PERTRIAL - Perla® Preservation Solution

NCT05194306 | Completed

• 1 other identifier: CIP001A
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Transplant; Ischemic Reperfusion Injury

Keywords

Cold Preservation Solution; Ischemic Reperfusion Injury; Organ Transplant

Outcome Measures

Primary Outcomes (1)

• Graft Function Rate (Kidney & Liver)

  7 days post transplant

Secondary Outcomes (9)

• 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)

  pre-transplant

• Duration of delayed graft function (Kidney)

  within 30 days post-transplant

Study Arms (1)

Perla® Cold Preservation solution

EXPERIMENTAL

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

Interventions

Perla® Cold Preservation solution DRUG

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.

Perla® Cold Preservation solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Donor participating at the same time in another Clinical Investigation
• Recipient eligibility criteria:
• Patient registered primary kidney or liver transplant candidate, male or female
• Patient ages ≥ 18 years old
• Patient who has signed written informed consent
• 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

Sponsors & Collaborators

• Advanced Life Solutions: lead
• Complexo Hospitalario Universitario de A Coruña: collaborator

Study Sites (1)

Centro Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 18, 2022
• Study Start: December 11, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 17, 2023

Record last verified: 2022-01

Locations

ES (1)