Prismaflex ST150 versus M150 in different treatment's conditions

ISRCTN ISRCTN95194850
DOI https://doi.org/10.1186/ISRCTN95194850
Secondary identifying numbers 1465
Submission date
03/02/2009
Registration date
24/02/2009
Last edited
24/02/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
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

Contact information

Prof Marie Schetz University Hospital Gasthuisberg
Scientific

Dept of Intensive Care
Herestraat 49
Leuven
3000
Belgium

Study information

Study designProspective randomised cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePrismaflex ST150 versus M150 in different treatment's conditions: a prospective randomised cross-over study
Study objectivesTo validate the conclusion of a previous study: 'AN69 surface treated (ST) versus AN69 in continuous renal replacement therapy (CRRT): a prospective randomised cross-over study without heparin in the extracorporeal circuit' [ISRCTN58520610] (see http://www.controlled-trials.com/ISRCTN58520610).
Ethics approval(s)Commissie Medische Ethiek Van de Universitair Ziekenhuizen Kuleuven gave approval in January 2009
Health condition(s) or problem(s) studiedKidney disease
Intervention1. Continuous veno-venous haemofiltration (CVVH) mode without heparin administration
2. Continuous veno-venous haemodiafiltration (CVVHDF) mode without heparin administration
3. Continuous veno-venous haemodiafiltration (CVVHDF) mode with heparin administration

Each patient will be treated by a maximum of 4 filters (surface treated [ST] and non-ST).
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Prismaflex ST150, Prismaflex M150
Primary outcome measureFilter lifespan, defined as the time period between patient’s connection and filter disconnection. Filter clotting will be detected by following transmembrane pressure (TMP) and Filter Pressure Drop (FPD).
Secondary outcome measuresFollow-up of adverse events (AE)/serious adverse events (SAE), assessed throughout the treatment.
Overall study start date16/02/2009
Completion date16/02/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants18
Key inclusion criteria1. Patients requiring continuous renal replacement therapy (CRRT)
2. Patients aged 18 and over, either sex
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 criteria1. 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.
8. Patients with high bleeding risk according to investigator and that cannot be treated with heparin. These patients should not be included in the therapy group continuous veno-venous haemodiafiltration (CVVHDF) with heparin administration.
Date of first enrolment16/02/2009
Date of final enrolment16/02/2010

Locations

Countries of recruitment

  • Belgium

Study participating centre

Dept of Intensive Care
Leuven
3000
Belgium

Sponsor information

Gambro Industries (France)
Industry

7, Avenue Lionel Terray
Meyzieu
69883
France

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

Funders

Funder type

Industry

Gambro Industries (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan