PERTRIAL - Perla® Preservation Solution

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advanced Life Solutions
• Collaborator: Centro Hospitalario Universitario A Coruña

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