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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure. To avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology. In this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA. The HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Reims
RECRUITING
Reims
Contact Information
Primary
Antoine BRACONNIER
abraconnier@chu-reims.fr
03 26 78 41 40
Backup
Philippe RIEU
prieu@chu-reims.fr
03 26 78 76 38
Time Frame
Start Date: 2021-11-17
Estimated Completion Date: 2025-12-17
Participants
Target number of participants: 302
Treatments
Active_comparator: HeprAN first
Each included patient will have hemodialysis sessions with HeprAN membrane and then HYDROLINK
Active_comparator: HYDROLINK first
Each included patient will have hemodialysis sessions with HYDROLINK and then HeprAN membrane
Related Therapeutic Areas
Sponsors
Leads: CHU de Reims

This content was sourced from clinicaltrials.gov