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ISRCTN
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ISRCTN83876362
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ClinicalTrials.gov identifier
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Public title
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Machine perfusion preservation versus cold storage of cadaveric kidneys for transplantation
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Scientific title
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Acronym
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Machine Preservation Trial
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Serial number at source
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TR 811/1-1
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Study hypothesis
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Machine perfusion reduces the rate of delayed graft function following kidney transplantation compared to cold storage
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany, Netherlands
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Disease/condition/study domain
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Kidney insufficiency
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Participants - inclusion criteria
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Every deceased donor older than 15 years will be included
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Participants - exclusion criteria
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Combined transplantations
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Anticipated start date
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01/11/2005
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Anticipated end date
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31/10/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300 donors, 600 recipients
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Interventions
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One kidney of each donor is randomised to machine perfusion, the other kidney will be cold stored
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Primary outcome measure(s)
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Delayed graft function defined by necessity of dialysis in the first 7 days post transplant
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Secondary outcome measure(s)
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1. Decrease of creatinine
2. Rejection rates
3. Graft survival
4. Economics
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Sources of funding
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1. Organ Recovery Systems Inc. (USA)
2. German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany)
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Trial website
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Publications
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1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19118301
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21332580
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Contact name
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Prof
Rutger J
Ploeg
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Address
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University Medical Center
Deparment of Surgery
PO Box 30001
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City/town
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Groningen
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Zip/Postcode
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9700 RB
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Country
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Netherlands
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Tel
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+31 (0)50 3614430
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Fax
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+31 (0)50 3614873
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Email
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r.j.ploeg@chir.umcg.nl
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Sponsor
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Organ Recovery Systems Inc. (USA)
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Address
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2570 East Devon avenue
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City/town
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Des Plaines
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Zip/Postcode
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IL 60018
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Country
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United States of America
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Email
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lrodgers@organ-recovery.com
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Sponsor website:
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http://www.organ-recovery.com
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Date applied
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14/09/2005
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Last edited
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06/09/2011
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Date ISRCTN assigned
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25/01/2006
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