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Pilot, prospective, multicentric, open study: use of a new Prismaflex filter (coated with heparin) without any addition of heparin in the extracorporeal circuit. Study with direct individual benefit.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN02674550
Enrollment
30
Registered
2006-02-28
Start date
2005-11-30
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

Continuous Renal Replacement Therapy (CRRT) Urological and Genital Diseases Continuous Renal Replacement Therapy (CRRT)

Interventions

Patients are treated with a maximum five filters. Please note that the study period of this trial has been extended to December 2007.

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 3. Patients weighing 30-120 kg 4. Patients having signed a written consent (informed consent) to participate in the study or written consent from a relative or, failing which, a person of trust in case the patient is unconscious

Exclusion criteria

Exclusion criteria: 1. History of heparin antibodies or heparin-induced thrombocytopenia 2. Known hypersensitivity to any dialysis membrane 3. Pregnancy 4. Current enrolment in another trial which could impact the successful completion of this study 5. Patients under guardianship 6. Patients anticipated to require transportation outside the unit for diagnostic or therapeutic procedures in the coming first week 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.

Design outcomes

Primary

MeasureTime frame
Evaluation of filters? lifespan in patients treated by CRRT with the new products without any addition of heparin in the extracorporeal circuit

Secondary

MeasureTime frame
Safety assessment of heparin-free treatment

Countries

France

Outcome results

None listed

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