Status:
COMPLETED
Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Diagnostica Stago
Conditions:
Patients Without a Medical History of Thrombosis or Hemorrhage
Hemophilic Patient
Eligibility:
All Genders
18+ years
Brief Summary
The thrombin generation test is a global test for the study of coagulation that allows the fine study of the balance between procoagulant and anticoagulant factors. For many years, it has been perform...
Detailed Description
A preliminary step in the development of multi-center protocols is to confirm that inter-center variability is acceptable on ST Genesia, and even more acceptable than it was on Calibrated Automated Th...
Eligibility Criteria
Inclusion
- Major patient, male or female
- Affiliated to a social security system
- In capacity to express informed consent to participate in research
- Control group: 5 men, 5 women without oral contraception, 5 women with oral contraception and apparently healthy with a respect to hemostasis (no history of thrombosis or significant bleeding on examination)
- Hemophilia groups: - 5 hemophiliacs A (treated or untreated), with predictable FVIII:C levels between \< 1% and 40%.
- 5 hemophiliacs B (treated or not), with predictable FIX:C levels between \< 1% and 40%.
- FV Leiden group: 5 patients known to be heterozygous or homozygous for the R506Q mutation of the F5 gene (the so-called "Factor V Leiden" mutation)
- Cirrhosis group: - 5 patients with Child-Pugh A
- 5 patients with Child-Pugh B
- 5 patients with Child-Pugh C
- Anticoagulation group: - 5 patients on anti-vitamin K therapy for at least 1 month, with INR between 2 and 4
- 5 patients on apixaban for at least 1 week
- 5 patients on rivaroxaban for at least 1 week
- 5 patients on dabigatran for at least 1 week
- 5 patients on low molecular weight heparin for at least 1 day
Exclusion
- Refusal to participate
- Patient under protective measures (guardianship, curatorship) or under judicial protection
- Minor patients
- Moderate to end-stage renal failure
- Proven inflammatory state/infectious syndrome (body temperature \> 38°C and/or clinical signs suggestive of infection) during or in the week prior to collection, at the discretion of the investigator
- Transfusion in the week prior to collection
- Pregnant or breastfeeding woman
- Contraception by estrogen-progestin, except for the control group concerned
- Anticoagulation of less than one week, except for the anticoagulation group
- Control group: - Presence of drug treatment known to interfere with hemostasis
- Presence of a pathology known to interfere with hemostasis such as renal or hepatic insufficiency
- Presence of a history of venous thromboembolic disease or diagnosed hemorrhagic disease
- Predicted inclusion hemoglobin level \< 7g/L
- Hemophilic groups: - Presence of anti FVIII or anti FIX inhibitors
- Treatment with emicizumab
- Predicted inclusion hemoglobin level \< 7g/L
- FV Leiden group: - Presence of anticoagulant therapy at the time of collection
- Predicted baseline hemoglobin \< 7g/L
- Anticoagulation group: - Anticoagulant therapy not stabilized as determined by the practitioner
- Presence of a therapeutic relaunch in progress
- Hemoglobin at predicted inclusion \< 9-10g/L
- Cirrhosis group: Predicted inclusion hemoglobin level \< 7g/L
Key Trial Info
Start Date :
September 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05422157
Start Date
September 7 2022
End Date
November 10 2023
Last Update
July 12 2024
Active Locations (1)
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1
CHU clermont-ferrand
Clermont-Ferrand, France