Clinical Trial: Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Clinical Risk Factors for Primary Graft Dysfunction

Brief Summary: Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant.

Detailed Summary:

PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for PGD is often expensive, and it is the leading cause of death following lung transplantation. Many potential lung donors and recipients are considered unsuitable for lung transplantation because of concern for the development of PGD. Increased levels of chemicals that are involved in bleeding and clotting, including protein C, and certain markers of oxidant stress, which can cause damage to the body's cells and tissues, may increase a person's risk of developing complications following a lung transplant. The purpose of this study is to analyze blood samples to determine if elevated levels of certain chemicals may be associated with an increased risk of developing PGD after lung transplantation.

This study will enroll individuals who are undergoing lung or heart and lung transplantation. Blood samples will be collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will also review participants' medical records. There will be no additional study visits.

Sponsor: University of Pennsylvania

Current Primary Outcome: Primary graft dysfunction, defined by the ISHLT criteria [ Time Frame: Measured within 72 hours following transplantation ]

Original Primary Outcome: Levels of protein C and other bleeding and clotting factors, 3-Nitrotyrosine, and protein carbonyls [ Time Frame: Measured 24 hours following lung transplantation ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: October 31, 2007
Date Started: December 2007
Date Completion: June 2018
Last Updated: January 10, 2017
Last Verified: January 2017