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Haemostasis and Tranexamic Acid in Caesarean Delivery (BIO-TRAAP)

Primary Purpose

Postpartum Hemorrhage, Hyperfibrinolysis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

peripartum haemostasis

About this trial

This is an interventional diagnostic trial for Postpartum Hemorrhage focused on measuring ancillary biologic study, fibrinolysis, tranexamic acid, post-partum haemorrhage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

CHU Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid

Chloride solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clot lysis time

Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer

Secondary Outcome Measures

Lysis Timer clot lysis time

Clot lysis time in minutes studied by the Global Fibrinolytic Capacity on the Lysis Timer

Routine clot lysis time

Clot lysis time in minutes studied by the routine biological tests

t-PA

tissue-Plasminogen Activator (ng/ml)

PAI-1

Plasminogen activator inhibitor-1 (ng/ml)

PAI-2

Plasminogen activator inhibitor-2 (ng/ml)

Euglobulin clot lysis time

Euglobulin clot lysis time (min),

Plasminogen

Plasminogen (%)

Hemoglobin (g/dl)

Platelets

Platelets (G/l)

Prothrombin ratio (%)

aPTT ratio

Activated Cephalin Time (sec)

Fibrinogen

Fibrinogen (g/l)

Fibrin degradation products

Fibrin degradation products (µg/l)

Plasmin-antiplasmin complex

Plasmin-antiplasmin complex (µg/l)

Thrombin-antithrombin complex

Thrombin-antithrombin complex (ng/ml)

Bleeding

Bleeding (ml)

Transfusion of packs of red blood cells

Number of packs of red blood cells

Transfusion of platelet concentrates

Number of platelet concentrates

Transfusion of plasma

volume of plasma (ml)

Transfusion of fibrinogen concentrate

Amount (g) of fibrinogen concentrate

Full Information

NCT ID

NCT03742947

First Posted

October 30, 2018

Last Updated

April 28, 2020

Sponsor

University Hospital, Bordeaux

Collaborators

Bordeaux Association for Training and Research in Obstetric Gynecology, Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation

1. Study Identification

Unique Protocol Identification Number

NCT03742947

Brief Title

Haemostasis and Tranexamic Acid in Caesarean Delivery

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 10, 2019 (Actual)

Primary Completion Date

January 17, 2020 (Actual)

Study Completion Date

January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

Collaborators

Bordeaux Association for Training and Research in Obstetric Gynecology, Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hemorrhage, Hyperfibrinolysis

Keywords

ancillary biologic study, fibrinolysis, tranexamic acid, post-partum haemorrhage

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Three blood samples of 20 ml each at T0 after the anesthesia 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 TRAAP2 study IMP (tranexamic acid or placebo).

Masking

ParticipantInvestigator

Masking Description

Double blind

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic acid

Arm Type

Experimental

Arm Description

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

Arm Title

Chloride solution

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

peripartum haemostasis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Clot lysis time

Description

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)

Secondary Outcome Measure Information:

Title

Lysis Timer clot lysis time

Description

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)

Title

Routine clot lysis time

Description

Clot lysis time in minutes studied by the routine biological tests

Time Frame