Status:
COMPLETED
Heparin Free Haemodialysis With Haemodialyzers "VIE" Versus "EVODIAL"
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Adult Chronic Haemodialysis Patients Since at Least 3 Months
Eligibility:
All Genders
18+ years
Phase:
NA
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 haemodialys...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01221337
Start Date
October 1 2010
End Date
February 1 2011
Last Update
June 13 2016
Active Locations (2)
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1
Centre Hospitalier
Avignon, France, 84902
2
CHU de Nice
Nice, France, 06000