PERTRIAL - Perla® Preservation Solution

Advanced Life Solutions

Status: Completed

Conditions: Organ Transplant; Ischemic Reperfusion Injury

Treatments: Drug: Perla® Cold Preservation solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05194306

CIP001A

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Perla® Cold Preservation solution

Experimental group

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.

Treatment:

Drug: Perla® Cold Preservation solution