HepZero:Heparin Free Dialysis With Evodial
Study Details
Study Description
Brief Summary
The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Heparin free dialysis standard of care Standard of care: can be either saline flushes or predilution (on-line or bags) |
Other: Heparin free dialysis technique
Saline flushes or predilution
Other Names:
|
| Experimental: Heparin free dialysis with Evodial
|
Device: Evodial
Evodial dialyer
|
Outcome Measures
Primary Outcome Measures
- Clotting of the dialysis session [During first dialysis session_Dialysis duration: 4 hours]
To evaluate the rate of successful treatments, clotting in the air traps will be evaluated using a scale grading from 1 to 4 and previously described in the literature. The first heparin free dialysis treatment will be considered successful when there is: No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), No additional saline flushes to prevent clotting, No change of dialyzer or blood lines because of clotting No premature stop (early rinse-back) because of clotting
Secondary Outcome Measures
- Clotting during consecutive dialysis session [2nd and 3rd consecutive dialysis sessions]
As for the first heparin free dialysis treatment, treatments will be considered successful when there is : No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), No additional saline flushes to prevent clotting, No change of dialyzer or blood lines because of clotting No premature stop (early rinse-back) because of clotting.
- Follow up of clotting during the dialysis sessions [During all dialysis sessions]
Grade 1: No detectable clotting Grade 2: Minimal clot formation (Presence of fibrinous ring) Grade 3: Clot formation (up to 5 cm) but dialysis still possible Grade 4: complete occlusion of air traps or dialyzer rendering dialysis impossible
- Efficacy [During all dialysis sessions]
Measurement of urea, creatinine and ionogramm, UF achieved
- Ease of use [During all dialysis sessions]
Collection of saline flushes performed (volume and time)
- Safety [During all dialysis sessions]
Follow-up of AEs/SAEs
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients requiring heparin free dialysis treatments on nephrologists' prescription,
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Chronic ESRD patients treated by maintenance hemodialysis for at least 3 months,
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Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min,
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Patients aged 18 years or more,
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Written consent to participate in the study (informed consent).
Exclusion Criteria:
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Patients in ICU settings,
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AKI patients,
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Patients dialyzed in self care, satellite HD units,
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Patients treated in single needle mode,
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Known heparin contraindication (HIT type II),
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Patients requiring blood and other labile blood products (i.e. fresh frozen plasma, platelets, etc …) transfusion during hemodialysis treatment,
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Patients receiving oral anticoagulants (including Anti vitamin K),
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Patients receiving a combination of anti-platelets agents,
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Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis,
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Pregnant/ planning pregnancy and lactating women during study period,
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Adult patients protected by the law,
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Patients are not affiliated to health insurance system (beneficiary or dependant)
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Participation in other interventional studies during the study period,
-
Patients that have already been included in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasme Hospital | Brussels | Belgium | ||
| 2 | George Dumont Hospital | Moncton | New Brunswick | Canada | |
| 3 | CHU Edouard Herriot | Lyon | France | ||
| 4 | CHU Brabois | Nancy | France | ||
| 5 | CHU de Saint-Étienne - Hôpital Nord | Saint-Priest en Jarez | France | 42270 | |
| 6 | UMCG | Groningen | Netherlands | ||
| 7 | Gdanski Uniwersytet Medyczny | Gdansk | Poland | ||
| 8 | Hospital Universitary German Trias i Pujol | Badalona | Spain | 08916 | |
| 9 | Vall d'Hebron Hospital | Barcelona | Spain | ||
| 10 | Royal Liverpool University Hospital | Liverpool | United Kingdom |
Sponsors and Collaborators
- Baxter Healthcare Corporation
- Statistical Analysis : CIC CHU Brabois Nancy
- Gambro Lundia AB
Investigators
- Study Chair: Maurice Laville, Pr, CHU Edouard Herriot Lyon
Study Documents (Full-Text)
None provided.More Information
Publications
- Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. Epub 2007 Dec 21.
- European Best Practice Guidelines Expert Group on Hemodialysis, European Renal Association. Section V. Chronic intermittent haemodialysis and prevention of clotting in the extracorporal system. Nephrol Dial Transplant. 2002;17 Suppl 7:63-71.
- Kim YG. Anticoagulation during haemodialysis in patients at high-risk of bleeding. Nephrology (Carlton). 2003 Oct;8 Suppl:S23-7. Review.
- Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75.
- Yixiong Z, Jianping N, Yanchao L, Siyuan D. Low dose of argatroban saline flushes anticoagulation in hemodialysis patients with high risk of bleeding. Clin Appl Thromb Hemost. 2010 Aug;16(4):440-5. doi: 10.1177/1076029609334628. Epub 2009 Oct 14.
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