Clincosm LogoSign in Get a demo

Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

Sponsor
Polyak, Maximilian (Other)
Overall Status
Completed
CT.gov ID
NCT00879268
Collaborator
Health Resources and Services Administration (HRSA) (U.S. Fed)
20
Enrollment
55.1
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Study of Liver Machine Preservation With Vasosol Solution
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Feb 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Primary/ Solitary Liver Transplant

    • Lab MELD<35

    • Donor age <65

    Exclusion Criteria:

    • Donor Liver > 30% Macrosteatosis

    • DCD donor liver

    • Multi-organ Recipient

    • Recipient in ICU

    • Retransplant

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Polyak, Maximilian
    • Health Resources and Services Administration (HRSA)

    Investigators

    • Principal Investigator: James V. Guarrera, M.D., Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00879268
    Other Study ID Numbers:
    • G030132
    First Posted:
    Apr 9, 2009
    Last Update Posted:
    Apr 9, 2009
    Last Verified:
    Apr 1, 2009
    Keywords provided by , ,
    Liver Transplantation
    Organ Preservation
    Liver Preservation
    Machine Perfusion
    Vasosol
    Machine Preservation
    Additional relevant MeSH terms:
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Apr 9, 2009