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

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ClinicalTrials.gov Identifier: NCT00457847
Recruitment Status : Recruiting
First Posted : April 9, 2007
Last Update Posted : July 11, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Vanderbilt University
Stanford University
University of Alabama at Birmingham
University of Michigan
Johns Hopkins University
Duke University
University of Pittsburgh
University of Chicago
Information provided by (Responsible Party):
University of Pennsylvania

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.

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 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.


Study Type : Observational
Estimated Enrollment : 1150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetics of Primary Graft Dysfunction
Study Start Date : February 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




Primary Outcome Measures :
  1. Genetic factors that increase the risk of developing PGD [ Time Frame: Measured through the use of genetic samples collected from participants ]

Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients going under lung transplant or heart & lung transplants
Criteria

Inclusion Criteria:

  • Undergoing lung transplant surgery

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): NCT00457847


Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jason D. Christie, MD    215-573-3209    jchristi@mail.med.upenn.edu   
Contact: Michelle Oyster, MS    215-573-4767    oysterm@mail.med.upenn.edu   
Principal Investigator: Jason D. Christie, MD         
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Vanderbilt University
Stanford University
University of Alabama at Birmingham
University of Michigan
Johns Hopkins University
Duke University
University of Pittsburgh
University of Chicago
Investigators
Principal Investigator: Jason D. Christie, MD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00457847     History of Changes
Other Study ID Numbers: 1380
R01HL081619 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by University of Pennsylvania:
PGD

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