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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00804453
Other study ID # 1455
Secondary ID ISRCTN15261860
Status Completed
Phase N/A
First received December 5, 2008
Last updated April 4, 2017
Start date November 2008
Est. completion date November 2008

Study information

Verified date April 2017
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.


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).


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients suffering from chronic renal failure,

- Patients treated in HD performed with or without heparin injection in the extra corporeal circuit (ECC) irrespective the type of heparin (UFH and LMWH),

- Patients treated three times a week for a minimum of three (3) months,

- Patients 18 years or older,

- Patients with a well-functioning vascular access as judged by the investigator,

- Patients with negative serologies (HIV, hepatitis),

- Patients having signed written informed consent to participate in the study.

Exclusion Criteria:

- Patients with known allergy to heparin,

- Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients,

- Active malignant disease,

- Pregnant women, nursing mothers and women planning a pregnancy during the course of the study,

- Patients under guardianship,

- Patients participating in other studies that could interfere with the objectives of this study,

- Patients treated in single needle mode,

- Patients with catheter,

- Patients receiving Anti-Vit K drug.

Study Design


Intervention

Device:
Cartridge blood set
Once a week
Standard blood line
Once a week

Locations

Country Name City State
France AURAL Bourgoin Jallieu

Sponsors (2)

Lead Sponsor Collaborator
Baxter Healthcare Corporation Gambro Lundia AB

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation. During dialysis treatment
Secondary 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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