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

Not Applicable
Completed
Conditions
Pulmonary Disease
Registration Number
NCT04568694
Lead Sponsor
NYU Langone Health
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1
Inclusion Criteria
  • Recipient is β‰₯ 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant72 hours

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

NYU Langone Health

πŸ‡ΊπŸ‡Έ

New York, New York, United States

NYU Langone Health
πŸ‡ΊπŸ‡ΈNew York, New York, United States

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