Clinical trial NCT00552357: Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Official title: Clinical Risk Factors for Primary Graft Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Graft Dysfunction
Lung Transplantation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Columbia University
name: University of Alabama at Birmingham
name: Vanderbilt University
name: Stanford University
name: Johns Hopkins University
name: University of Michigan
name: Duke University
name: University of Pittsburgh
name: University of Chicago
First posted: 2007-11-01
Enrollment: 1150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 68
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People undergoing lung transplantation

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.

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 criteria: Inclusion Criteria:

* Undergoing lung or combined heart and lung transplantation

Exclusion Criteria:

* Undergoing combined organ transplantation other than heart and lung transplantation

Primary outcomes:
measure: Primary graft dysfunction, defined by the ISHLT criteria
timeFrame: Measured within 72 hours following transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jason D. Christie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.