OCS Liver DCD Trial

NCT ID: NCT04194437

Last Updated: 2025-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-24

Study Completion Date

2024-12-16

Brief Summary

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Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Detailed Description

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To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Conditions

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Liver Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OCS Preserved Livers

This is a single-arm trial of OCS preserved livers used for transplantation.

Group Type EXPERIMENTAL

OCS Liver System

Intervention Type DEVICE

The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.

Interventions

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OCS Liver System

The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Registered primary liver transplant candidate
* Age ≥ 18 years
* Obtained informed consent

Exclusion Criteria

* Acute, fulminant liver failure
* Prior solid organ or bone marrow transplant
* Ventilator dependent on day of transplant/donor organ offer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TransMedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Elbetanony, MD

Role: STUDY_DIRECTOR

TransMedics

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

University of Texas San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.

Reference Type DERIVED
PMID: 33650998 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OCS-LVR-092019

Identifier Type: -

Identifier Source: org_study_id

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