PERTRIAL - Perla® Preservation Solution

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

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 Overview

• Status: Completed
• Conditions: Ischemic Reperfusion Injury; Organ Transplant
• Intervention / Treatment: Drug: Perla® Cold Preservation solution

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Centro Hospitalario Universitario A Coruña (CHUAC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perla® Cold Preservation solution; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Advanced Life Solutions
• Collaborators: Complexo Hospitalario Universitario de A Coruña

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Organ Transplant; Cold Preservation Solution; Ischemic Reperfusion Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Reperfusion Injury
• Other Study ID Numbers: CIP001A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No