International EXPAND Lung Pivotal Trial (EXPANDLung)

TransMedics

Status: Completed

Conditions: Lung Transplant

Treatments: Device: OCS Lung Preservation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01963780

OCS-LUN-012013

Details and patient eligibility

About

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.

Full description

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

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• • 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

OCS Lung Tx.

Experimental group

Description:

A prospective, pivotal single arm trial.

Treatment:

Device: OCS Lung Preservation