Status:
UNKNOWN
Clinical Trial of New Hypothermic Oxygenated Perfusion System Versus Static Cold Storage
Lead Sponsor:
University of Bologna
Conditions:
Liver Diseases
Kidney Diseases
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
With the present study the investigators will evaluate the benefit of end-ischemic HOPE on ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a recently developed mach...
Detailed Description
Extended criteria donors (ECD) are widely utilized due to organ shortage, but this may increase the risk of graft dysfunction and of poorer outcomes. Hypothermic oxygenated perfusion (HOPE) is a rece...
Eligibility Criteria
Inclusion
- For kidneys: donor age ≥ 60 years or 50-59 years with two or more of the sequent risk factors: death due to cerebrovascular accident, history of hypertension, donor serum creatinine \> 1.5 mg/dL, cold ischemia time (CIT) \> 20 h;
- For livers: donors with hemodynamic deterioration, donor age \> 65 years, donor body mass index \> 30 kg/m2, serum bilirubin \> 3 mg/dl, AST or ALT above three times the upper reference threshold, sodium \> 165 mmol/l, intensive care unit (ICU) stay \> 7 days, steatosis \> 40%, CIT \> 12 h.
Exclusion
- Donor age ≤18 years;
- Donors after circulatory death (DCD) will be excluded, because Italian law requires 20 minutes of "no touch period" before death declaration, causing prolonged warm ischemia and subsequent mandatory perfusion of the organ.
- Split-liver recipients, liver transplantation (LT) for acute liver failure, pre-emptive renal transplant, dual kidney transplantation, and patients with intra-operative surgical complications before the organ implantation.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03837197
Start Date
December 21 2018
End Date
December 1 2021
Last Update
September 27 2019
Active Locations (1)
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1
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, Italy, 40138