COPE-POMP: 'in house' pre-implantation oxygenated hypothermic machine perfusion reconditioning after cold storage versus cold storage alone in expanded criteria donor (ECD) kidneys from brain dead donors
| ISRCTN | ISRCTN63852508 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63852508 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/02/2014
- Registration date
- 09/04/2014
- Last edited
- 22/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Kidney transplantation is a successful treatment for end-stage renal disease. The standard methods for storing and transporting kidneys for transplantation are to either store them in cold storage solution or to perfuse them with a cold perfusion solution on ice. It has been shown that machine perfusion preservation improves short term graft function, especially in kidneys donated by expanded criteria donors (ECD). Experimental models have shown that it is sufficient to perform machine perfusion immediately prior to implantation and reperfusion of the organ. This would also show a benefit to logistics, as kidneys would only need to be perfused at the transplantation center of the recipient. The aim of this study is to assess whether machine perfusion only immediately prior to implantation and after transport in cold storage solution will reduce damage, decrease ischemia-reperfusion injury and improve graft survival and function in ECD kidneys.
Who can participate?
Kidneys donated after brain death from donors fulfilling the United Network for Organ Sharing (UNOS) ECD criteria.
What does the study involve?
Two groups will be compared: a control group (static cold storage) and an interventional group (hypothermic oxygenated machine perfusion after static cold storage).
What are the possible benefits and risks of participating?
Short-term hypothermic oxygenated machine perfusion may be beneficial to static cold storage in ECD kidneys. In this study, two standard preservation methods are being compared.
Where is the study run from?
The trial will be carried out in academic hospitals with an active adult kidney transplant programme in Germany, Belgium, the Netherlands, United Kingdom and their donor hospitals. The lead center will be the University Hospital Essen, Germany.
When is the study starting and how long is it expected to run for?
December 2013 to July 2019
Who is funding the study?
European Union
Who is the main contact?
Professor Andreas Paul
Contact information
Scientific
Department of General, Visceral and Transplant Surgery
University Hospital Essen
Hufelandstr. 55
Essen
45147
Germany
Study information
| Study design | Prospective randomized parallel group patient-blinded controlled multi-center non-paired superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://cope-eu.org/ |
| Scientific title | A prospective, randomized, parallel group, single blinded, controlled, multi-center, non-paired superiority trial to compare the effect of short-term 'in house' oxygenated hypothermic machine perfusion preservation after static cold storage to static cold storage alone in transplantation of expanded criteria donor (ECD) kidneys donated after brain death |
| Study acronym | COPE-POMP (Consortium for Organ Preservation in Europe - Pre-implantation Oxygenated hypothermic Machine Perfusion) |
| Study hypothesis | Short-term reconditioning using hypothermic oxygenated machine perfusion preservation following static cold storage and prior to reimplantation is superior to static cold storage alone in ECD kidneys. |
| Ethics approval(s) | Ethics Board of the Faculty of Medicine, University of Duisburg-Essen, 25/09/2014, ref: 14-5783-BO |
| Condition | Machine perfusion preservation techniques for ECD kidneys |
| Intervention | ECD kidneys will be randomized to be preserved using either static cold storage alone or static cold storage followed by hypothermic oxygenated machine perfusion. Group 1 - control group: the kidney wil be retrieved and stored in cold storage solution until back-table preparation and kidney transplantation are performed. Group 2 - experimental group: the kidney will be placed in cold storage solution until arrival at the recipient's transplant center. Following back-table preparation the kidney will be placed on the Kidney Assist device to be perfused with cold oxygenated Belzer's Machine preservation solution until immediately before implantation. The previous sponsor for this trial (up to 24/04/2014) was: University Hospital Essen (Germany) Hufelandstr. 55 Essen 45147 Germany http://uk-essen.de/ |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Graft survival after 1 year |
| Secondary outcome measures | 1. Patient and graft survival at day 7, and at 3, 6 and 12 months after transplantation 2. Estimated glomerular filtration rate (eGFR) defined by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation at days 7 and 14 and 3, 6 and 12 months after transplantation 3. Delayed graft function (DGF), defined as the need for dialysis within the first 7 days after transplantation and preceding the return of kidney function 4. Slow graft function (SGF) based on functional DGF (fDGF), defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation 5. Primary non-function (PNF), defined as the continued need for dialysis at 3 months after transplantation 6. Biopsy proven acute rejection incidence 7. Quality of life measures (EQ-5D-5L) at time of consent, 3 and 12 months 8. Health economic analysis: length of hospital stay, intensive care unit stay, requirement of dialysis 9. Incidence of hyperkalemia at 3, 6 and 12 months 10. Incidence of calcineurin inhibitor toxicity |
| Overall study start date | 01/12/2013 |
| Overall study end date | 01/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 262 |
| Total final enrolment | 262 |
| Participant inclusion criteria | Donors: 1. Kidneys from brain dead donors fulfilling the United Network for Organ Sharing ECD criteria Recipient: 1. At least 18 years old. 2. Listed for renal transplantation due to end stage renal disease within one of the participating centers 3. The transplantation is the participant's first or re-transplantation |
| Participant exclusion criteria | Donor: 1. Kidney used for a multi-organ transplantation 2. Donor aged 85 or older 3. Donation after cardiac death 4. Kidney used for double-kidney transplantation within the same recipient Recipient: 1. Simultaneous participation in another perfusion trial 2. Scheduled to undergo multi-organ transplantation 3. Planned dual-kidney transplantation 4. Both kidneys being transplanted within the same recipient 5. Is unable or unwilling to provide informed consent |
| Recruitment start date | 01/05/2014 |
| Recruitment end date | 18/05/2018 |
Locations
Countries of recruitment
- Belgium
- England
- Germany
- Netherlands
- United Kingdom
Study participating centres
Hufelandstr. 55
Essen
45147
Germany
The Churchill Hospital
Oxford
OX3 7LJ
United Kingdom
Herestraat 49
Leuven
3000
Belgium
Rijksuniversiteit Groningen
9713 Oosterparkwijk
Groningen
9713
Netherlands
Sponsor information
University/education
c/o Ms Heather House
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
United Kingdom
| Website | http://www.nds.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/11/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in high-Impact peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 22/04/2021 | Yes | No |
Editorial Notes
22/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
09/07/2018: The recruitment end date was changed from 01/07/2018 to 18/05/2018.
24/01/2018: The overall trial end date was changed from 31/12/2018 to 01/07/2019 and the intention to publish date was changed from 31/12/2018 to 01/11/2019.
22/01/2018: The recruitment end date was changed from 31/12/2017 to 01/07/2018.
15/12/2016: The overall trial start date has been updated from 01/05/2014 to 01/12/2013. In addition, the 3 additional trial participating centres, publication and dissemination plan , IPD sharing plan and link to the participant information sheet have been added.
09/12/2016: The overall trial end date has been updated from 31/10/2016 to 31/12/2016 and the recruitment end date has been updated from 31/10/2016 to 31/12/2017.
30/03/2016: Ethics approval information added.
