Health TrialsbyHealthPanel

Transplanting Lungs From Uncontrolled Donation After Circulatory Death

ConditionLung Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients waiting for lung transplants

Willing to participate in the research study

Disqualifiers

Unable to be followed for 1 year after transplantation

Unable to provide written informed consent to participate in the research (or designate a surrogate)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Lung uDCD ProtocolExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
72 Hours Post-Transplant

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 from transplant to death due to any cause.

Time frame
72 Hours Post-Transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
Apply now