseline, Time 15min, and Time 120min
Platelets
Platelets (G/l)
Time frame: Baseline, Time 15min, and Time 120min
TP
Prothrombin ratio (%)
Time frame: Baseline, Time 15min, and Time 120min
aPTT ratio
Activated Cephalin Time (sec)
Time frame: Baseline, Time 15min, and Time 120min
Fibrinogen
Fibrinogen (g/l)
Time frame: Baseline, Time 15min, and Time 120min
Fibrin degradation products
Fibrin degradation products (µg/l)
Time frame: Baseline, Time 15min, and Time 120min
Plasmin-antiplasmin complex
Plasmin-antiplasmin complex (µg/l)
Time frame: Baseline, Time 15min, and Time 120min
Thrombin-antithrombin complex
Thrombin-antithrombin complex (ng/ml)
Time frame: Baseline, Time 15min, and Time 120min
Bleeding
Bleeding (ml)
Time frame: Baseline, Time 15min, and Time 120min
Transfusion of packs of red blood cells
Number of packs of red blood cells
Time frame: Time 120min
Transfusion of platelet concentrates
Number of platelet concentrates
Time frame: Time 120min
Transfusion of plasma
volume of plasma (ml)
Time frame: Time 120min
Transfusion of fibrinogen concentrate
Amount (g) of fibrinogen concentrate
Time frame: Time 120min
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux