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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
April 7, 2009
April 9, 2009
April 9, 2009
July 2004
February 2008   (Final data collection date for primary outcome measure)
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No Changes Posted
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Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
Phase 1 Study of Liver Machine Preservation With Vasosol Solution
This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Transplantation
  • Organ Preservation
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
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2009
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00879268
G030132
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Dr. James V. Guarrera, Columbia University Medical Center
Polyak, Maximilian
Health Resources and Services Administration (HRSA)
Principal Investigator: James V. Guarrera, M.D. Columbia University
Polyak, Maximilian
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP