Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDuke University

About this trial

This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and provide informed consent

≥ 18 years of age at the time of written informed consent

Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days

Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion/

Disqualifiers

Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol

Pregnancy or plans to become pregnant

Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Trial population

Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,600 Participants
are grouped into 1 trial group
Group A: Lung transplant donors and recipients

Trial outcomes

Primary outcomes

1

Number of participants enrolled and critical variable completeness

To collect detailed clinical data, blood samples (including DNA), and PROs in 2,600 lung transplant candidates, donors, and recipients across the participating LTC centers to create a robust resource that will support a broad range of additional future clinical and translational research objectives

Time frame
3 years
2

Number of PROs collected per patient

To collect clinical data and PROs that will specifically support future research studies to determine how variation in donor, surgical, or medical management practices across the participating LTC centers are associated with specific differences in relevant clinical outcomes such as PGD, AR, AMR, ALAD, post-transplant infections, PROs including health-related quality of life, or one-year survival.

Time frame
3 years
3

Number of specimens per participant collected

To collect clinical data and biosamples that will specifically support future research studies to identify serum biomarkers that are associated with or predict the development of PGD, AR, AMR, ALAD, or CLAD.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Duke University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

University of Pennsylvania

Collaborator