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Completed

NCT Number: NCT02522871

OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation

A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

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Key information

Conditions

Liver Transplantation Liver Preservation for Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego, La Jolla, California, United States

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About this study

The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Registered male or female primary Liver transplant candidate
  • Age ≥18 years old
  • Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion criteria

  • Acute, fulminant liver failure
  • Prior solid organ or bone marrow transplant
  • Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl for >2 weeks and/or requiring hemodialysis
  • Multi-organ transplant
  • Ventilator dependent
  • Dependent on > 1 IV inotrope to maintain hemodynamics

Treatment and study plan

OCS™ Liver System

Device

Control

Other

Primary outcomes

  1. Participants With Early Liver Allograft Dysfunction (EAD)

    Time frame: 7 days

    Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level > 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)

  2. Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient

    Time frame: 30 days

    Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.

Secondary outcomes

  1. Patient Survival at Day 30 After Transplant

    Time frame: 30 days after transplant

    Patient survival at day 30 after transplantation

  2. Patient Survival at Initial Hospital Discharge Post Liver Transplant

    Time frame: at initial hospital discharge post liver transplant, an average of 11 days

    Patient survival at initial hospital discharge post liver transplantation

Other outcomes

  1. Evidence of Ischemic Biliary Complications Diagnosed at 6 Months

    Time frame: 6 months post transplant

    Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 6 Months Follow-up Visit

  2. Evidence of Ischemic Biliary Complications Diagnosed at 12 Months

    Time frame: 12 months post transplant

    Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 12 Months Follow-up Visit

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)

Acronym: PROTECT

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Aug 13, 2015
Registry last updated
Jun 29, 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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