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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Diamond JM, Akimova T, Kazi A, Shah RJ, Cantu E, Feng R, Levine MH, Kawut SM, Meyer NJ, Lee JC, Hancock WW, Aplenc R, Ware LB, Palmer SM, Bhorade S, Lama VN, Weinacker A, Orens J, Wille K, Crespo M, Lederer DJ, Arcasoy S, Demissie E, Christie JD; Lung Transplant Outcomes Group. Genetic variation in the prostaglandin E2 pathway is associated with primary graft dysfunction. Am J Respir Crit Care Med. 2014 Mar 1;189(5):567-75. doi: 10.1164/rccm.201307-1283OC.

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
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