An interventional study of Perla® Cold Preservation solution in Organ Transplant and Ischemic Reperfusion Injury, sponsored by Advanced Life Solutions. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Advanced Life Solutions · Not applicable, Interventional, and Treatment
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.
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's enrollment of 11 is below the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →This is the only study on the registry with Advanced Life Solutions as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Donor kidney / liver eligibility criteria:
Inclusion Criteria:
Exclusion Criteria:
Recipient eligibility criteria:
Inclusion Criteria:
Exclusion criteria:
Patient recipient will not be included if any of the following conditions exists:
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.
Drug: Perla® Cold Preservation solution
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.
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 study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.