International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation (INSPIRE)

TransMedics

Status: Completed

Conditions: Lung Preservation

Treatments: Device: OCS Lung; Device: Cold flush and storage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01630434

OCS-LUN-03-2010

Details and patient eligibility

About

A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Registered primary double-lung transplant candidate
• Age > or equal to 18
• Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion criteria

• Prior solid organ or bone marrow transplant
• Single lung recipient
• Multiple organ transplant recipient
• Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

OCS Lung (Treatment Group)

Experimental group

Description:

The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.

Treatment:

Device: OCS Lung

Cold flush and storage (Control Group)

Active Comparator group

Description:

Donor lungs will be preserved using cold flush and storage (control group)

Treatment:

Device: Cold flush and storage