Cold Pulsatile Perfusion in Asystolic donor Renal Transplantation
| ISRCTN | ISRCTN95022818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95022818 |
| Secondary identifying numbers | N/A |
- 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
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
Contact information
Scientific
Department of Surgery
Box 202
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | A multicentre randomised controlled study of cold Pulsatile Perfusion in Asystolic donor Renal Transplantation |
| Study 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(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. |
| Condition | Kidney preservation prior to transplantation |
| Intervention | Machine perfusion of the kidney before transplantation versus simple cold storage |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 18/08/2006 |
| Overall study end date | 28/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 205 |
| 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 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
- England
- United Kingdom
Study participating centre
CB2 2QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html |
|---|---|
"ROR" |
https://ror.org/055vbxf86 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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
