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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN15261860 |
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| Name | Class |
|---|---|
| Gambro Lundia AB | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.
Interactions between blood components (cells and proteins) and the extracorporeal circuit induce the activation of several biological systems such as platelets, complement and coagulation cascades. The coagulation system generates a key enzyme, factor IIa or thrombin, responsible for blood clotting in the dialysis circuit Because clotting in the circuit may reduce the dialysis efficiency, the anticoagulation of the extracorporeal circuit is needed .
For several years, most of the researches were mainly focused on the improvement of the biocompatibility of dialysis membranes .
The contribution of the various components of the dialysis circuit on the coagulation activation has not been clearly established.
A circuit integrating a cartridge blood set is commercialised for several years. The design of this cartridge blood set reduces the surface in contact with blood and minimizes the blood air interface which are well known sources of coagulation activation.
The aim of this study is to collect data to evaluate the biocompatibility of two types of blood circuit (cartridge blood set vs standard blood line).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Standard blood line |
|
| 2 | Experimental | Cartridge blood line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cartridge blood set | Device | Once a week |
| |
| Standard blood line |
| Measure | Description | Time Frame |
|---|---|---|
| The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation. | During dialysis treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of the restitution of both the filter and the circuit, at the end of each treatment, will be evaluated via visual scales. | End of dialysis treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid Arkouche, Dr | AURAL dialysis centre Lyon France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AURAL | Bourgoin | 38 317 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16433843 | Background | Lucchi L, Ligabue G, Marietta M, Delnevo A, Malagoli M, Perrone S, Stipo L, Grandi F, Albertazzi A. Activation of coagulation during hemodialysis: effect of blood lines alone and whole extracorporeal circuit. Artif Organs. 2006 Feb;30(2):106-10. doi: 10.1111/j.1525-1594.2006.00188.x. |
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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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| Device |
Once a week |
|
| 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 |