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Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

This study has been completed.
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by:
Polyak, Maximilian
ClinicalTrials.gov Identifier:
NCT00879268
First received: April 7, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Liver Transplantation
Organ Preservation
 Device: Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Liver Machine Preservation With Vasosol Solution

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Polyak, Maximilian:

Enrollment: 20
Study Start Date: July 2004
Study Completion Date: February 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
    Utilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation
    Other Names:
    • Vasosol Solution
    • Medtronic Portable Bypass System
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879268

Sponsors and Collaborators
Polyak, Maximilian
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: James V. Guarrera, M.D. Columbia University
  More Information

No publications provided

Responsible Party: Dr. James V. Guarrera, Columbia University Medical Center
ClinicalTrials.gov Identifier: NCT00879268     History of Changes
Other Study ID Numbers: G030132
Study First Received: April 7, 2009
Last Updated: April 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Polyak, Maximilian:
Liver Transplantation
Organ Preservation
Liver Preservation
 Machine Perfusion
Vasosol
Machine Preservation

ClinicalTrials.gov processed this record on May 19, 2013