Heparin Free Haemodialysis With Haemodialyzers "VIE" Versus "EVODIAL"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01221337
First received: October 14, 2010
Last updated: March 23, 2012
Last verified: October 2010
  Purpose

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 %.


Condition Intervention
Adult Chronic Haemodialysis Patients Since at Least 3 Months
Other: heparin free haemodialysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparative Study of Two Haemodialyzers "VIE 2.1" Versus "EVODIAL2.2" in a Strategy of Heparin-free Haemodialysis (HFH)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • The percentage of patients having completed the dialysis session without blood circuit clotting requiring early end of the session including two heparin-free haemodialysis. [ Time Frame: during every haemodialysis sessions ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of dialysis session without blood circuit clotting [ Time Frame: during every haemodialysis sessions ] [ Designated as safety issue: Yes ]
  • Number of times saline rinsing has been required [ Time Frame: during every haemodialysis ] [ Designated as safety issue: Yes ]
  • Degree of blood clots in the venous bubble trap [ Time Frame: during every haemodialysis sessions ] [ Designated as safety issue: Yes ]
  • Quality of blood restitution [ Time Frame: during every haemodialysis sessions ] [ Designated as safety issue: Yes ]
  • Dialysis adequacy (KT/V) [ Time Frame: during every haemodialysis sessions ] [ Designated as safety issue: Yes ]
  • Haematological status [ Time Frame: during every haemodialysis sessions ] [ Designated as safety issue: Yes ]
  • tolerance [ Time Frame: during every haemodialysis sessions ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
haemodialyzer EVODIAL-haemodialyzer VIE
Equal number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer.
Other: heparin free haemodialysis
Comparison of two haemodialyzers "VIE 2,1" versus "EVODIAL 2,2" in a strategy of heparin-free haemodialysis (HFH).
haemodialyzer VIE-haemodialyzer Evodial
Equal number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer.
Other: heparin free haemodialysis
Comparison of two haemodialyzers "VIE 2,1" versus "EVODIAL 2,2" in a strategy of heparin-free haemodialysis (HFH).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221337

Locations
France
Centre Hospitalier
Avignon, France, 84902
CHU de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Mohamed Shariful ISLAM, PH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01221337     History of Changes
Other Study ID Numbers: 10-PP-09
Study First Received: October 14, 2010
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014