Trial record 3 of 92 for:    Lung Transplant | Open Studies | NIH, U.S. Fed

Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After 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
University of Alabama at Birmingham
Vanderbilt University
Stanford University
Johns Hopkins University
University of Michigan
Duke University
University of Pittsburgh
University of Chicago
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00552357
First received: October 31, 2007
Last updated: July 14, 2009
Last verified: July 2009
  Purpose

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
Primary Graft Dysfunction
Lung Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Risk Factors for Primary Graft Dysfunction

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary graft dysfunction, defined by the ISHLT criteria [ Time Frame: Measured within 72 hours following transplantation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 1150
Study Start Date: December 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People undergoing lung transplantation

Criteria

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
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: NCT00552357

Contacts
Contact: E.J. Demissie, MSN 215-573-4767

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Columbia University
University of Alabama at Birmingham
Vanderbilt University
Stanford University
Johns Hopkins University
University of Michigan
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):
Responsible Party: Jason Christie, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00552357     History of Changes
Other Study ID Numbers: 1417, R01 HL087115-01A1
Study First Received: October 31, 2007
Last Updated: July 14, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 23, 2014