Ischemic Reperfusion Injury Clinical Trial
Official title:
Evaluation of the Safety and Performance of Perla® Preservation Solution for Donor Liver and Kidney for Transplantation
Verified date | January 2022 |
Source | Advanced Life Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Centro Hospitalario Universitario A Coruña (CHUAC) | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Advanced Life Solutions | Complexo Hospitalario Universitario de A Coruña |
Spain,
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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