Actively Recruiting
Clinical Risk Factors for Primary Graft Dysfunction After Lung or Heart-Lung Transplantation
Led by University of Pennsylvania · Updated on 2025-07-16
1150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Primary graft dysfunction (PGD) is a serious lung problem that can happen within days after lung transplant surgery. This condition affects up to 25% of lung transplant patients and involves fluid buildup in the lungs and low oxygen levels in the blood. PGD is the leading cause of death after lung transplantation and often leads to high treatment costs. The study aims to find out if high levels of certain chemicals in the blood are linked to a greater risk of developing PGD after a lung transplant. The study will enroll people undergoing lung or combined heart and lung transplants. Blood samples will be taken before surgery, right after surgery, and 24 hours later to measure levels of chemicals related to bleeding, clotting, and cell damage. Researchers will also review participants' medical records. There are no extra study visits required beyond the scheduled transplant care. Participants will be monitored mainly by analyzing blood samples and medical records to check for PGD within 72 hours after transplantation, based on established criteria. There is no intervention or treatment being tested, as this is an observational study focused on identifying risk factors. The study will last through the transplant period with no additional visits, and safety will be monitored through routine clinical care.
CONDITIONS
Brief Title
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing lung or combined heart and lung transplantation
You will not qualify if you...
- Undergoing combined organ transplantation other than heart and lung transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 72 hours following transplantation
Blood samples are collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery to analyze risk factors for primary graft dysfunction.
3 blood sample collections (no additional study visits)
Duration - Up to 72 hours following transplantation
Participants' medical records are reviewed to assess the development of primary graft dysfunction after lung transplantation.
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
E
E.J. Demissie, MSN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0