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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Pennsylvania
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
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 (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00552357
First received: October 31, 2007
Last updated: August 24, 2016
Last verified: August 2016

October 31, 2007
August 24, 2016
December 2007
October 2016   (final data collection date for primary outcome measure)
Primary graft dysfunction, defined by the ISHLT criteria [ Time Frame: Measured within 72 hours following transplantation ] [ Designated as safety issue: No ]
Levels of protein C and other bleeding and clotting factors, 3-Nitrotyrosine, and protein carbonyls [ Time Frame: Measured 24 hours following lung transplantation ]
Complete list of historical versions of study NCT00552357 on ClinicalTrials.gov Archive Site
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Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Clinical Risk Factors for Primary Graft Dysfunction
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Blood samples
Non-Probability Sample
People undergoing lung transplantation
  • Primary Graft Dysfunction
  • Lung Transplantation
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Diamond JM, Lee JC, Kawut SM, Shah RJ, Localio AR, Bellamy SL, Lederer DJ, Cantu E, Kohl BA, Lama VN, Bhorade SM, Crespo M, Demissie E, Sonett J, Wille K, Orens J, Shah AS, Weinacker A, Arcasoy S, Shah PD, Wilkes DS, Ware LB, Palmer SM, Christie JD; Lung Transplant Outcomes Group. Clinical risk factors for primary graft dysfunction after lung transplantation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):527-34. doi: 10.1164/rccm.201210-1865OC. Epub 2013 Jan 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1150
October 2016
October 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Undergoing lung or combined heart and lung transplantation

Exclusion Criteria:

  • Undergoing combined organ transplantation other than heart and lung transplantation
Both
13 Years to 68 Years   (Child, Adult, Senior)
No
Contact: E.J. Demissie, MSN 215-573-4767
United States
 
NCT00552357
1417, R01HL087115-01A1
Yes
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University of Pennsylvania
University of Pennsylvania
  • National Heart, Lung, and Blood Institute (NHLBI)
  • 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
Principal Investigator: Jason D. Christie, MD University of Pennsylvania
University of Pennsylvania
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP