Condition category
Urological and Genital Diseases
Date applied
02/02/2006
Date assigned
28/02/2006
Last edited
22/12/2006
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 Bernard Allaouchiche

ORCID ID

Contact details

Hôpital Edouard Herriot
Service d’Anesthésie-Réanimation
Pavillon G
5 Place d’Arsonval
Lyon
69437
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1439

Study information

Scientific title

Acronym

Study hypothesis

Evaluation of heparin-free treatment

Ethics approval

Approved by the Committee for the Protection of Persons (CPP) on 06/12/2005, reference number 2005/063B

Study design

Pilot, prospective, multicentric, open study

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

Patients are treated with a maximum five filters.

Please note that the study period of this trial has been extended to December 2007.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Safety assessment of heparin-free treatment

Overall trial start date

30/11/2005

Overall trial end date

30/08/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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.

Recruitment start date

30/11/2005

Recruitment end date

30/08/2006

Locations

Countries of recruitment

France

Trial participating centre

Hôpital Edouard Herriot
Lyon
69437
France

Sponsor information

Organisation

Gambro Industries (France)

Sponsor details

61 Avenue Tony Garnier
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