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Summary

for people ages 18–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Official Title

International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)

Details

The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics:

  • Donor PaO2/FiO2 ≤ 300 mmHg; or
  • Expected ischemic time > 6 hours; or
  • Donor after Cardiac Death (DCD donor); or
  • Donor age ≥55 years old

Keywords

Lung Transplant lung transplantation lung preservation breathing lung transplant

Eligibility

You can join if…

Open to people ages 18–75

  • At least one of the following:
  • Donor PaO2/FiO2 ≤ 300 mmHg; or
  • Expected ischemic time > 6 hours; or
  • Donor after Cardiac Death (DCD donor); or
  • Donor age ≥55 years old

You CAN'T join if...

  • • Presence of moderate to severe traumatic lung injury with air and/or blood leak
  • Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction
  • Previous history of pulmonary disease
  • Multiple transfusions of >10 pRBCs units
  • ABO incompatibility
  • Tobacco history of >20 pack years

Locations

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • University of California at Los Angeles accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT01963780
Phase
Phase 3
Lead Scientist
Jasleen Kukreja
Study Type
Interventional
Last Updated
March 2016
I’m interested in this study!