Transplanting Lungs From Uncontrolled Donation After Circulatory Death

NCT06327945 | Recruiting DMC FDA Device

• 1 other identifier: 22-00009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of Primary Graft Dysfunction (PDG) Grade III

  PGD is measured 72 hours after transplantation and defined according to the International Society for Heart and Lung Transplantation (ISHLT) criteria: partial pressure of arterial oxygen divided by the fraction of inspired oxygen (Pa02/FI02) \< 200 mm Hg.

  72 Hours Post-Transplant

Secondary Outcomes (5)

• Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)

  72 Hours Post-Transplant

• Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)

  1 Year Post-Transplant

• Incidence of Re-Transplantation

  1 Year Post-Transplant

• Overall Survival

  72 Hours Post-Transplant

• Overall Survival

  1 Year Post-Transplant

Study Arms (1)

Lung uDCD Protocol

EXPERIMENTAL

Device: Lung uDCD Protocol

Interventions

Lung uDCD Protocol DEVICE

The intervention is initiation of PEEP and supplemental oxygen, without requiring prior permission (e.g., for cases not having first person authorization for organ donation and organ donation for research), to offer lung donation opportunities for cases which would otherwise be ineligible in the U.S.

Lung uDCD Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients waiting for lung transplants
• Willing to participate in the research study

You may not qualify if:

• Unable to be followed for 1 year after transplantation
• Unable to provide written informed consent to participate in the research (or designate a surrogate)

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Stephen Wall, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Sidoti

CONTACT

646-987-1371; Carolyn.Sidoti@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: January 24, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Anyone who wishes to access the data for any purpose will be able to access the data at a third party website.

Locations

US (1)