Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

Liver Transplantation Clinical Trial

Official title:

Phase 1 Study of Liver Machine Preservation With Vasosol Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879268
• Other study ID #: G030132
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2009
• Last updated: April 7, 2009
• Start date: July 2004
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: Polyak, Maximilian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation
• Organ Preservation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Polyak, Maximilian	Health Resources and Services Administration (HRSA)