Condition category
Urological and Genital Diseases
Date applied
03/02/2009
Date assigned
24/02/2009
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marie Schetz University Hospital Gasthuisberg

ORCID ID

Contact details

Dept of Intensive Care
Herestraat 49
Leuven
3000
Belgium

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Phase IV

Drug names

Prismaflex ST150, Prismaflex M150

Primary outcome measures

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 outcome measures

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

Overall trial start date

16/02/2009

Overall trial end date

16/02/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes