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Completed

NCT Number: NCT04568694

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

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.

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed Lung Transplantation

Procedure

Transplants with a planned recipient anesthesia start time between 10:00 pm and 6:00 am will be allowed to move to a start time between 6:00 am and 8:00 am at the earliest. Donor lung(s) cross clamp time must occur between 5:00 pm and 4:00 am. Lungs that meet criteria will be transported in the usual fashion in a cooler of ice at 4oC. Upon arrival to NYULH, the lungs will be transferred to cold static preservation at 10oC within a specific incubator located in a NYULH OR (MYTEMP™65HC, Benchmark Scientific).

Conventional Lung Transplantation

Procedure

Reference Therapy

Primary outcomes

  1. Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant

    Time frame: 72 hours

    As defined by International Society of Heart and Lung Transplantation (ISHLT)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-of-Concept Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2020
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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