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NCT04568694 Clinical Trial

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

Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04568694
Other study ID # 20-00339
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date December 3, 2021

Study information
Verified date July 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 3, 2021
Est. primary completion date December 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Delayed Lung Transplantation
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
Reference Therapy

Locations
Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant As defined by International Society of Heart and Lung Transplantation (ISHLT) 72 hours
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