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| Name | Class |
|---|---|
| Statistical Analysis : CIC CHU Brabois Nancy | UNKNOWN |
| Gambro Lundia AB | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin free dialysis standard of care | Active Comparator | Standard of care: can be either saline flushes or predilution (on-line or bags) |
|
| Heparin free dialysis with Evodial | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin free dialysis technique | Other | Saline flushes or predilution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| During first dialysis session_Dialysis duration: 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clotting during consecutive dialysis session | As for the first heparin free dialysis treatment, treatments will be considered successful when there is :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Laville, Pr | CHU Edouard Herriot Lyon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Brussels | Belgium | ||||
| George Dumont Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15012687 | Background | Kim YG. Anticoagulation during haemodialysis in patients at high-risk of bleeding. Nephrology (Carlton). 2003 Oct;8 Suppl:S23-7. doi: 10.1046/j.1440-1797.8.s.3.x. | |
| 12386229 | Background | 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. doi: 10.1093/ndt/17.suppl_7.63. No abstract available. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Evodial | Device | Evodial dialyer |
|
| 2nd and 3rd consecutive dialysis sessions |
| Follow up of clotting during the dialysis sessions |
| During all dialysis sessions |
| Efficacy: Ultrafiltration | Measurement of urea, creatinine and ionogramm, UF achieved | During all dialysis sessions |
| Ease of use | Collection of saline flushes performed (volume and time) | During all dialysis sessions |
| Incidence of AEs/SAEs | Follow-up of AEs/SAEs | During all dialysis sessions |
| Moncton |
| New Brunswick |
| Canada |
| CHU Edouard Herriot | Lyon | France |
| CHU Brabois | Nancy | France |
| CHU de Saint-Étienne - Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |
| UMCG | Groningen | Netherlands |
| Gdanski Uniwersytet Medyczny | Gdansk | Poland |
| Hospital Universitary German Trias i Pujol | Badalona | 08916 | Spain |
| Vall d'Hebron Hospital | Barcelona | Spain |
| Royal Liverpool University Hospital | Liverpool | United Kingdom |
| 18156457 | Background | 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. doi: 10.1093/ndt/gfm888. Epub 2007 Dec 21. |
| 1760540 | Background | Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75. doi: 10.1681/ASN.V25961. |
| 19833621 | Background | 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. |
| 38189593 | Derived | Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2. |
| 25007166 | Derived | Laville M, Dorval M, Fort Ros J, Fay R, Cridlig J, Nortier JL, Juillard L, Debska-Slizien A, Fernandez Lorente L, Thibaudin D, Franssen C, Schulz M, Moureau F, Loughraieb N, Rossignol P. Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis. Kidney Int. 2014 Dec;86(6):1260-7. doi: 10.1038/ki.2014.225. Epub 2014 Jul 9. |
| 23725299 | Derived | Rossignol P, Dorval M, Fay R, Ros JF, Loughraieb N, Moureau F, Laville M. Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial. Trials. 2013 Jun 1;14:163. doi: 10.1186/1745-6215-14-163. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |