Machine perfusion preservation versus cold storage of cadaveric kidneys for transplantation
| ISRCTN | ISRCTN83876362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83876362 |
| Protocol serial number | TR 811/1-1 |
| Sponsor | Organ Recovery Systems Inc. (USA) |
| Funders | Organ Recovery Systems Inc. (USA), German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) |
- Submission date
- 14/09/2005
- Registration date
- 25/01/2006
- Last edited
- 19/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rutger J Ploeg
Scientific
Scientific
University Medical Center
Deparment of Surgery
PO Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3614430 |
|---|---|
| r.j.ploeg@chir.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Machine perfusion preservation versus cold storage of cadaveric kidneys for transplantation |
| Study acronym | Machine Preservation Trial |
| Study objectives | Machine perfusion reduces the rate of delayed graft function following kidney transplantation compared to cold storage |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Kidney insufficiency |
| Intervention | One kidney of each donor is randomised to machine perfusion, the other kidney will be cold stored |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Delayed graft function defined by necessity of dialysis in the first 7 days post transplant |
| Key secondary outcome measure(s) |
1. Decrease of creatinine |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 600 |
| Key inclusion criteria | Every deceased donor older than 15 years will be included |
| Key exclusion criteria | Combined transplantations |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- Germany
- Netherlands
Study participating centre
University Medical Center
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No | |
| Results article | results | 01/06/2011 | Yes | No | |
| Results article | results | 01/08/2018 | Yes | No |
Editorial Notes
19/03/2019: Publication reference added.
