PERTRIAL - Perla® Preservation Solution

Ischemic Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194306
• Other study ID #: CIP001A
• Status: Completed
• Phase: N/A
• Start date: December 11, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2022
• Source: Advanced Life Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Reperfusion Injury
• Organ Transplant
• Reperfusion Injury

Intervention

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.

Locations

Country	Name	City	State
Spain	Centro Hospitalario Universitario A Coruña (CHUAC)	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Life Solutions	Complexo Hospitalario Universitario de A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft Function Rate (Kidney & Liver)		7 days post transplant
Secondary	Graft survival (Kidney & Liver)		7 days post-transplant
Secondary	Graft survival (Kidney & Liver)		14 & 30 days post-transplant
Secondary	Rate of an event or serious adverse device effects (Kidney & Liver)		within 30 days post-transplant
Secondary	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
Secondary	Duration of delayed graft function (Kidney)		within 30 days post-transplant
Secondary	Rate of functional delayed graft function (f-DGF) (Kidney)		within 7 days post-transplant
Secondary	Daily serum creatinine (Kidney)		7 days post-transplant, or until the patient is discharged - whichever is earliest
Secondary	Peak level of serum AST (Liver)		within 7 days post-transplant
Secondary	Post-reperfusion syndrome (Liver)		during operative procedure