Haemostasis and Tranexamic Acid in Caesarean Delivery

NCT ID: NCT03742947

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2020-01-17

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).

Conditions

Postpartum Hemorrhage; Hyperfibrinolysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic acid

intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)

Group Type: EXPERIMENTAL

peripartum haemostasis

Intervention Type: DIAGNOSTIC_TEST

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.

Chloride solution

sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL)

Group Type: PLACEBO_COMPARATOR

peripartum haemostasis

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bordeaux Association for Training and Research in Obstetric Gynecology

UNKNOWN

Sponsor Role: collaborator

Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2018/24

Identifier Type: -

Identifier Source: org_study_id