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Possibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA (REMARK)

Primary Purpose

Chronic Hemolysis, VKA, Anticoagulants / Administration & Dosage

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Decrease per-dialytic heparin therapy
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hemolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

inclusion criteria :

  • 18 years old and older
  • chronic hemodialysis for at least 3 months
  • treated by long-term anticoagulation with VKA
  • hemodialysis with the HeprAN® membrane
  • per dialytic heparin therapy (UFH or LMWH)
  • dialyzed at Reims University Hospital
  • agreeing to participate in the study

Exclusion criteria

  • chronic hemodialysis without per dialytic heparin
  • Patient dialized with single lumen catheter for vascular access
  • less than 18 years old
  • pregnant or lactating women
  • protected by law

Sites / Locations

  • Damien JOLLY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm study

Arm Description

Chronic hemodialysis patients for at least 3 months at Reims University Hospital, treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane

Outcomes

Primary Outcome Measures

Failure of heparin withdrawal in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane, verify adequate dialysis parameters
Failure is defined by early interruption of the dialysis session (<95% of the prescribed time) for : extracorporeal circuit coagulation recurrent venous pressure alarm causing blood pump shutdown or Lower quality of dialysis compared to the quality before stopping perdialytic anticoagulation (defined as Kt/V less than - 2SD for 3 consecutive sessions)

Secondary Outcome Measures

Full Information

First Posted
July 3, 2020
Last Updated
July 3, 2020
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT04462614
Brief Title
Possibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA
Acronym
REMARK
Official Title
Feasibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
July 2021 (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

5. Study Description

Brief Summary
Use HeprAN ™ membrane (coated with heparin) should be allow the success of dialysis sessions, with adequate dialysis parameters, in patients treated by long-term anticoagulation with VKA, without addition of heparin perdialytic. Less use of heparin (UFH or LMWH) during hemodialysis session should be allow a decrease of bleedings (moderate or major) and blood transfusions for hemodialysed patients with HeprAN ™ membrane and treated by long-term anticoagulation with VKA
Detailed Description
The aim will be to study possibility of hemodialysis sessions success, without perdialytic anticoagulation but with adequate dialysis parameters (defined by the patient's Kt / V machine), in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hemolysis, VKA, Anticoagulants / Administration & Dosage, Coated Materials, Biocompatible, Heparin / Administration & Dosage, Membranes Artificial, Prospective Studies, Renal Dialysis / Methods, Renal Insufficiency / Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-arm study
Arm Type
Experimental
Arm Description
Chronic hemodialysis patients for at least 3 months at Reims University Hospital, treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane
Intervention Type
Drug
Intervention Name(s)
Decrease per-dialytic heparin therapy
Intervention Description
Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.
Primary Outcome Measure Information:
Title
Failure of heparin withdrawal in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane, verify adequate dialysis parameters
Description
Failure is defined by early interruption of the dialysis session (<95% of the prescribed time) for : extracorporeal circuit coagulation recurrent venous pressure alarm causing blood pump shutdown or Lower quality of dialysis compared to the quality before stopping perdialytic anticoagulation (defined as Kt/V less than - 2SD for 3 consecutive sessions)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria : 18 years old and older chronic hemodialysis for at least 3 months treated by long-term anticoagulation with VKA hemodialysis with the HeprAN® membrane per dialytic heparin therapy (UFH or LMWH) dialyzed at Reims University Hospital agreeing to participate in the study Exclusion criteria chronic hemodialysis without per dialytic heparin Patient dialized with single lumen catheter for vascular access less than 18 years old pregnant or lactating women protected by law
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
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine BRACONNIER
Phone
03 26 78 41 40
Ext
0033
Email
abraconnier@chu-reims.fr

12. IPD Sharing Statement

Learn more about this trial

Possibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA

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