![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
Gambro Lundia AB |
---|---|
Information provided by: | Gambro Lundia AB |
ClinicalTrials.gov Identifier: | NCT00804453 |
The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Failure |
Device: Cartridge blood set Device: Standard blood line |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-Over Study. |
Estimated Enrollment: | 25 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | June 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Standard blood line
|
Device: Standard blood line
Once a week
|
2: Experimental
Cartridge blood line
|
Device: Cartridge blood set
Once a week
|
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Gambro Lundia AB ( Nathalie Loughraïeb Study Manager ) |
Study ID Numbers: | 1455, ISRCTN15261860 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804453 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Chronic Kidney Failure Hemodialysis Biocompatibility |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |