NCT02449694

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

May 11, 2015

Last Update Submit

April 4, 2018

Conditions

Liver Preservation

Outcome Measures

Primary Outcomes (2)

  • Number of donor livers preserved by OCS in a near physiologic state.

    Within 1 day of organ retrieval

  • Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted

    Within 1 day of organ retrieval

Secondary Outcomes (3)

  • Number of donor livers maintained in a metabolically active and functioning state during preservation.

    Within 1 day of organ retrieval

  • Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation.

    Within 1 day of organ retrieval

  • Frequency of liver graft-related serious adverse events

    30 days after transplantation

Study Arms (1)

OCS Liver

EXPERIMENTAL

OCS Liver will be used to preserve the donor liver

Device: OCS Liver

Interventions

OCS LiverDEVICE

OCS Liver will be used to preserve the donor liver

OCS Liver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. James's University Hospital

Leeds, West Yorkshire, LS9 7 TF, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 20, 2015

Study Start

May 1, 2016

Primary Completion

September 19, 2017

Study Completion

January 1, 2018

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

GB(1)