An interventional study of HOPE and Conventional cold storage in Reperfusion Injury and Hypothermic Oxygenated Machine Perfusion, sponsored by University Hospital, Aachen. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by University Hospital, Aachen · Not applicable, Interventional, and Treatment
Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in pre-clinical experiments and in a few clinical series of donation after cardiac death (DCD) in liver transplantation. The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before implantation and are going to be compared to a case matched group transplanted after conventional cold storage (CCS).
The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of HOPE via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS. Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted biomarker analysis is planned using tissue, serum, and urine samples as the translational and basic research aspect of the present study.
260 studies on the registry are indexed under Reperfusion Injury; 43 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 212 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →University Hospital, Aachen is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. is obtained from all subjects participating in the trial by a qualified member of the study team.
ECD is defined as followed: deceased donors > 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group)
Other: Conventional cold storage
HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)
Procedure: HOPE
HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)
No intervention
DGF
DGF (defined as the need for dialysis in the first 7-days post-transplantation)
Time frame: 7 days post-transplant
CRR2, CRR5
Creatinine reduction ratio day 2 (CRR2= creatinine day 1-creatinine day 2/creatinine day 1) and CRR5 (CRR5=pre-transplant creatinine-creatinine day 5/pre-transplant creatinine)
Time frame: 5 days post-transplant
postoperative complications
Clavien-Dindo complication score
Time frame: Subjects will be followed 6 months postoperatively
Cumulative postoperative complications
Comprehensive complication index (CCI)
Time frame: Subjects will be followed 6 months postoperatively
Duration of intensive care stay
Duration of ICU stay
Time frame: Subjects will be followed 6 months postoperatively
Duration of hospital stay
Duration of hospitalisation
Time frame: Subjects will be followed 6 months postoperatively
Graft survival
Six months graft survival
Time frame: Subjects will be followed 6 months postoperatively
Renal function
Renal function (serum creatinine and estimated glomerular filtration rate (eGFR))
Time frame: Subjects will be followed 6 months postoperatively
Perfusion Parameter
Flow and thus renal resistance
Time frame: During HOPE
Plan to share: Undecided
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Aachen