Condition category
Urological and Genital Diseases
Date applied
04/10/2005
Date assigned
25/10/2005
Last edited
08/08/2007
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

ORCID ID

Contact details

University Hospital Gasthuisberg
Dept of Intensive Care
Herestraat 49
Leuven
3000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1441

Study information

Scientific title

Acronym

Study hypothesis

Evaluation of heparin-free treatment

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Continuous renal replacement therapy (CRRT)

Intervention

Please note that the first patient was recruited to this trial in November 2005 and the last patient completed the study in June 2007.

Each patient will be treated by maximum 4 filters (surface treated [ST] and non ST).
Randomisation of the sequence of treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary endpoint is 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). If the pressure changes are only temporary, treatment is continued. If they are permanent, the filter is discontinued with blood return.

Secondary outcome measures

Follow up of treatment safety: thrombopenia, bleeding episodes, transfusion requirement, treatment instability due to frequent filter changes.

Overall trial start date

26/09/2005

Overall trial end date

26/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients requiring 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, 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

40 (44 recruited as of end of study in June 2007)

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.

Recruitment start date

26/09/2005

Recruitment end date

26/09/2006

Locations

Countries of recruitment

Belgium

Trial participating centre

University Hospital Gasthuisberg
Leuven
3000
Belgium

Sponsor information

Organisation

Gambro Industries (France)

Sponsor details

61 av Tony Garnier BP7315
Lyon
69357
France

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Gambro Industries

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