Condition category
Surgery
Date applied
14/09/2005
Date assigned
25/01/2006
Last edited
06/09/2011
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 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

http://www.organ-recovery.com

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

  1. 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.

  2. 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.

Additional files

Editorial Notes