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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63852508

Enrollment

262

Registered

2014-04-09

Start date

2014-05-01

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Machine perfusion preservation techniques for ECD kidneys Surgery

Interventions

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 gr

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Graft survival after 1 year	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Belgium, Germany, Netherlands, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026