HepZero:Heparin Free Dialysis With Evodial

Chronic Kidney Disease Clinical Trial

Official title:

HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318486
• Other study ID #: 1483
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: January 2022
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring heparin free dialysis treatments on nephrologists' prescription,

• Chronic ESRD patients treated by maintenance hemodialysis for at least 3 months,

• Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min,

• Patients aged 18 years or more,

• Written consent to participate in the study (informed consent).

Exclusion Criteria:

• Patients in ICU settings,

• AKI patients,

• Patients dialyzed in self care, satellite HD units,

• Patients treated in single needle mode,

• Known heparin contraindication (HIT type II),

• Patients requiring blood and other labile blood products (i.e. fresh frozen plasma, platelets, etc …) transfusion during hemodialysis treatment,

• Patients receiving oral anticoagulants (including Anti vitamin K),

• Patients receiving a combination of anti-platelets agents,

• Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis,

• Pregnant/ planning pregnancy and lactating women during study period,

• Adult patients protected by the law,

• Patients are not affiliated to health insurance system (beneficiary or dependant)

• Participation in other interventional studies during the study period,

• Patients that have already been included in this study.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Patients Requiring Heparin Free Dialysis Treatments
• Renal Insufficiency, Chronic

Intervention

Other:
• Heparin free dialysis technique
Saline flushes or predilution

Device:
• Evodial
Evodial dialyer

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels
Canada	George Dumont Hospital	Moncton	New Brunswick
France	CHU Edouard Herriot	Lyon
France	CHU Brabois	Nancy
France	CHU de Saint-Étienne - Hôpital Nord	Saint-Priest en Jarez
Netherlands	UMCG	Groningen
Poland	Gdanski Uniwersytet Medyczny	Gdansk
Spain	Hospital Universitary German Trias i Pujol	Badalona
Spain	Vall d'Hebron Hospital	Barcelona
United Kingdom	Royal Liverpool University Hospital	Liverpool

Sponsors (3)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Lundia AB, Statistical Analysis : CIC CHU Brabois Nancy

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Netherlands,  Poland,  Spain,  United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View Citation

Kim YG. Anticoagulation during haemodialysis in patients at high-risk of bleeding. Nephrology (Carlton). 2003 Oct;8 Suppl:S23-7. Review. — View Citation

Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clotting of the dialysis session	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	During first dialysis session_Dialysis duration: 4 hours
Secondary	Clotting during consecutive dialysis session	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.	2nd and 3rd consecutive dialysis sessions
Secondary	Follow up of clotting during the 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	During all dialysis sessions
Secondary	Efficacy	Measurement of urea, creatinine and ionogramm, UF achieved	During all dialysis sessions
Secondary	Ease of use	Collection of saline flushes performed (volume and time)	During all dialysis sessions
Secondary	Safety	Follow-up of AEs/SAEs	During all dialysis sessions