Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2021
CompletedJuly 22, 2022
July 1, 2022
1 year
September 25, 2020
July 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Delayed Lung Transplantation
EXPERIMENTALPatients that received lung(s) delayed for transplantation
Conventional Lung Transplantation
ACTIVE COMPARATORReference Therapy
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nader Moazami, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
September 29, 2020
Study Start
November 30, 2020
Primary Completion
December 3, 2021
Study Completion
December 3, 2021
Last Updated
July 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication
- Access Criteria
- Requests may be directed to the PI.
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.