Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

Polyak, Maximilian

Status and phase: Completed; Phase 1

Conditions: Liver Transplantation; Organ Preservation

Treatments: Device: Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00879268

G030132

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)