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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN 93952087 |
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| Name | Class |
|---|---|
| Gambro Lundia AB | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.
In parallel to the new hemodialyzer, Evodia blood lines were developed to improve characteristics of the extracorporeal circuit in term of reduced activation of the coagulation system and lower deposits of clot components.
The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low thrombogenicity and that can be used with low heparin dose in order to reduce the patients' bleeding risk at the end of HD treatment.
Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the coagulation, will be performed during the study in order to evaluate the thrombogenicity of the system.
The ionic clearance will be collected during all treatments to evaluate the performance of the hemodialyzer.
The study will be divided into three steps
Each patient included into the study will perform the three steps. As the risk of extracorporeal circuit clotting will be rather important, no control group (usual hemodialyzer with heparin decrease dose) will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treatment with Evodial with reduction of heparin across study period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evodial hemodialysers and Evodia blood lines | Device | Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary criterion is the measurement of Anti Xa at the end of dialysis sessions. | End of dialysis treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up of aPTT for patients treated with UFH, | Kinetic on single dialysis treatment | |
| Evaluation of TAT (Thrombin-Antithrombin) complex, | Kinetic on single dialysis treatment | |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michèle Kessler, Pf | Hopital Brabois, Vandoeuvre les Nancy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calydial dialysis unit | Irigny | 69540 | France | |||
| Clinique St Exupéry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13679486 | Background | Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104. doi: 10.1093/ndt/gfg272. | |
| 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Follow-up of ionic clearance (Diascan) measurements during HD sessions, |
| Kinetic of single dialysis treatment |
| Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale, | End of dialysis treatment |
| Follow-up of AE/SAE. | All treatments during study period |
| Toulouse |
| 31400 |
| France |
| Hopital Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| ALTIR Dialysis center | Vandœuvre-lès-Nancy | France |
| Medizinische Hochschule | Hanover | 30625 | Germany |
| Borgo Trento Hospital | Verona | Italy |
| Karolinska Hospital | Stockholm | Sweden |
| 22925178 | Derived | Kessler M, Gangemi C, Gutierrez Martones A, Lacombe JL, Krier-Coudert MJ, Galland R, Kielstein JT, Moureau F, Loughraieb N. Heparin-grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: a prospective proof-of-concept study. Hemodial Int. 2013 Apr;17(2):282-93. doi: 10.1111/j.1542-4758.2012.00733.x. Epub 2012 Aug 23. |
| D052776 |
| Female Urogenital Diseases |
| 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 |