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NCT00552357 Clinical Trial

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

Lung Transplantation Clinical Trial

Official title:
Clinical Risk Factors for Primary Graft Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00552357
Other study ID # 1417
Secondary ID R01HL087115-01A1
Status Recruiting
Phase
First received
Last updated
Start date December 2007
Est. completion date June 2024

Study information
Verified date July 2023
Source University of Pennsylvania
Contact E.J. Demissie, MSN
Phone 215-573-4767
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1150
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 68 Years
Eligibility Inclusion Criteria: - Undergoing lung or combined heart and lung transplantation Exclusion Criteria: - Undergoing combined organ transplantation other than heart and lung transplantation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (11)
Lead Sponsor Collaborator
University of Pennsylvania Columbia University, Duke University, Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), Stanford University, University of Alabama at Birmingham, University of Chicago, University of Michigan, University of Pittsburgh, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary graft dysfunction, defined by the ISHLT criteria Measured within 72 hours following transplantation
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