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Completed

NCT Number: NCT05194306

PERTRIAL - Perla® 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.

The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution.

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Key information

Conditions

Organ Transplant Ischemic Reperfusion Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perla® Cold Preservation solution

Drug

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.

Primary outcomes

  1. Graft Function Rate (Kidney & Liver)

    Time frame: 7 days post transplant

Secondary outcomes

  1. Graft survival (Kidney & Liver)

    Time frame: 7 days post-transplant

  2. Graft survival (Kidney & Liver)

    Time frame: 14 & 30 days post-transplant

  3. Rate of an event or serious adverse device effects (Kidney & Liver)

    Time frame: within 30 days post-transplant

  4. Evaluation of patient anxiety (Kidney & Liver)

    Time frame: pre-transplant

    The patient will complete the HAD scale ("Hospital Anxiety and Depression Scale") after signing his/her consent before the transplant.

  5. Duration of delayed graft function (Kidney)

    Time frame: within 30 days post-transplant

  6. Rate of functional delayed graft function (f-DGF) (Kidney)

    Time frame: within 7 days post-transplant

  7. Daily serum creatinine (Kidney)

    Time frame: 7 days post-transplant, or until the patient is discharged - whichever is earliest

  8. Peak level of serum AST (Liver)

    Time frame: within 7 days post-transplant

  9. Post-reperfusion syndrome (Liver)

    Time frame: during operative procedure

Sponsors and collaborators

Lead sponsor

Advanced Life Solutions

Industry

Collaborators

  • Complexo Hospitalario Universitario de A Coruña

Registry information

Official study title

Evaluation of the Safety and Performance of Perla® Preservation Solution for Donor Liver and Kidney for Transplantation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2022
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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