PERTRIAL - Perla® Preservation Solution

Not Applicable

Completed

• Conditions: Organ Transplant; Ischemic Reperfusion Injury
• Interventions: Drug: Perla® Cold Preservation solution

• Registration Number: NCT05194306
• Lead Sponsor: Advanced Life Solutions

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-11
• Study First Submitted: 2021-12-14
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-18
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perla® Cold Preservation solution	Perla® Cold Preservation solution	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.

Primary Outcome Measures

Name	Time	Method
Graft Function Rate (Kidney & Liver)	7 days post transplant

Secondary Outcome Measures

Name	Time	Method
Post-reperfusion syndrome (Liver)	during operative procedure
Daily serum creatinine (Kidney)	7 days post-transplant, or until the patient is discharged - whichever is earliest
Duration of delayed graft function (Kidney)	within 30 days post-transplant
Peak level of serum AST (Liver)	within 7 days post-transplant
Rate of functional delayed graft function (f-DGF) (Kidney)	within 7 days post-transplant
Graft survival (Kidney & Liver)	14 & 30 days post-transplant
Evaluation of patient anxiety (Kidney & Liver)	pre-transplant	The patient will complete the HAD scale ("Hospital Anxiety and Depression Scale") after signing his/her consent before the transplant.
Rate of an event or serious adverse device effects (Kidney & Liver)	within 30 days post-transplant

Trial Locations

Locations (1)

Centro Hospitalario Universitario A Coruña (CHUAC); 🇪🇸 A Coruña, Spain