Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient. The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Perla® must be cooled to 2° to 6 °C prior to use. The cold Preservation Solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation.
Centro Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Graft Function Rate (Kidney & Liver)
Time frame: 7 days post transplant
Graft survival (Kidney & Liver)
Time frame: 7 days post-transplant
Graft survival (Kidney & Liver)
Time frame: 14 & 30 days post-transplant
Rate of an event or serious adverse device effects (Kidney & Liver)
Time frame: within 30 days post-transplant
Evaluation of patient anxiety (Kidney & Liver)
The patient will complete the HAD scale ("Hospital Anxiety and Depression Scale") after signing his/her consent before the transplant.
Time frame: pre-transplant
Duration of delayed graft function (Kidney)
Time frame: within 30 days post-transplant
Rate of functional delayed graft function (f-DGF) (Kidney)
Time frame: within 7 days post-transplant
Daily serum creatinine (Kidney)
Time frame: 7 days post-transplant, or until the patient is discharged - whichever is earliest
Peak level of serum AST (Liver)
Time frame: within 7 days post-transplant
Post-reperfusion syndrome (Liver)
Time frame: during operative procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.