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

Sponsor

CHU de Reims (Other)

Overall Status

Unknown status

CT.gov ID

NCT04462614

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Hemolysis VKA Anticoagulants / Administration & Dosage Coated Materials Biocompatible Heparin / Administration & Dosage Membranes Artificial Prospective Studies Renal Dialysis / Methods Renal Insufficiency / Therapy	Drug: Decrease per-dialytic heparin therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single-arm study 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 Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.

Arm

Intervention/Treatment

Experimental: single-arm study

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

Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.

Outcome Measures

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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damien JOLLY	Reims		France

Sponsors and Collaborators

CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHU de Reims

ClinicalTrials.gov Identifier:

NCT04462614

Other Study ID Numbers:

PO20091

First Posted:

Jul 8, 2020

Last Update Posted:

Jul 8, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Hemolysis

Heparin

Study Results

No Results Posted as of Jul 8, 2020