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

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

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).

Study Overview

• Status: Completed
• Conditions: Hyperfibrinolysis; Postpartum Hemorrhage
• Intervention / Treatment: Diagnostic test: peripartum haemostasis

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).

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)	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.
Placebo Comparator: Chloride solution; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Routine clot lysis time	Clot lysis time in minutes studied by the routine biological tests	Baseline, Time 15min, and Time 120min
t-PA	tissue-Plasminogen Activator (ng/ml)	Baseline, Time 15min, and Time 120min
PAI-1	Plasminogen activator inhibitor-1 (ng/ml)	Baseline, Time 15min, and Time 120min
PAI-2	Plasminogen activator inhibitor-2 (ng/ml)	Baseline, Time 15min, and Time 120min
Euglobulin clot lysis time	Euglobulin clot lysis time (min),	Baseline, Time 15min, and Time 120min
Plasminogen	Plasminogen (%)	Baseline, Time 15min, and Time 120min
Hb	Hemoglobin (g/dl)	Baseline, Time 15min, and Time 120min
Platelets	Platelets (G/l)	Baseline, Time 15min, and Time 120min
TP	Prothrombin ratio (%)	Baseline, Time 15min, and Time 120min
aPTT ratio	Activated Cephalin Time (sec)	Baseline, Time 15min, and Time 120min
Fibrinogen	Fibrinogen (g/l)	Baseline, Time 15min, and Time 120min
Fibrin degradation products	Fibrin degradation products (µg/l)	Baseline, Time 15min, and Time 120min
Plasmin-antiplasmin complex	Plasmin-antiplasmin complex (µg/l)	Baseline, Time 15min, and Time 120min
Thrombin-antithrombin complex	Thrombin-antithrombin complex (ng/ml)	Baseline, Time 15min, and Time 120min
Bleeding	Bleeding (ml)	Baseline, Time 15min, and Time 120min
Transfusion of packs of red blood cells	Number of packs of red blood cells	Time 120min
Transfusion of platelet concentrates	Number of platelet concentrates	Time 120min
Transfusion of plasma	volume of plasma (ml)	Time 120min
Transfusion of fibrinogen concentrate	Amount (g) of fibrinogen concentrate	Time 120min

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Bordeaux Association for Training and Research in Obstetric Gynecology; Association of Anesthesiologists and Intensivists of Vascular Surgery and Transplantation

Publications and helpful links

General Publications

• Roullet S, Rivoire T, Houssin C, Labrouche S, Paquin S, Nouette-Gaulain K, Deneux-Tharaux C, Amiral J, James C, Sentilhes L. Hemostatic Effects of Tranexamic Acid in Cesarean Delivery: An Ancillary Study of the TRAAP2 Study. Thromb Haemost. 2022 Nov;122(11):1869-1878. doi: 10.1055/s-0042-1755379. Epub 2022 Sep 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: tranexamic acid; fibrinolysis; post-partum haemorrhage; ancillary biologic study
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: CHUBX 2018/24; 2018-A01838-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No