Clinical trial NCT05194306: 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
Overall status: COMPLETED
Phase: NA
Conditions: Organ Transplant
Ischemic Reperfusion Injury
Keywords: Cold Preservation Solution
Ischemic Reperfusion Injury
Organ Transplant
Lead sponsor: Advanced Life Solutions
Sponsor class: INDUSTRY
Collaborators: name: Complexo Hospitalario Universitario de A Coruña
First posted: 2022-01-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Graft Function Rate (Kidney & Liver)
timeFrame: 7 days post transplant
Secondary outcomes:
measure: Graft survival (Kidney & Liver)
timeFrame: 7 days post-transplant
measure: Graft survival (Kidney & Liver)
timeFrame: 14 & 30 days post-transplant
measure: Rate of an event or serious adverse device effects (Kidney & Liver)
timeFrame: within 30 days post-transplant
measure: Evaluation of patient anxiety (Kidney & Liver)
timeFrame: pre-transplant
measure: Duration of delayed graft function (Kidney)
timeFrame: within 30 days post-transplant
measure: Rate of functional delayed graft function (f-DGF) (Kidney)
timeFrame: within 7 days post-transplant
measure: Daily serum creatinine (Kidney)
timeFrame: 7 days post-transplant, or until the patient is discharged - whichever is earliest
measure: Peak level of serum AST (Liver)
timeFrame: within 7 days post-transplant
measure: Post-reperfusion syndrome (Liver)
timeFrame: during operative procedure
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Centro Hospitalario Universitario A Coruña (CHUAC)
Study officials:
References: