Research on improving outcomes for lung transplant donors and recipients
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study
This study is trying to see how different donor and medical practices affect the health of lung transplant patients and donors, while also looking for blood markers that might predict complications after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 19 sites (Los Angeles, California and 18 other locations) |
| Trial ID | NCT06399302 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather extensive clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients across multiple centers. The research will focus on understanding how variations in donor and medical practices affect clinical outcomes and will identify serum biomarkers that predict post-transplant complications. Participants will be recruited either before their lung transplant or within 30 days after the procedure, with data collected during standard care visits to minimize additional burdens on participants. The study is designed to create a valuable resource for future research in lung transplantation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are listed for or have recently undergone a lung transplant.
Not a fit: Patients who are unwilling to provide informed consent or have significant medical issues that may complicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and better outcomes for lung transplant patients.
How similar studies have performed: Other studies have shown success in using similar observational approaches to improve transplant outcomes, indicating that this methodology is both tested and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to understand and provide informed consent 2. ≥ 18 years of age at the time of written informed consent 3. 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/exclusion criteria. Exclusion Criteria: 1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol 2. Pregnancy or plans to become pregnant 3. 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.
Where this trial is running
Los Angeles, California and 18 other locations
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California at San Francisco — San Francisco, California, United States (Recruiting)
- Stanford University Medical Center — Stanford, California, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Brigham and Womens Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- New York University — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Houston Methodist Hospital, Texas Medical Center — Houston, Texas, United States (Recruiting)
- Inova Fairfax Hospital — Falls Church, Virginia, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States (Recruiting)
- University Health Network — Toronto, Canada (Recruiting)
Study contacts
- Principal investigator: Scott M Palmer, MD, MHS — Duke University School of Medicine, Department of Medicine
- Study coordinator: Allyn Damman
- Email: allyn.damman@duke.edu
- Phone: 919-259-4414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.