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

Prospective Studies Clinical Trial

— REMARK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04462614
• Other study ID #: PO20091
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: July 2021

Study information

• Verified date: July 2020
• Source: CHU de Reims
• Contact: Antoine BRACONNIER
• Phone: 03 26 78 41 40
• Email: abraconnier[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 49
• Est. completion date: July 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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