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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014