Haemostasis and Tranexamic Acid in Caesarean Delivery

NCT03742947 | Completed

• 1 other identifier: CHUBX 2018/24
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Postpartum Hemorrhage; Hyperfibrinolysis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Lysis Timer clot lysis time

  Time 15min and Time 120min (defined as 15 minutes 120 minutes after the administration of the product, respectively)

• Routine clot lysis time

  Baseline, Time 15min, and Time 120min

• t-PA

  Baseline, Time 15min, and Time 120min

• PAI-1

  Baseline, Time 15min, and Time 120min

• PAI-2

  Baseline, Time 15min, and Time 120min

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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

Diagnostic Test: peripartum haemostasis

Chloride solution

PLACEBO COMPARATOR

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

Diagnostic Test: peripartum haemostasis

Interventions

peripartum haemostasis 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; Tranexamic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

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

Study Sites (1)

CHU Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 15, 2018
• Study Start: January 10, 2019
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)