Transplanting Lungs From Uncontrolled Donation After Circulatory Death

Status Not yet recruiting

Clinical Trial 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 operations/clinical 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lung Transplantation

Clinical Trial Details

NCT number	NCT06327945
Study type	Interventional
Source	NYU Langone Health
Contact	Carolyn Sidoti
Phone	646-987-1371
Email	Carolyn.Sidoti@nyulangone.org
Status	Not yet recruiting
Phase	N/A
Start date	July 1, 2024
Completion date	June 30, 2028

View Details

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