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

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT00552357

Collaborator

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

1,150

Enrollment

Location

186

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1150 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Clinical Risk Factors for Primary Graft Dysfunction

Study Start Date :

Dec 1, 2007

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

Primary graft dysfunction, defined by the ISHLT criteria [Measured within 72 hours following transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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:

NCT00552357

Other Study ID Numbers:

1417
R01HL087115-01A1

First Posted:

Nov 1, 2007

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Additional relevant MeSH terms:

Primary Graft Dysfunction

Study Results

No Results Posted as of Jul 25, 2022