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NCT Number: NCT06327945

Transplanting Lungs From Uncontrolled Donation After Circulatory Death

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Primary Graft Dysfunction (PDG) Grade III

    Time frame: 72 Hours Post-Transplant

    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.

Secondary outcomes

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

    Time frame: 72 Hours Post-Transplant

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

    Time frame: 1 Year Post-Transplant

  3. Incidence of Re-Transplantation

    Time frame: 1 Year Post-Transplant

  4. Overall Survival

    Time frame: 72 Hours Post-Transplant

    Time from transplant to death due to any cause.

  5. Overall Survival

    Time frame: 1 Year Post-Transplant

    Time from transplant to death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Sidoti

CONTACT

[email protected]

646-987-1371

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 25, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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