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Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879268
First Posted: April 9, 2009
Last Update Posted: April 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by:
Polyak, Maximilian
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Liver Machine Preservation With Vasosol Solution

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879268


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

Responsible Party: Dr. James V. Guarrera, Columbia University Medical Center
ClinicalTrials.gov Identifier: NCT00879268     History of Changes
Other Study ID Numbers: G030132
First Submitted: April 7, 2009
First Posted: April 9, 2009
Last Update Posted: April 9, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Pharmaceutical Solutions