Comparing two types of membranes to reduce heparin use in dialysis patients
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
This study is testing two different types of dialysis membranes to see if they can help reduce the amount of heparin needed during treatment for people with chronic kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT05117450 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of HYDROLINK™ and HeprAN™ membranes in minimizing the dose of peridialytic heparin during hemodialysis sessions for patients with chronic kidney disease. By reducing heparin use, the study seeks to lower the risk of bleeding complications associated with hemodialysis. Eligible participants are adults over 18 years who have been on chronic hemodialysis for at least three months. The study will employ a crossover design, allowing each patient to experience both membrane types during their treatment sessions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years who have been on chronic hemodialysis for at least three months and are currently receiving peridialytic heparin therapy.
Not a fit: Patients undergoing hemodiafiltration, those with active neoplasia, or individuals with coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of bleeding in chronic hemodialysis patients while maintaining effective dialysis treatment.
How similar studies have performed: While the approach of minimizing heparin use in dialysis is known, the specific comparison of these two membrane types in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Reims
- Chu Reims — Reims, France (Recruiting)
Study contacts
- Study coordinator: Antoine BRACONNIER
- Email: abraconnier@chu-reims.fr
- Phone: 03 26 78 41 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.