Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05117450

Comparison of HYDROLINK22 and HeprAN22 Membranes in a Per Dialytic Heparin Reduction Strategy for Chronic Hemodialysis Patients

Led by CHU de Reims · Updated on 2025-11-21

302

Participants Needed

1

Research Sites

4 weeks

Total Duration

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AI-Summary

What this Trial Is About

Chronic kidney disease (CKD) causes ongoing and irreversible damage to the kidneys, often requiring replacement therapies like hemodialysis or kidney transplant. Hemodialysis, the main treatment, can trigger blood clotting that disrupts the treatment session, leading to less effective dialysis and blood loss, especially in patients who commonly have anemia and bleeding risks due to their kidney condition and related medications. To address this, membranes coated with heparin, like the HeprAN22 membrane, have been developed to reduce the need for anticoagulants during dialysis sessions, lowering bleeding risks. The HYDROLINK22 membrane offers a similar advantage but works without heparin, potentially avoiding related complications. This research compares the HYDROLINK22 membrane with the HeprAN22 membrane in a large trial aiming to reduce the dose of heparin used during dialysis to lower bleeding risk. Eligible patients aged 18 and over, on chronic hemodialysis three times a week for at least three months, will participate. The study uses a crossover design where each patient undergoes dialysis sessions with both membranes in different sequences to directly compare their effects. Participants will receive dialysis with the assigned membrane and have their sessions monitored for success without the use of heparin over a four-week period. Researchers will assess the number of successful hemodialysis sessions without heparin and monitor safety and treatment tolerability. The study involves regular hemodialysis sessions and ongoing evaluation to understand if the membranes help minimize anticoagulant use while maintaining effective dialysis treatment.

CONDITIONS

Brief Title

Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged over 18 years
  • On chronic hemodialysis for at least 3 months
  • Undergoing hemodialysis three times a week
  • Receiving per dialytic heparin therapy (unfractionated or low molecular weight heparin)
  • Affiliated with French Social Security
  • Have given consent to participate in the study
Not Eligible

You will not qualify if you...

  • Patients undergoing hemodiafiltration (HDF)
  • Pregnant or breastfeeding women
  • Participants in another interventional study
  • Individuals under judicial or administrative detention
  • Adults under legal protection (guardianship or curatorship)
  • Patients with a history of heparin-induced thrombocytopenia (HIT)
  • Patients with acquired or congenital coagulation disorders
  • Active cancer diseases including myeloma, Waldenstr�f6m disease, or solid tumors
  • Patients taking ACE inhibitors
  • Patients requiring blood transfusion during the study
  • Patients with unstable hemoglobin levels (mean Hb < 10g/dL or >12g/dL in the past month)
  • Patients with sepsis or significant inflammation (C-reactive protein > 25mg/L) at inclusion
  • Patients needing per-dialytic parenteral nutrition
  • Patients requiring hospitalization or planned surgery during the study
  • Vascular access not allowing sufficient blood pump flow (< 300 mL/min)
  • Patients dialyzing with a catheter or unipuncture on arteriovenous fistula at screening
  • Net ultrafiltration greater than 4000 mL on screening day

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - 4 weeks

Participants undergo hemodialysis sessions using the HYDROLINK™ membrane and the HeprAN™ membrane in a crossover design with a strategy to minimize per-dialytic heparin dose to reduce bleeding risk.

Hemodialysis sessions three times a week with each membrane

Trial Site Locations

Total: 1 location

1

Chu Reims

Reims, France, 51092

Actively Recruiting

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Research Team

A

Antoine BRACONNIER

P

Philippe RIEU

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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