Status:
COMPLETED
PERTRIAL - Perla® Preservation Solution
Lead Sponsor:
Advanced Life Solutions
Collaborating Sponsors:
Complexo Hospitalario Universitario de A Coruña
Conditions:
Organ Transplant
Ischemic Reperfusion Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Donor kidney / liver eligibility 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
- 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
Key Trial Info
Start Date :
December 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05194306
Start Date
December 11 2021
End Date
April 30 2022
Last Update
May 17 2023
Active Locations (1)
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1
Centro Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain, 15006