Cold oxygenated machine preservation of aged renal donation after cardiovascular death transplants
| ISRCTN | ISRCTN32967929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32967929 |
| Secondary identifying numbers | s55952 |
- Submission date
- 24/10/2013
- Registration date
- 11/12/2013
- Last edited
- 23/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Kidney transplantation is a successful treatment for end-stage renal disease. The standard method of storing and transporting a kidney for transplantation is to perfuse with a cold perfusion solution and store the kidney in an ice box. It has already been shown that machine perfusion preservation improves short term graft function. The aim of this study is to assess whether adding oxygen during the hypothermic machine perfusion (HMP) will reduce damages, decrease ischaemia-reperfusion injury and improve graft function.
Who can participate?
Kidneys donated after circulatory death from donors who are 50 years old or older transplanted into 2 different recipients.
What does the study involve?
Two groups will be compared: a control group (hypothermic machine perfusion with no addition of oxygen) and an intervention group (hypothermic machine perfusion with added oxygen).
What are the possible benefits and risks of participating?
It has been shown that machine perfusion preservation improves short term graft function. The addition of oxygen during hypothermic machine perfusion may be beneficial and may improve graft function.
Where is the study run from?
The trial will be carried out in academic hospitals with an active adult kidney transplant programme in Belgium, the Netherlands and the Southern region of the United Kingdom and their donor hospitals. The lead centre will be University Hospitals Leuven, Belgium.
When is the study starting and how long is it expected to run for?
February 2015 to June 2018
Who is the main contact?
1. Dr Jacques Pirenne (scientific)
jacques.pirenne@uzleuven.be
2. Professor Ina Jochmans (scientific)
ina.jochmans@uzleuven.be
Contact information
Scientific
Abdominal Transplant Surgery
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium
| Phone | +32 16 34 87 27 |
|---|---|
| jacques.pirenne@uzleuven.be |
Scientific
Abdominal Transplant Surgery
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium
| Phone | +32 16 34 87 27 |
|---|---|
| ina.jochmans@uzleuven.be |
Study information
| Study design | Randomised controlled surgeon, patient and treating physician blinded multicentre superiority trial with two parallel groups |
|---|---|
| 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 the contact details below to request a patient information sheet |
| Scientific title | A multicentre, double blind, randomised, parallel-group, paired trial to compare the effect of hypothermic machine perfusion preservation with and without the addition of oxygen in transplantation of Maastricht category III kidneys donated after circulatory death from donors aged 50 years or older |
| Study acronym | COPE-COMPARE |
| Study objectives | Oxygenated hypothermic machine perfusion (HMP) is superior for storage of kidneys of donation after cardiovascular death (DCD) category III donors than non-oxygenated (HMP). |
| Ethics approval(s) | Commissie Medische Ethiek UZ Leuven, September 2014, ref: ML10722 |
| Health condition(s) or problem(s) studied | Machine perfusion preservation techniques of kidney grafts |
| Intervention | Hypothermic machine perfusion (HMP) with and without the addition of oxygen. Group 1 control group: the kidney will be placed on the Kidney Assist HMP device and perfused with Belzers Machine Preservation Solution at a pulsatile pressure of 25 mmHg starting immediately after retrieval until back-table preparation immediately before kidney transplantation. Group 2 intervention group: the kidney will be placed on the Kidney Assist HMP device and perfused with oxygenated Belzers Machine Preservation Solution at a pulsatile pressure of 25 mmHg starting immediately after retrieval until back-table preparation immediately before kidney transplantation. |
| Intervention type | Other |
| Primary outcome measure | Kidney graft function as measured by a 24-hour creatinine clearance at 1 year after transplantation |
| Secondary outcome measures | 1. Delayed graft function (DGF) - DGF defined as the need for dialysis (excluding one time dialysis for hyperkalaemia or fluid overload) within the first 7 days after kidney transplantation and preceding the return of kidney function. Functional DGF 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 week after transplantation, not including patients in whom acute rejection or calcineurin inhibitor toxicity is proven on biopsy. 2. Primary non function (PNF) defined as the permanent lack of function of the graft from time of transplantation until months post-transplant. This endpoint is determined post-hoc at 3 months post-transplant. 3. Biopsy proven acute rejection within first year post transplant. 4. Length of recipient hospital stay 5. Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease (MDRD) equation at 3 months, 6 months and 1 year after transplantation 6. 1 year graft (censored and uncensored for recipient death) survival 7. 1 year patient survival |
| Overall study start date | 22/02/2015 |
| Completion date | 30/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 162 donors |
| Total final enrolment | 197 |
| Key inclusion criteria | Donors: 1. All potential consecutive Maastricht category III DCD donors aged 50 years or older from the collaborating donor regions Recipient: 1. At least 18 years old 2. Listed for renal transplantation due to end stage renal disease 3. Willingness to comply with the protocol procedures for the duration of the study |
| Key exclusion criteria | Donor: 1. An aortic patch too small for a reliable connection 2. Too many renal arteries preventing a safe connection Recipient: 1. Multi-organ transplantation 2. Planned dual kidney transplantation 3. The recipient is unable or unwilling to give informed consent |
| Date of first enrolment | 22/02/2015 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- Belgium
- Netherlands
- United Kingdom
Study participating centre
3000
Belgium
Sponsor information
University/education
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
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 | 21/11/2020 | 23/11/2020 | Yes | No |
Editorial Notes
23/11/2020: Publication reference and total final enrolment number added.
11/02/2016: The study contact Professor Ina Jochmans has been added.
10/12/2015: The following changes were made to the trial record:
1. The acronym was changed from COMPARDT to COPE-COMPARE.
2. The overall trial start date was changed from 01/01/2014 to 22/02/2015.
3. The overall trial end date was changed from 30/06/2017 to 30/06/2018.
4. The sponsor was changed from University Hospitals Leuven to University of Oxford.
