Condition category
Surgery
Date applied
31/03/2005
Date assigned
10/05/2005
Last edited
04/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kidneys from deceased organ donors need to be preserved out of the body to allow time for them to be allocated to a recipient, transported to the recipient centre, and for the recipient to be brought in and prepared for surgery. Typically this takes 12 to 18 hours. Traditionally preservation has been achieved by simply flushing the kidneys with a special preservation solution and placing them in a container of ice. An alternative is to put the kidney on a machine to continuously flush preservation fluid through the kidney until it is time to transplant the kidney into a recipient. The aim of this study is to see which method is superior for kidneys donated by deceased organ donors after circulatory death (DCD).

Who can participate?
Patients aged 18 and over undergoing transplantation of a kidney from a deceased organ donor.

What does the study involve?
Donated kidneys are randomly allocated such that one kidney of a pair is placed on the perfusion machine while the other is flushed and stored in ice until transplantation. Both kidneys of a pair are transplanted at the same centre. The transplant recipients are then followed up to see whether the kidney worked immediately or whether there was a delay in it starting normal function – around half of kidneys from DCD donors do not work immediately and the recipient needs to continue on dialysis until it does work.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Addenbrooke's Hospital (UK)

When is the study starting and how long is it expected to run for?
August 2006 to February 2009

Who is funding the study?
Novartis Pharmaceuticals and Organ Recovery Systems

Who is the main contact?
Mr Christopher Watson

Trial website

Contact information

Type

Scientific

Primary contact

Mr Christopher Watson

ORCID ID

Contact details

Department of Surgery
Box 202
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A multicentre randomised controlled study of cold Pulsatile Perfusion in Asystolic donor Renal Transplantation

Acronym

PPART

Study hypothesis

Primary objective:
To evaluate the effect of machine perfusion on the incidence of primary function post renal transplantation.

Secondary objective:
To evaluate the cost effectiveness of machine perfusion in asystolic donor kidney transplantation.

Ethics approval

The London Research Ethics Committee (REC), 02/02/2006, ref: 05/MRE02/74). Last ethics progress report dated 05/03/2008: favourable ethical opinion given 19/03/2008.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Kidney preservation prior to transplantation

Intervention

Machine perfusion of the kidney before transplantation versus simple cold storage

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Incidence of delayed graft function (need for dialysis in the first 7 days)
2. Calculated glomerular filtration rate (GFR) (MDRD technique) at 7 days

Secondary outcome measures

1. Patient survival
2. Graft survival
3. Renal function measured using calculated GFR
4. Never function rate
5. Time to last dialysis post transplant
6. Acute rejection incidence
7. Cost comparison at one and five years

Overall trial start date

18/08/2006

Overall trial end date

28/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects (aged 18 years and over, either gender) undergoing transplantation of a kidney from a non-heart-beating (asystolic) cadaver organ donor.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

205

Participant exclusion criteria

Added 24/02/2009:
1. Lack of informed consent
2. Positive cross-match
3. Previous recipient of non-renal transplant

Recruitment start date

18/08/2006

Recruitment end date

28/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Addenbrooke's Hospital (UK)

Sponsor details

Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Hospital/treatment centre

Funder name

Addenbrooke's Hospital (UK) - transplant research fund

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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20883534

Publication citations

  1. Results

    Watson CJ, Wells AC, Roberts RJ, Akoh JA, Friend PJ, Akyol M, Calder FR, Allen JE, Jones MN, Collett D, Bradley JA, Cold machine perfusion versus static cold storage of kidneys donated after cardiac death: a UK multicenter randomized controlled trial., Am. J. Transplant., 2010, 10, 9, 1991-1999, doi: 10.1111/j.1600-6143.2010.03165.x.

Additional files

Editorial Notes

04/02/2016: Publication reference added. On 24/02/2009 this record has been amended to include new start and end dates; the initial information at time of registration was as follows: Initial overall trial start date: 01/10/2005 Initial overall trial end date: 31/10/2013