Determination of Reference Values for Diluted Russell's Viper Venom Time (dRVVT) Specific to Pregnant Women (GRAPL)

Last updated: April 8, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Thrombosis

Treatment

dosage dRVVT

Clinical Study ID

NCT06133621
69HCL23_1016
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study Summary

Pregnancy is associated with significant changes in several aspects of haemostasis, especially an imbalance between procoagulant and anticoagulant factors. These changes contribute to creating a state of hypercoagulability, mainly at the end of pregnancy and during the post-partum period, protecting pregnant women from delivery haemorrhage, but exposing them to a major thromboembolic risk.

Vascular diseases of pregnancy (VDP) are obstetric diseases which are linked to an ischaemic origin associated with placental thrombosis. These include pre-eclampsia, retroplacental haematoma, intrauterine growth retardation and even foetal death in utero. A number of risk factors have been identified for these VDPs, some of which have extremely serious consequences, the main one being antiphospholipid syndrome (APS).

The diagnosis of VDP in a current or previous pregnancy requires close monitoring and joint management by an obstetrician, haemostasis physician, internist and medical biologist, particularly in terms of pre, peri- and post-partum anticoagulation in patients at increased risk of thromboembolism.

The aim of treating APS during pregnancy is : to reduce the occurrence of maternal arterial or venous thrombotic complications in one hand and in the other hand to reduce the occurrence of obstetric complications, which are responsible of a significant morbimortality rate. The detection of a possible APS during pregnancy will therefore determine the specific management of patients.

The latest guidelines from the Groupe Français d'Etude sur l'Hémostase et la Thrombose (GFHT) in 2022 recommended a diluted Russell's viper venom time (dRVVT) and an activated partial thromboplastin time (APTT) measured using a sensitive reagent such as silica (SCT) should be used to assess the presence of LA.

Eligibility Criteria

Inclusion

Inclusion Criteria: Control group :

  • patients with normal pregnancies at the HCL.
  • Affiliation to a social security regime Case group :
  • Patients followed at the HCL who had an increased dRVVT ratio during pregnancy,investigated as part of the development of VDP during pregnancy.
  • Affiliation to a social security regime

Exclusion

Exclusion Criteria:

  • History of thromboembolic disease
  • History of autoimmune disease
  • History of VDP

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: dosage dRVVT
Phase:
Study Start date:
March 28, 2024
Estimated Completion Date:
September 28, 2024

Study Description

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Connect with a study center

  • Dr Céline BAZIN

    Lyon,
    France

    Active - Recruiting

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