Anticoagulants / Administration & Dosage, Biocompatible, Chronic Hemolysis, Coated Materials, Heparin / Administration & Dosage, Membranes Artificial, Prospective Studies, Renal Dialysis / Methods, Renal Insufficiency / Therapy, VKA
Conditions
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.
Interventions
Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.
Sponsors
CHU de Reims
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France
Contacts
Primary ContactAntoine BRACONNIER
Outcome results
None listed