Evaluation of lifespan in AN69ST with two different heparinization strategies

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

Dr Beng-Åke Henriksson
Scientific

Sahlgrenska University Hospital
Department of Intensive Care (CIVA)
Gothenburg
SE- 413 45
Sweden

Primary study design	Interventional
Study design	Monocentric, open, randomised and controlled study with two parallel groups.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Reduction of heparin dose in acute renal failure treated with hemodiafiltration.
Ethics approval(s)	Local research ethics committee, Göteborg, Sweden. Date of approval: 17/12/2007 (Dnr. 576-07)
Health condition(s) or problem(s) studied	Acute renal failure/ fluid overload
Intervention	The same dialysis membrane, AN69ST, will be used for both the intervention and control treatment. Two different heparinization strategies will be compared: Control group (usual heparin doses): Bolus at start (between 1,000 IU - 2,500 IU) + usual infusion dose (10 IU/kg/h) Intervention group (Reduction of heparin dose): No bolus at start + infusion decreased by 50% (5 IU/kg/h)
Intervention type	Other
Primary outcome measure(s)	Filter lifespan, defined as the time period between patient's connection and filter disconnection due to filter clotting.
Key secondary outcome measure(s)	Adverse events, monitored for up to 24 days of treatment
Completion date	01/01/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	44
Key inclusion criteria	1. Patients requiring continuous renal replacement therapies (CRRT) 2. Aged 18 and over 3. Patients weighing 30-120 kg 4. Patients having signed a written consent to participate in the study
Key exclusion criteria	1. History of heparin antibodies or heparin-induces thrombocytopenia 2. Known hypertensive to any dialysis membrane 3. Current enrolment in another trial which could impact the successful completion of this study 4. Patients under guardianship 5. Patient anticipated to require transportation outside the unit for diagnostic or therapeutic procedures in the coming first week .These patients can eventually be included in a later more stable phase 6. Unconscious patients for whom no relative or person of trust can give consent to treatment. In the absence of any relative or person of trust, the patient in question cannot be included in the study 7. Patient requiring anticoagulation for other indications e.g., valvular surgery or extracorporeal ventricular assist devices 8. Patients with active bleeding who does not require heparinization
Date of first enrolment	12/02/2008
Date of final enrolment	01/01/2010

Sahlgrenska University Hospital

Gothenburg
SE- 413 45
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes