Evaluation of a new pre-heparinised filter: a multicentre, open, prospective pilot study

Completed

• Conditions: Chronic renal failure; Urological and Genital Diseases; Renal Failure

• Registration Number: ISRCTN97876945
• Lead Sponsor: Gambro Industries (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Patients suffering from chronic renal failure
2. Patients treated in Haemodialysis (HD) unit performed with or without heparin injection in the Extra Corporeal Circuit (ECC)
3. Patients treated three times a week with AN69ST for a minimum of one month
4. Patients 18 years or older
5. Patients with a well-functioning vascular access as judged by the investigator
6. Signed written informed consent to participate in the study

Exclusion Criteria

1. Patients with known allergy to heparin
2. Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients
3. Pregnant women, nursing mothers and women planning a pregnancy during the course of the study
4. Patients under guardianship
5. Patients participating in other studies that could interfere with the objectives of this study
6. Patients treated in single needle mode
7. Patients treated in HD with low molecular weight heparin injection in the ECC
8. Patients with catheter

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events, particularly related to bleeding and premature clotting

Secondary Outcome Measures

Name	Time	Method
1. Questionnaire to hospital staff regarding priming procedure<br>2. Dialysance-easurement<br>3. Rinse back evaluations