Cold Pulsatile Perfusion in Asystolic donor Renal Transplantation

ISRCTN	ISRCTN95022818
DOI	https://doi.org/10.1186/ISRCTN95022818
Protocol serial number	N/A
Sponsor	Addenbrooke's Hospital (UK)
Funder	Addenbrooke's Hospital (UK) - transplant research fund

Submission date: 31/03/2005
Registration date: 10/05/2005
Last edited: 04/02/2016

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

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

Contact information

Mr Christopher Watson
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A multicentre randomised controlled study of cold Pulsatile Perfusion in Asystolic donor Renal Transplantation
Study acronym	PPART
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	Kidney preservation prior to transplantation
Intervention	Machine perfusion of the kidney before transplantation versus simple cold storage
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	28/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	205
Key inclusion criteria	Subjects (aged 18 years and over, either gender) undergoing transplantation of a kidney from a non-heart-beating (asystolic) cadaver organ donor.
Key exclusion criteria	Added 24/02/2009: 1. Lack of informed consent 2. Positive cross-match 3. Previous recipient of non-renal transplant
Date of first enrolment	18/08/2006
Date of final enrolment	28/02/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 2QQ
United Kingdom

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	01/09/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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