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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT05117450
Eligibility Criteria:
inclusion criteria :
* Patients with Age \> 18 years
* Chronic hemodialysis for at least 3 months
* Hemodialysis three times a week
* On per dialytic heparin therapy (UFH or LMWH)
* Affiliated to the French Social Security
* Having given their consent for this study
exclusion criteria :
* Patients undergoing Hemodiafiltration (HDF)
* Pregnant or lactating woman
* Patient participating in another interventional study
* Persons deprived of liberty by judicial or administrative decision
* Adults under legal protection (under guardianship or curators)
* Persons under a legal protection measure
* Patients with a history of HIT
* Patients with acquired or congenital coagulation disorders
* Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers)
* Patient on an ACE inhibitor (ACE inhibitor)
* Patient requiring transfusion during the study period
* Patient not hemoglobin-stabilized (mean Hb \< 10g/dL or \>12 g/dL in the previous month)
* Patient septic or with significant inflammation (defined as C-reactive protein \> 25mg/L) at the time of inclusion
* Patient requiring per-dialytic parenteral nutrition
* Patient requiring hospitalization or scheduled surgery during the study period
* Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (\< 300 mL/min determined during the screening phase = blood flow prescribed by the nephrologist)
* Patient dialyzing on catheter ("single line" or "double line") or in unipuncture on Arteriovenous fistula on the day of the screening session
* Net ultrafiltration on the day of the screening session \> 4000 mL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05117450
Study Brief:
Protocol Section:
NCT05117450