PERTRIAL - Perla® Preservation Solution

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Safety and Performance of Perla® Preservation Solution for Donor Liver and Kidney for Transplantation

Conditions
-----------------
Organ Transplant, Ischemic Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: Perla® Cold Preservation solution


Participation Criteria
=================
Eligibility 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 Exclusion criteria: Patient recipient will not be included if any of the following conditions exists: Prior solid organ or bone marrow transplant Multi-organ transplant Contraindications to transplantation (Active infection, active malignancy, pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method) Participation in another clinical trial Patient unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perla® Cold Preservation solution<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Function Rate (Kidney & Liver) |  | 7 days post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival (Kidney & Liver) |  | 7 days post-transplant | 
| Graft survival (Kidney & Liver) |  | 14 & 30 days post-transplant | 
| Rate of an event or serious adverse device effects (Kidney & Liver) |  | 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. | pre-transplant | 
| Duration of delayed graft function (Kidney) |  | within 30 days post-transplant | 
| Rate of functional delayed graft function (f-DGF) (Kidney) |  | within 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cold Preservation Solution, Ischemic Reperfusion Injury, Organ Transplant