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

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT00457847

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Columbia University (Other), Vanderbilt University (Other), Stanford University (Other), University of Alabama at Birmingham (Other), University of Michigan (Other), Johns Hopkins University (Other), Duke University (Other), University of Pittsburgh (Other), University of Chicago (Other)

1,150

Enrollment

Location

195.9

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated Enrollment :

1150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Genetics of Primary Graft Dysfunction

Study Start Date :

Feb 1, 2007

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

Primary graft dysfunction [First 72 hours post lung transplantation]
ISHLT standard definition and grading system will be used

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undergoing lung transplant surgery

Exclusion Criteria:

Individuals undergoing multi-organ transplantation except heart/lung transplants

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT00457847

Other Study ID Numbers:

1380
R01HL081619

First Posted:

Apr 9, 2007

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Keywords provided by University of Pennsylvania

PGD

Additional relevant MeSH terms:

Primary Graft Dysfunction

Study Results

No Results Posted as of Aug 19, 2022