Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients (RESTIT)
Primary Purpose
Renal Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Decrease per-dialytic heparin therapy
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency
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
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HeprAN first
HYDROLINK first
Arm Description
Each included patient will have hemodialysis sessions with HeprAN membrane and then HYDROLINK
Each included patient will have hemodialysis sessions with HYDROLINK and then HeprAN membrane
Outcomes
Primary Outcome Measures
number of hemodialysis session success without heparin
The success of the hemodialysis session is defined by a dialysis time> 95% of the prescribed time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05117450
Brief Title
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
Acronym
RESTIT
Official Title
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
November 17, 2024 (Anticipated)
Study Completion Date
December 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed Description
The aim of this study is to compare the HYDROLINK™ membrane to the HeprAN™ membrane in a large-scale trial with the strategy of minimizing the dose of peridialytic heparin in order to reduce the risk of bleeding in chronic hemodialysis patients.
Participation in the research will be offered at the time of a hemodialysis session to any eligible patient, i.e., over 18 years of age, who has been on chronic hemodialysis for at least 3 months at a rate of three times a week and who has given their consent to this study. A cross over trial will be performed. Each included patient will have hemodialysis sessions with HYDROLINK™ and HeprAN™ membrane.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HeprAN first
Arm Type
Active Comparator
Arm Description
Each included patient will have hemodialysis sessions with HeprAN membrane and then HYDROLINK
Arm Title
HYDROLINK first
Arm Type
Active Comparator
Arm Description
Each included patient will have hemodialysis sessions with HYDROLINK and then HeprAN membrane
Intervention Type
Device
Intervention Name(s)
Decrease per-dialytic heparin therapy
Intervention Description
Decrease per-dialytic heparin therapy with the HYDROLINK membrane (dialyzer NV-21U, surface 2.1m², Toray industry, Tokyo, Japan) and with the HeprAN membrane (dialyzer Evodial 2.2, surface 2.15 m2, Hospal SAS, Meyzieu, France)
Primary Outcome Measure Information:
Title
number of hemodialysis session success without heparin
Description
The success of the hemodialysis session is defined by a dialysis time> 95% of the prescribed time
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine BRACONNIER
Phone
03 26 78 41 40
Ext
0033
Email
abraconnier@chu-reims.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe RIEU
Phone
03 26 78 76 38
Ext
0033
Email
prieu@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
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