NCT00879268

Brief Summary

This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_1

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

Study Start

First participant enrolled

July 1, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
Last Updated

April 9, 2009

Status Verified

April 1, 2009

Enrollment Period

3.6 years

First QC Date

April 7, 2009

Last Update Submit

April 7, 2009

Conditions

Liver TransplantationOrgan Preservation

Keywords

Liver TransplantationOrgan PreservationLiver PreservationMachine PerfusionVasosolMachine Preservation

Interventions

Vasosol Organ Perfusion Solution and Medtronic Portable Bypass SystemDEVICE

Utilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation

Also known as: Vasosol Solution, Medtronic Portable Bypass System

Eligibility Criteria

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

You may qualify if:

  • Primary/ Solitary Liver Transplant
  • Lab MELD\<35
  • Donor age \<65

You may not qualify if:

  • Donor Liver \> 30% Macrosteatosis
  • DCD donor liver
  • Multi-organ Recipient
  • Recipient in ICU
  • Retransplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • James V. Guarrera, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

July 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2009

Last Updated

April 9, 2009

Record last verified: 2009-04