Actively Recruiting

Age: 13Years - 68Years
All Genders
ID00552357

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

Age: 13Years - 68Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing lung or combined heart and lung transplantation
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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

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Published Research Related To This Trial