Haemostasis and Tranexamic Acid in Caesarean Delivery
- Conditions
- Postpartum HemorrhageHyperfibrinolysis
- Interventions
- Diagnostic Test: peripartum haemostasis
- Registration Number
- NCT03742947
- Lead Sponsor
- University Hospital, Bordeaux
- Brief 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).
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
-
patient randomized into TRAAP2 study (NCT03431805):
- adult women admitted for a planned caesarean delivery,
- at term ≥ 34 weeks,
- haemoglobin level at the last blood sample >9g/dl,
- blood Formula numbering within 7 days before caesarean delivery, informed signed consent)
-
informed signed consent for BIO-TRAAP
-
patient not included into TRAAP2 study:
- previous thrombotic event or pre-existing pro-thrombotic disease,
- epileptic state or history of seizures,
- presence of any chronic or active cardiovascular disease outside hypertension,
- any chronic or active renal disease including renal, chronic or acute insufficiency (glomerular flow <90mL / min), and chronic or active liver disease at risk thrombotic or haemorrhagic,
- autoimmune disease,
- sickle cell disease,
- placenta praevia,
- placenta accreta/increta/percreta,
- abruption placentae,
- eclampsia,
- HELLP syndrome,
- in utero fetal death,
- administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
- general anaesthesia,
- hypersensitivity to tranexamic acid or concentrated hydrochloric acid, instrumental extraction failure,
- multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester,
- poor understanding of the French language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chloride solution peripartum haemostasis sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL) Tranexamic acid peripartum haemostasis intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)
- Primary Outcome Measures
Name Time Method Clot lysis time Baseline (defined as the time of insertion of the peripheric venous line) Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
- Secondary Outcome Measures
Name Time Method Fibrinogen Baseline, Time 15min, and Time 120min Fibrinogen (g/l)
Bleeding Baseline, Time 15min, and Time 120min Bleeding (ml)
t-PA Baseline, Time 15min, and Time 120min tissue-Plasminogen Activator (ng/ml)
Euglobulin clot lysis time Baseline, Time 15min, and Time 120min Euglobulin clot lysis time (min),
PAI-1 Baseline, Time 15min, and Time 120min Plasminogen activator inhibitor-1 (ng/ml)
Plasminogen Baseline, Time 15min, and Time 120min Plasminogen (%)
TP Baseline, Time 15min, and Time 120min Prothrombin ratio (%)
Fibrin degradation products Baseline, Time 15min, and Time 120min Fibrin degradation products (µg/l)
Transfusion of platelet concentrates Time 120min Number of platelet concentrates
Routine clot lysis time Baseline, Time 15min, and Time 120min Clot lysis time in minutes studied by the routine biological tests
aPTT ratio Baseline, Time 15min, and Time 120min Activated Cephalin Time (sec)
Transfusion of packs of red blood cells Time 120min Number of packs of red blood cells
PAI-2 Baseline, Time 15min, and Time 120min Plasminogen activator inhibitor-2 (ng/ml)
Hb Baseline, Time 15min, and Time 120min Hemoglobin (g/dl)
Platelets Baseline, Time 15min, and Time 120min Platelets (G/l)
Plasmin-antiplasmin complex Baseline, Time 15min, and Time 120min Plasmin-antiplasmin complex (µg/l)
Thrombin-antithrombin complex Baseline, Time 15min, and Time 120min Thrombin-antithrombin complex (ng/ml)
Transfusion of plasma Time 120min volume of plasma (ml)
Lysis Timer clot lysis time Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively) Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer
Transfusion of fibrinogen concentrate Time 120min Amount (g) of fibrinogen concentrate
Trial Locations
- Locations (1)
CHU Bordeaux
🇫🇷Bordeaux, France