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NCT00457847 Clinical Trial

Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation

Lung Transplantation Clinical Trial

Official title:
Genetics of Primary Graft Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00457847
Other study ID # 1380
Secondary ID R01HL081619
Status Recruiting
Phase
First received
Last updated
Start date February 2007
Est. completion date June 2024

Study information
Verified date July 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following lung transplant surgery. The purpose of this study is to identify genetic factors that may put someone at risk for developing PGD.

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 this condition is often expensive, and it is the leading cause of death following lung transplant. Many potential donors and recipients are considered unsuitable for lung transplant because of concern for the development of PGD. Therefore, the ability to accurately predict which individuals are at risk for developing PGD may allow more lung transplants to be performed. Specific characteristics in both lung donors and recipients may play an important role in determining the risk of PGD. For example, genetic variations in how the body deals with harmful chemicals called oxidants may be associated with the development of PGD. The purpose of this study is to identify the specific genetic biomarkers in donors and recipients that put individuals at risk for developing PGD following a lung transplant. This study will enroll individuals who are undergoing lung transplantation. Blood samples will be collected from lung donors and from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will monitor participants for 72 hours following surgery for symptoms of PGD. 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 15 Years to 65 Years
Eligibility Inclusion Criteria: - Undergoing lung transplant surgery Exclusion Criteria: - Individuals undergoing multi-organ transplantation except heart/lung transplants

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 ISHLT standard definition and grading system will be used First 72 hours post lung transplantation
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