Skip to content

Prismaflex ST150 versus M150 in different treatment's conditions

Prismaflex ST150 versus M150 in different treatment's conditions: a prospective randomised cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95194850
Enrollment
18
Registered
2009-02-24
Start date
2009-02-16
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney disease Urological and Genital Diseases Other disorders of kidney and ureter, not elsewhere classified

Interventions

1. Continuous veno-venous haemofiltration (CVVH) mode without heparin administration 2. Continuous veno-venous haemodiafiltration (CVVHDF) mode without heparin administration 3. Continuous veno-venous

Sponsors

Gambro Industries (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Filter 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

MeasureTime frame
Follow-up of adverse events (AE)/serious adverse events (SAE), assessed throughout the treatment.

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026