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Sponsors and Collaborators: |
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 |
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00552357 |
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 |
Primary Graft Dysfunction Lung Transplantation |
MedlinePlus related topics: | Lung Transplantation |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Clinical Risk Factors for Primary Graft Dysfunction |
Blood samples
Estimated Enrollment: | 1150 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | October 2011 |
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.
Ages Eligible for Study: | 13 Years to 68 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People undergoing lung transplantation
Inclusion Criteria:
Exclusion Criteria:
Contact: E.J. Demissie, MSN | 215-573-4767 |
United States, Pennsylvania | |||||
University of Pennsylvania | Recruiting | ||||
Philadelphia, Pennsylvania, United States |
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 |
Principal Investigator: | Jason D. Christie, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Jason Christie, MD ) |
Study ID Numbers: | 1417, R01 HL087115-01A1 |
First Received: | October 31, 2007 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00552357 |
Health Authority: | United States: Federal Government |