Back to resultsPlanned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation
Primary Purpose
Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed Lung Transplantation
Conventional Lung Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Delayed Lung Transplantation
Conventional Lung Transplantation
Arm Description
Patients that received lung(s) delayed for transplantation
Reference Therapy
Outcomes
Primary Outcome Measures
Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant
As defined by International Society of Heart and Lung Transplantation (ISHLT)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04568694
Brief Title
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation
Official Title
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-of-Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delayed Lung Transplantation
Arm Type
Experimental
Arm Description
Patients that received lung(s) delayed for transplantation
Arm Title
Conventional Lung Transplantation
Arm Type
Active Comparator
Arm Description
Reference Therapy
Intervention Type
Procedure
Intervention Name(s)
Delayed Lung Transplantation
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Conventional Lung Transplantation
Intervention Description
Reference Therapy
Primary Outcome Measure Information:
Title
Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant
Description
As defined by International Society of Heart and Lung Transplantation (ISHLT)
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Moazami, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Requests may be directed to the PI.
Learn more about this trial
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation
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