Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-01-31

Brief Summary

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A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.

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Detailed Description

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Conditions

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Liver Preservation

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 Liver

OCS Liver will be used to preserve the donor liver

Group Type EXPERIMENTAL

OCS Liver

Intervention Type DEVICE

OCS Liver will be used to preserve the donor liver

Interventions

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OCS Liver

OCS Liver will be used to preserve the donor liver

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: written informed consent

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 (\>265 mmol/L) for \>2 weeks and/or requiring hemodialysis;
* Multi-organ transplant;
* Ventilator dependent;
* Dependent on \> 1 IV inotrope to maintain hemodynamics;
* Malignancy excluding HCC;
* Infection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No