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PERTRIAL - Perla® Preservation Solution

Primary Purpose

Organ Transplant, Ischemic Reperfusion Injury

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Perla® Cold Preservation solution

About this trial

This is an interventional treatment trial for Organ Transplant focused on measuring Cold Preservation Solution, Ischemic Reperfusion Injury, Organ Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro Hospitalario Universitario A Coruña (CHUAC)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perla® Cold Preservation solution

Arm Description

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.

Outcomes

Primary Outcome Measures

Graft Function Rate (Kidney & Liver)

Secondary Outcome Measures

Graft survival (Kidney & Liver)

Rate of an event or serious adverse device effects (Kidney & Liver)

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.

Duration of delayed graft function (Kidney)

Rate of functional delayed graft function (f-DGF) (Kidney)

Daily serum creatinine (Kidney)

Peak level of serum AST (Liver)

Post-reperfusion syndrome (Liver)

Full Information

NCT ID

NCT05194306

First Posted

December 14, 2021

Last Updated

May 15, 2023

Sponsor

Advanced Life Solutions

Collaborators

Complexo Hospitalario Universitario de A Coruña

1. Study Identification

Unique Protocol Identification Number

NCT05194306

Brief Title

PERTRIAL - Perla® Preservation Solution

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

December 11, 2021 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanced Life Solutions

Collaborators

Complexo Hospitalario Universitario de A Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Organ Transplant, Ischemic Reperfusion Injury

Keywords

Cold Preservation Solution, Ischemic Reperfusion Injury, Organ Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Perla® Cold Preservation solution

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Perla® Cold Preservation solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Graft Function Rate (Kidney & Liver)

Time Frame

7 days post transplant

Secondary Outcome Measure Information:

Title

Graft survival (Kidney & Liver)

Time Frame

7 days post-transplant

Title

Graft survival (Kidney & Liver)

Time Frame

14 & 30 days post-transplant

Title

Rate of an event or serious adverse device effects (Kidney & Liver)

Time Frame

within 30 days post-transplant

Title

Evaluation of patient anxiety (Kidney & Liver)

Description

The patient will complete the HAD scale ("Hospital Anxiety and Depression Scale") after signing his/her consent before the transplant.

Time Frame

pre-transplant

Title

Duration of delayed graft function (Kidney)

Time Frame

within 30 days post-transplant

Title

Rate of functional delayed graft function (f-DGF) (Kidney)

Time Frame

within 7 days post-transplant

Title

Daily serum creatinine (Kidney)

Time Frame

7 days post-transplant, or until the patient is discharged - whichever is earliest

Title

Peak level of serum AST (Liver)

Time Frame

within 7 days post-transplant

Title

Post-reperfusion syndrome (Liver)

Time Frame

during operative procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Centro Hospitalario Universitario A Coruña (CHUAC)

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

12. IPD Sharing Statement

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PERTRIAL - Perla® Preservation Solution

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