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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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VKA, Chronic Hemolysis, Anticoagulants / Administration & Dosage, Coated Materials, Biocompatible, Heparin / Administration & Dosage, Membranes Artificial, Prospective Studies, Renal Dialysis / Methods, Renal Insufficiency / Therapy

Intervention / Treatment
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* Drug: Decrease per-dialytic heparin therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm study<br>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 | Drug: Decrease per-dialytic heparin therapy<br>* Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 weeks |