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

ISRCTN	ISRCTN97876945
DOI	https://doi.org/10.1186/ISRCTN97876945
Secondary identifying numbers	1422

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mrs Kristina Hansson
Scientific

Clinical Affairs
Emdalavägen 5
P.O. Box 10101
Lund
220 10
Sweden

Study design	Open, multicentre, prospective non-randomised study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	To collect data to support European Conformity (CE)-marking of product.
Ethics approval(s)	Ethics Committee in Brussels and Ethics Committee in Lyon, approval pending as of 20/11/2006.
Health condition(s) or problem(s) studied	Chronic renal failure
Intervention	1. Investigational product: HEP-AN69ST 2. Control product: AN69AT This is a non-randomised study. All patients will have the following treatments: Week one: Three treatments with AN69ST (with usual heparin dose in the ECC) Week two: Three treatments with HEP-AN69ST with the same heparin dose in the ECC as in week one Week three: Three treatments with HEP-AN69ST with a 50% decrease in the heparin dose compared with weeks one and two
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Heparin
Primary outcome measure	Adverse events, particularly related to bleeding and premature clotting
Secondary outcome measures	1. Questionnaire to hospital staff regarding priming procedure 2. Dialysance-easurement 3. Rinse back evaluations
Overall study start date	15/12/2006
Completion date	30/04/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	30
Key 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
Key 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
Date of first enrolment	15/12/2006
Date of final enrolment	30/04/2007

Clinical Affairs

Lund
220 10
Sweden

Gambro Industries (France)
Industry

Clinical Affairs
61 avenue Tony Garnier
Lyon
FR-69357
France

Website	http://www.gambro.com/start.aspx?id=752
"ROR"	https://ror.org/01mgtdr23

Industry

Gambro Industries (France)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan