PROMISE: A Prospective Multicenter Study to Evaluate Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes is an observational, prospective multicenter cohort study of up to 2,600 lung transplant candidates and recipients. The objectives of this study are to:
- Create a prospective multicenter cohort of lung transplant candidates, donors, and recipients that includes detailed clinical information, biological samples, and measures of physical function and patient reported outcomes.
- Create a virtual community and identify participaants interested in engaging in upcoming research studies.
- Create a dataset of health-related measurements, risk factors, and outcomes for future analysis.
Participants in this study provide samples prior to transplant, during the perioperative period, and periodically up to four years post transplant.
This is a Lung Transplant Consortium study. The lead sites for this study are Duke University and the University of Pennsylvania, with 17 other supporting sites, including the Univeristy of Wisconsin – Madison. Funding for this project is anticipated to run through the end of 2028.
Enrollment
A research coordinator will approach potential participants one they are approved for listing to guage interest in this study. If interested, they will schedule a time to meet in clinic or virtually to go over the informed consent document and sign, after which they will be enrolled.
Enrollment will last for a minimum of 1 year and a maximum of 4 years, depending on year of enrollment.
Study Procedures
Blood samples are a large part of pre and post transplant care.
This study will collect blood with some of these draws whenever possible.
Collection timepoints are:
- Pre-Transplant
- Post op day 3, at time of hospital discharge
- 3 months and 12 months post transplant
- 2 years, 3 years, and 4 years after transplant, depending on year of enrollment
This study plans to collect information from participants electronic medical record.
Information collected includes:
- Date of birth, race and ethnicity, sex, and gender
- Health history, medications, vaccines, and health insurance
- Reason for transplant
- Laboratory results, imaging data, medical procedure dates and results
- Lung donor clinical information
This study will contact participants at periodic timepoints to ask questions related to participants’ quality of life.
These timepoints are pre-transplant and annually post transplant, up to four years, depending on participant’s year of enrollment.
Topics asked about may include:
- Lung and respiratory problems
- Treatments
- Daily activities
- Emotions and moods