Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT05422157
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05422157
Study Brief:
Protocol Section:
NCT05422157