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Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

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ClinicalTrials.gov Identifier: NCT00879268
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : April 9, 2009
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by:
Polyak, Maximilian

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

Study Type : Interventional  (Clinical Trial)
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 : July 2004
Primary Completion Date : February 2008
Study Completion Date : February 2009

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



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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

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

Responsible Party: Dr. James V. Guarrera, Columbia University Medical Center
ClinicalTrials.gov Identifier: NCT00879268     History of Changes
Other Study ID Numbers: G030132
First Posted: April 9, 2009    Key Record Dates
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