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

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ClinicalTrials.gov Identifier: NCT00552357
Recruitment Status : Recruiting
First Posted : November 1, 2007
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Primary Graft Dysfunction Lung Transplantation

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.

Study Design

Study Type : Observational
Estimated Enrollment : 1150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Risk Factors for Primary Graft Dysfunction
Study Start Date : December 2007
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Primary graft dysfunction, defined by the ISHLT criteria [ Time Frame: Measured within 72 hours following transplantation ]

Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 68 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People undergoing lung transplantation

Inclusion Criteria:

  • Undergoing lung or combined heart and lung transplantation

Exclusion Criteria:

  • Undergoing combined organ transplantation other than heart and lung transplantation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552357

Contact: E.J. Demissie, MSN 215-573-4767

United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
University of Alabama at Birmingham
Vanderbilt University
Stanford University
Johns Hopkins University
University of Michigan
Duke University
University of Pittsburgh
University of Chicago
Principal Investigator: Jason D. Christie, MD University of Pennsylvania
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00552357     History of Changes
Other Study ID Numbers: 1417
R01HL087115-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Primary Graft Dysfunction
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes