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

This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), August 2008

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
  Purpose

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   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Clinical Risk Factors for Primary Graft Dysfunction

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Levels of protein C and other bleeding and clotting factors, 3-Nitrotyrosine, and protein carbonyls [ Time Frame: Measured 24 hours following lung transplantation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Blood samples


Estimated Enrollment:   1150
Study Start Date:   December 2007
Estimated Study Completion Date:   October 2011

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.

  Eligibility
Ages Eligible for Study:   13 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

People undergoing lung transplantation


Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552357

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

Locations
United States, Pennsylvania
University of Pennsylvania     Recruiting
      Philadelphia, Pennsylvania, United States

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

Investigators
Principal Investigator:     Jason D. Christie, MD     University of Pennsylvania    
  More Information


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

ClinicalTrials.gov processed this record on October 07, 2008




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