Ischemic Reperfusion Injury, Organ Transplant
Conditions
Keywords
Cold Preservation Solution, Ischemic Reperfusion Injury, Organ Transplant
Brief summary
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.
Interventions
DRUGPerla® 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.
Sponsors
Complexo Hospitalario Universitario de A Coruña
Advanced Life Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Donor kidney / liver eligibility criteria: Inclusion Criteria: * Donor kidney / liver suitable for preservation * Donor age equal or over 18 years old * Donor meets one of the following conditions: * Donor after brain death (DBD), standard and extended criteria (SCD & ECD) * Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
Exclusion criteria
* Donor participating at the same time in another Clinical Investigation Recipient eligibility criteria: Inclusion Criteria: * Patient registered primary kidney or liver transplant candidate, male or female * Patient ages ≥ 18 years old * Patient who has signed written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft Function Rate (Kidney & Liver) | 7 days post transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of an event or serious adverse device effects (Kidney & Liver) | within 30 days post-transplant | — |
| Evaluation of patient anxiety (Kidney & Liver) | pre-transplant | The patient will complete the HAD scale (Hospital Anxiety and Depression Scale) after signing his/her consent before the transplant. |
| Duration of delayed graft function (Kidney) | within 30 days post-transplant | — |
| Graft survival (Kidney & Liver) | 7 days post-transplant | — |
| Daily serum creatinine (Kidney) | 7 days post-transplant, or until the patient is discharged - whichever is earliest | — |
| Peak level of serum AST (Liver) | within 7 days post-transplant | — |
| Post-reperfusion syndrome (Liver) | during operative procedure | — |
| Rate of functional delayed graft function (f-DGF) (Kidney) | within 7 days post-transplant | — |
Countries
Spain
Outcome results
None listed