Haemostasis and Tranexamic Acid in Caesarean Delivery

Postpartum Hemorrhage Clinical Trial

— BIO-TRAAP  

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 Details — Status: Completed

Administrative data

• NCT number: NCT03742947
• Other study ID #: CHUBX 2018/24
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hyperfibrinolysis
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation, Bordeaux Association for Training and Research in Obstetric Gynecology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clot lysis time	Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer	Baseline (defined as the time of insertion of the peripheric venous line)
Secondary	Lysis Timer clot lysis time	Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer	Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively)
Secondary	Routine clot lysis time	Clot lysis time in minutes studied by the routine biological tests	Baseline, Time 15min, and Time 120min
Secondary	t-PA	tissue-Plasminogen Activator (ng/ml)	Baseline, Time 15min, and Time 120min
Secondary	PAI-1	Plasminogen activator inhibitor-1 (ng/ml)	Baseline, Time 15min, and Time 120min
Secondary	PAI-2	Plasminogen activator inhibitor-2 (ng/ml)	Baseline, Time 15min, and Time 120min
Secondary	Euglobulin clot lysis time	Euglobulin clot lysis time (min),	Baseline, Time 15min, and Time 120min
Secondary	Plasminogen	Plasminogen (%)	Baseline, Time 15min, and Time 120min
Secondary	Hb	Hemoglobin (g/dl)	Baseline, Time 15min, and Time 120min
Secondary	Platelets	Platelets (G/l)	Baseline, Time 15min, and Time 120min
Secondary	TP	Prothrombin ratio (%)	Baseline, Time 15min, and Time 120min
Secondary	aPTT ratio	Activated Cephalin Time (sec)	Baseline, Time 15min, and Time 120min
Secondary	Fibrinogen	Fibrinogen (g/l)	Baseline, Time 15min, and Time 120min
Secondary	Fibrin degradation products	Fibrin degradation products (µg/l)	Baseline, Time 15min, and Time 120min
Secondary	Plasmin-antiplasmin complex	Plasmin-antiplasmin complex (µg/l)	Baseline, Time 15min, and Time 120min
Secondary	Thrombin-antithrombin complex	Thrombin-antithrombin complex (ng/ml)	Baseline, Time 15min, and Time 120min
Secondary	Bleeding	Bleeding (ml)	Baseline, Time 15min, and Time 120min
Secondary	Transfusion of packs of red blood cells	Number of packs of red blood cells	Time 120min
Secondary	Transfusion of platelet concentrates	Number of platelet concentrates	Time 120min
Secondary	Transfusion of plasma	volume of plasma (ml)	Time 120min
Secondary	Transfusion of fibrinogen concentrate	Amount (g) of fibrinogen concentrate	Time 120min