Evaluation of lifespan in AN69ST with two different heparinization strategies

ISRCTN	ISRCTN01121161
DOI	https://doi.org/10.1186/ISRCTN01121161
Secondary identifying numbers	1446

Prospectively registered

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Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Dr Beng-Åke Henriksson
Scientific

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

Study design	Monocentric, open, randomised and controlled study with two parallel groups.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (in Swedish only)
Scientific title
Study hypothesis	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)
Condition	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	Filter lifespan, defined as the time period between patient's connection and filter disconnection due to filter clotting.
Secondary outcome measures	Adverse events, monitored for up to 24 days of treatment
Overall study start date	12/02/2008
Overall study end date	01/01/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	44
Participant 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
Participant 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
Recruitment start date	12/02/2008
Recruitment end date	01/01/2010

Sahlgrenska University Hospital

Gothenburg
SE- 413 45
Sweden

Gambro Lundia AB (Sweden)
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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
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