AN69 surface treated (ST) versus AN69 in continuous renal replacement therapy (CRRT): a prospective randomized cross-over study without heparin in the extracorporeal circuit

ISRCTN	ISRCTN58520610
DOI	https://doi.org/10.1186/ISRCTN58520610
Secondary identifying numbers	1441

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Marie Schetz
Scientific

University Hospital Gasthuisberg
Dept of Intensive Care
Herestraat 49
Leuven
3000
Belgium

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	AN69 surface treated (ST) versus AN69 in continuous renal replacement therapy (CRRT): a prospective randomized cross-over study without heparin in the extracorporeal circuit
Study objectives	Evaluation of heparin-free treatment
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Continuous renal replacement therapy (CRRT)
Intervention	Please note that the first patient was recruited to this trial in November 2005 and the last patient completed the study in June 2007. Each patient will be treated by maximum 4 filters (surface treated [ST] and non ST). Randomisation of the sequence of treatment.
Intervention type	Other
Primary outcome measure	The primary endpoint is filter lifespan, defined as the time period between patients connection and filter disconnection. Filter clotting will be detected by following transmembrane pressure (TMP) and Filter Pressure Drop (FPD). If the pressure changes are only temporary, treatment is continued. If they are permanent, the filter is discontinued with blood return.
Secondary outcome measures	Follow up of treatment safety: thrombopenia, bleeding episodes, transfusion requirement, treatment instability due to frequent filter changes.
Overall study start date	26/09/2005
Completion date	26/09/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40 (44 recruited as of end of study in June 2007)
Total final enrolment	39
Key inclusion criteria	1. Patients requiring CRRT 2. Patients aged 18 and over 3. Patients weighing 30-120 kg 4. Patients having signed a written consent (informed consent) to participate in the study or, in case the patient is unable to understand and/or sign the consent form, written consent from a relative or, failing which, a person of trust
Key exclusion criteria	1. Suspicion of heparin-induced thrombocytopenia 2. Pregnancy 3. Patients requiring therapeutic anticoagulation for other indications e.g. valvular surgery or extracorporeal ventricular assist devices 4. Patients under guardianship 5. Patients 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. Current enrolment in another trial which could impact the successful completion of this study 7. Unconscious patients for whom no relative or person of trust can give consent for treatment. In the absence of any relative or person of trust, the patient in question cannot be included in the study.
Date of first enrolment	26/09/2005
Date of final enrolment	26/09/2006

University Hospital Gasthuisberg

Leuven
3000
Belgium

Gambro Industries (France)
Industry

61 av Tony Garnier BP7315
Lyon
69357
France

"ROR"	https://ror.org/01mgtdr23

Industry

Gambro Industries

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	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		07/07/2012	29/10/2021	Yes	No

EC 29/10/2021: Proactive update review. Added pub and total final enrolment.