Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation

NYU Langone Health

Status: Completed

Conditions: Pulmonary Disease

Treatments: Procedure: Delayed Lung Transplantation; Procedure: Conventional Lung Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04568694

20-00339

Details and patient eligibility

About

This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient is ≥ 18 years old
• Recipient, or their Legally Authorized Representative is able and willing to sign informed consent
• Recipient meets standard listing criteria for lung transplantation

Exclusion criteria

• Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP)
• Recipient is < 18 years old
• Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation
• Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Delayed Lung Transplantation

Experimental group

Description:

Patients that received lung(s) delayed for transplantation

Treatment:

Procedure: Delayed Lung Transplantation

Conventional Lung Transplantation

Active Comparator group

Description:

Reference Therapy

Treatment:

Procedure: Conventional Lung Transplantation