Contact information
Type
Scientific
Primary contact
Prof Rutger J Ploeg
ORCID ID
Contact details
University Medical Center
Deparment of Surgery
PO Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3614430
r.j.ploeg@chir.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TR 811/1-1
Study information
Scientific title
Acronym
Machine Preservation Trial
Study hypothesis
Machine perfusion reduces the rate of delayed graft function following kidney transplantation compared to cold storage
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
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Kidney insufficiency
Intervention
One kidney of each donor is randomised to machine perfusion, the other kidney will be cold stored
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Delayed graft function defined by necessity of dialysis in the first 7 days post transplant
Secondary outcome measures
1. Decrease of creatinine
2. Rejection rates
3. Graft survival
4. Economics
Overall trial start date
01/11/2005
Overall trial end date
31/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Every deceased donor older than 15 years will be included
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
300 donors, 600 recipients
Participant exclusion criteria
Combined transplantations
Recruitment start date
01/11/2005
Recruitment end date
31/10/2006
Locations
Countries of recruitment
Germany, Netherlands
Trial participating centre
University Medical Center
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
Organ Recovery Systems Inc. (USA)
Sponsor details
2570 East Devon avenue
Des Plaines
IL 60018
United States of America
lrodgers@organ-recovery.com
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Organ Recovery Systems Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany)
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
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19118301
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21332580
Publication citations
-
Results
Treckmann J, Moers C, Smits JM, Gallinat A, Maathuis MH, van Kasterop-Kutz M, Jochmans I, Homan van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Pirenne J, Ploeg RJ, Paul A, Machine perfusion versus cold storage for preservation of kidneys from expanded criteria donors after brain death., Transpl. Int., 2011, 24, 6, 548-554, doi: 10.1111/j.1432-2277.2011.01232.x.
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Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ, Machine perfusion or cold storage in deceased-donor kidney transplantation., N. Engl. J. Med., 2009, 360, 1, 7-19, doi: 10.1056/NEJMoa0802289.