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

Not Applicable

• Conditions: Heparin / Administration & Dosage; Renal Dialysis / Methods; Renal Insufficiency / Therapy; Chronic Hemolysis; VKA; Anticoagulants / Administration & Dosage; Biocompatible; Membranes Artificial; Prospective Studies; Coated Materials
• Interventions: Drug: Decrease per-dialytic heparin therapy

• Registration Number: NCT04462614
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-03
• Last Update Submitted: 2020-07-03
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08
• Study Start: 2020-08
• Primary Completion: 2021-01
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm study	Decrease per-dialytic heparin therapy	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

Primary Outcome Measures

Name	Time	Method
Failure of heparin withdrawal in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane, verify adequate dialysis parameters	3 weeks	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)

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France