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

CHU de Reims

Status: Unknown

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

Treatments: Drug: Decrease per-dialytic heparin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04462614

PO20091

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

single-arm study

Experimental group

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

Treatment:

Drug: Decrease per-dialytic heparin therapy