Transplanting Lungs From Uncontrolled Donation After Circulatory Death

Transplanting Lungs From Uncontrolled Donation After Circulatory Death: An Early Phase Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Transplantation
• Intervention / Treatment: Device: Lung uDCD Protocol

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolyn Sidoti; Phone Number: 646-987-1371; Email: Carolyn.Sidoti@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung uDCD Protocol	Device: Lung uDCD Protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time from transplant to death due to any cause.	72 Hours Post-Transplant
Overall Survival	Time from transplant to death due to any cause.	1 Year Post-Transplant

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Stephen Wall, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-00009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared beginning 9 months and ending 5 years following article publication. The data will be available at a third party website. 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 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Anyone who wishes to access the data for any purpose will be able to access the data at a third party website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes