Transplanting Lungs From Uncontrolled Donation After Circulatory Death

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327945
• Other study ID #: 22-00009
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Carolyn Sidoti
• Phone: 646-987-1371
• Email: Carolyn.Sidoti[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)		72 Hours Post-Transplant
Secondary	Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO)		1 Year Post-Transplant
Secondary	Incidence of Re-Transplantation		1 Year Post-Transplant
Secondary	Overall Survival	Time from transplant to death due to any cause.	72 Hours Post-Transplant
Secondary	Overall Survival	Time from transplant to death due to any cause.	1 Year Post-Transplant