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OpenTrials
Active, Not Recruiting

NCT Number: NCT00457847

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing lung transplant surgery

Exclusion criteria

  • Individuals undergoing multi-organ transplantation except heart/lung transplants

Treatment and study plan

Primary outcomes

  1. Primary graft dysfunction

    Time frame: First 72 hours post lung transplantation

    ISHLT standard definition and grading system will be used

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • 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

Registry information

Official study title

Genetics of Primary Graft Dysfunction

Important dates

Study start
2007
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2007
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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