Clinical trial NCT01221337: Heparin Free Haemodialysis With Haemodialyzers "VIE" Versus "EVODIAL"
Official title: Comparative Study of Two Haemodialyzers "VIE 2.1" Versus "EVODIAL2.2" in a Strategy of Heparin-free Haemodialysis (HFH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Chronic Haemodialysis Patients Since at Least 3 Months
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.


Eligibility criteria: Inclusion Criteria:

-- Adult chronic haemodialysis patients since al least 3 months

* Two needles puncture of the fistula,
* Low molecular weight heparinization during haemodialysis sessions,
* Good fistula or central veinous catheter flow rate (blood pump flow rate ≥ 300 ml/min),
* Systolic blood pressure ≥ 110 mmHg (mean value of three last dialysis sessions.
* Patients capable to understand the design of the study and to follow the instructions
* Patients having the French social security system affiliation.

Non-inclusion criteria :

* C reactive protein \> 30 mg/L.
* Single needle puncture of the fistula
* Active documented haemorrhage,
* Haemoglobin \< 10 g/dl and/or need blood transfusion,
* Documented thrombophilia
* Patients waiting for renal graft
* Acute sepsis
* Fistula or catheter dysfunction
* Patients under anti-vitamine K
* Per dialytic hypotension requiring al least once a nurse intervention,
* Severe diseases (Dysglobulinemia, vascularitis, HIV...),
* Patients following another research protocol or have ended one less then one month before starting of this study.
* Pregnant or breast feeding patients,
* Minor patients or under law-protection

Primary outcomes:
measure: The percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions
timeFrame: during every haemodialysis sessions
Secondary outcomes:
measure: Duration of dialysis session without blood circuit clotting
timeFrame: during every haemodialysis sessions
measure: Number of times saline rinsing has been required
timeFrame: during every haemodialysis
measure: Degree of blood clots in the venous bubble trap
timeFrame: during every haemodialysis sessions
measure: Quality of blood restitution
timeFrame: during every haemodialysis sessions
measure: Dialysis adequacy (KT/V)
timeFrame: during every haemodialysis sessions
measure: Haematological status
timeFrame: during every haemodialysis sessions
measure: tolerance
timeFrame: during every haemodialysis sessions
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Mohamed Shariful ISLAM, PH
role: PRINCIPAL_INVESTIGATOR
References: