Prismaflex ST150 versus M150 in different treatment's conditions
| ISRCTN | ISRCTN95194850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95194850 |
| Protocol serial number | 1465 |
| Sponsor | Gambro Industries (France) |
| Funder | Gambro Industries (France) |
- 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
Scientific
Dept of Intensive Care
Herestraat 49
Leuven
3000
Belgium
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised cross-over study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prismaflex ST150 versus M150 in different treatment's conditions: a prospective randomised cross-over study |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Prismaflex ST150, Prismaflex M150 |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
Follow-up of adverse events (AE)/serious adverse events (SAE), assessed throughout the treatment. |
| Completion date | 16/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 18 |
| Key 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 |
| 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. 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 enrolment | 16/02/2009 |
| Date of final enrolment | 16/02/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Dept of Intensive Care
Leuven
3000
Belgium
3000
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
