Trials / Completed
CompletedNCT00804453
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Vantive Health LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cartridge blood set | Once a week |
| DEVICE | Standard blood line | Once a week |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2008-11-01
- Completion
- 2008-11-01
- First posted
- 2008-12-08
- Last updated
- 2025-03-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00804453. Inclusion in this directory is not an endorsement.