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

NCT04462614 | Unknown

• 1 other identifier: PO20091
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

single-arm study

EXPERIMENTAL

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

Interventions

Decrease per-dialytic heparin therapy DRUG

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

single-arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Antoine BRACONNIER

CONTACT

03 26 78 41 40; abraconnier@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 8, 2020
• Study Start: August 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

FR (1)