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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05194306
Other study ID # CIP001A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2021
Est. completion date April 30, 2022

Study information

Verified date January 2022
Source Advanced Life Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Perla® Cold Preservation solution
Perla® must be cooled to 2° to 6 °C prior to use. The cold Preservation Solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation.

Locations

Country Name City State
Spain Centro Hospitalario Universitario A Coruña (CHUAC) A Coruña

Sponsors (2)

Lead Sponsor Collaborator
Advanced Life Solutions Complexo Hospitalario Universitario de A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

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