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.
| ISRCTN | ISRCTN02674550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02674550 |
| Secondary identifying numbers | 1439 |
- Submission date
- 02/02/2006
- Registration date
- 28/02/2006
- Last edited
- 22/12/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Bernard Allaouchiche
Scientific
Scientific
Hôpital Edouard Herriot
Service dAnesthésie-Réanimation
Pavillon G
5 Place dArsonval
Lyon
69437
France
Study information
| Study design | Pilot, prospective, multicentric, open study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Evaluation of heparin-free treatment |
| Ethics approval(s) | Approved by the Committee for the Protection of Persons (CPP) on 06/12/2005, reference number 2005/063B |
| 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 |
| Primary outcome measure | 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 study start date | 30/11/2005 |
| Overall study end date | 30/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| 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 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
Study participating centre
Hôpital Edouard Herriot
Lyon
69437
France
69437
France
Sponsor information
Gambro Industries (France)
Industry
Industry
61 Avenue Tony Garnier
Lyon
69357
France
"ROR" |
https://ror.org/01mgtdr23 |
|---|
Funders
Funder type
Industry
Gambro Industries
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
