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

Clinical Risk Factors for Primary Graft Dysfunction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00552357
Enrollment
1150
Registered
2007-11-01
Start date
2007-12-01
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

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 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 68 Years
Healthy volunteers
No

Inclusion criteria

* Undergoing lung or combined heart and lung transplantation

Exclusion criteria

* Undergoing combined organ transplantation other than heart and lung transplantation

Design outcomes

Primary

MeasureTime frame
Primary graft dysfunction, defined by the ISHLT criteriaMeasured within 72 hours following transplantation

Countries

United States

Contacts

CONTACTE.J. Demissie, MSN
215-573-4767
PRINCIPAL_INVESTIGATORJason D. Christie, MD

University of Pennsylvania

Outcome results

None listed

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