Assessment of heparin-free dialysis for patients with end-stage renal disease
Heparin-Free Chronic HemoDialysis Assessment
This study tests a new way to prevent blood clots during dialysis without using heparin to see if it’s safer for people with end-stage kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, Bouches du Rhône) |
| Trial ID | NCT06224140 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of heparin-free anticoagulation methods during intermittent hemodialysis for patients with end-stage renal disease (ESRD). The study focuses on minimizing the risks associated with heparin, such as bleeding complications and allergic reactions, while ensuring adequate anticoagulation to prevent clotting during dialysis. Participants will undergo hemodialysis with either heparin anticoagulation or a regional anticoagulation procedure (RAP) to assess outcomes related to safety and efficacy. The trial aims to identify a safer alternative to traditional heparin use in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with end-stage renal disease undergoing intermittent hemodialysis for at least three months.
Not a fit: Patients with dysfunctional vascular access or those currently receiving anticoagulation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risks associated with heparin use in dialysis patients, improving their overall safety and quality of life.
How similar studies have performed: While the use of heparin in dialysis is common, this study's focus on heparin-free methods represents a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man or woman aged 18 years or more * Patients with end-stage renal disease (ESRD) under intermittent hemodialysis, for more than 3 months prior to screening and with a dialysis duration prescription of at least 4 hours * Effective anticoagulation either by UFH or by LMWH of the dialysis session defined by the absence of circuit loss in the last 3 months. * Dialysis adequacy defined by a mean Kt/V ≥1.2. * Calcemia within the normal range at inclusion (2.2 to 2.6 mmol/L) (based on the results of the last monthly blood test) * Subject affiliated to or beneficiary of a social security system. * Subject having signed written informed consent. Exclusion Criteria: * Dysfunctional vascular access at the screening * Unipunction of the AVF * Patient treated by hemofiltration or hemodiafiltration procedure * Current anticoagulation treatment * Patient treated by digitalizing drugs * Patient treated by thiazide diuretics * Patient with hypercalcemia and/or hypercalciuria * History of sensitivity to heparin or heparin-induced thrombocytopenia. * Active hemorrhage * High bleeding risk defined by the following situations: recent bleeding of less than 7 days, recent post-operative period of less than 7 days, recent head trauma of less than 7 days, recent ischemic stroke of less than 7 days, uremic pericarditis. * Body weight \< 45 kg and \> 140 kg at screening. * Known allergy to citrate * Hospitalization at the screening for all other causes apart from dialysis * Moribund status (defined by the expectation of death in less than three months). * Liver failure (to prevent citrate liver toxicity) based on the results of the last monthly or quarterly blood test * Ongoing participation in a concurrent interventional study in dialysis or with anti-coagulation therapy * Pregnancy (declarative) or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without consent, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations * Patients unable to give an informed consent or unwilling to participate in the study. * Heparin-coated membrane in current dialysis prescription
Where this trial is running
Marseille, Bouches du Rhône
- Hôpital de la Conception — Marseille, Bouches du Rhône, France (Recruiting)
Study contacts
- Study coordinator: Thomas Robert
- Email: thomas.robert@ap-hm.fr
- Phone: 04 91 38 41 17
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.