Viewing Study NCT06327945



Ignite Creation Date: 2024-05-06 @ 8:17 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06327945
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-25
First Post: 2024-03-18

Brief Title: Transplanting Lungs From Uncontrolled Donation After Circulatory Death
Sponsor: NYU Langone Health
Organization: NYU Langone Health

Study Overview

Official Title: Transplanting Lungs From Uncontrolled Donation After Circulatory Death An Early Phase Clinical Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study team developed an uncontrolled donation after circulatory death uDCD protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure PEEP and supplemental oxygen The study will assess lung uDCD program safety by continuous review of operationsclinical records from each case activation and transplantation Attrition outcomes include rates of initial and continued lung preservation donation authorization lung recovery passing ex-vivo lung perfusion EVLP performance testing and lung transplantation Planned viability assessments also include macroscopic determination radiology X-ray and fiber optic bronchoscopy before initiating EVLP We expect 50 of lungs assessed with EVLP will be transplanted to meet sustainability targets Safety outcomes include the primary outcome primary graft dysfunction PGD grade III at 72 hours and secondarily survival one year after transplantation
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: True
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None