Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1465
Study information
Scientific title
Prismaflex ST150 versus M150 in different treatment's conditions: a prospective randomised cross-over study
Acronym
Study hypothesis
To 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
Study design
Prospective randomised cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Kidney disease
Intervention
1. 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 type
Drug
Pharmaceutical study type(s)
Phase
Phase IV
Drug/device/biological/vaccine name(s)
Prismaflex ST150, Prismaflex M150
Primary outcome measure
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).
Secondary outcome measures
Follow-up of adverse events (AE)/serious adverse events (SAE), assessed throughout the treatment.
Overall study start date
16/02/2009
Overall study end date
16/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
18
Participant 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.
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.
Recruitment start date
16/02/2009
Recruitment end date
16/02/2010
Locations
Countries of recruitment
Belgium
Study participating centre
Dept of Intensive Care
Leuven
3000
Belgium
Sponsor information
Organisation
Gambro Industries (France)
Sponsor details
7
Avenue Lionel Terray
Meyzieu
69883
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Gambro Industries (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|