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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was Recruiting

Sponsor:

Collaborators:

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:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00457847

First received: April 5, 2007

Last updated: July 14, 2009

Last verified: July 2009

History of Changes

Purpose

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
Primary Graft Dysfunction Lung Transplantation


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Genetics of Primary Graft Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

U.S. FDA Resources

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

Primary Outcome Measures:

Genetic factors that increase the risk of developing PGD [ Time Frame: Measured through the use of genetic samples collected from participants ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Blood samples


Estimated Enrollment:	1150
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2012

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.

Eligibility


Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: E.J. Demissie, MSN 215-573-4767 edemissi@mail.med.upenn.edu
Principal Investigator: Jason D. Christie, MD

Sponsors and 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

Investigators


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

More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional 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:	Jason Christie, MD, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00457847 History of Changes
Other Study ID Numbers:	1380, R01 HL081619
Study First Received:	April 5, 2007
Last Updated:	July 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):


PGD

Additional relevant MeSH terms:


Primary Graft Dysfunction Cardiovascular Diseases Pathologic Processes	Postoperative Complications Reperfusion Injury Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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