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

Genetics of Primary Graft Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00457847
Enrollment
1150
Registered
2007-04-09
Start date
2007-02-01
Completion date
2027-06-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplantation, Primary Graft Dysfunction

Keywords

PGD

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Columbia University
CollaboratorOTHER
Vanderbilt University
CollaboratorOTHER
Stanford University
CollaboratorOTHER
University of Alabama at Birmingham
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Duke University
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
University of Chicago
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Undergoing lung transplant surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Primary graft dysfunctionFirst 72 hours post lung transplantationISHLT standard definition and grading system will be used

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJason D. Christie, MD

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026