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Inflammation and the Host Response to Injury (Burns)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257244
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : March 7, 2019
Information provided by (Responsible Party):
Ronald G. Tompkins, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to help improve our understanding of the biology involved in the body's response to serious trauma or burn injury. The host response to trauma and burns is a collection of physiological and pathophysiological processes that depend critically upon the regulation of the human innate immune system, with particular emphasis on the inflammatory component of that system. No single research center or small group of centers has the capacity to delineate the integrated response of this complex biological system, which involves multiple molecular and genetic interactions that vary in time. Our proposal promotes the identification of important dynamic relationships that regulate the integration of this complex biological system, with the expectation that this understanding will ultimately impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.

Condition or disease
Trauma Burns Multiple Organ Failure

Detailed Description:
This large-scale collaborative project provides the means to acquire the necessary new knowledge directly in humans. Knowledge will be acquired using diverse state-of-the-art genomic and proteomic technologies, a highly complex clinical, proteomic, and genomic database, as well as newly-developed, novel analytical tools to probe this complex dataset. Our analytical capabilities at the genomic and proteomic level are now rapidly evolving and our ability to link these genomic and proteomic data to pathways and functional modules will help us more closely link this cellular data to immunological processes and ultimately, to the phenotypic response (i.e., trajectory) in the injured host. As a result, potential interventions, whether through our Program or other funding mechanisms, can be more effectively designed.

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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation and the Host Response to Injury
Study Start Date : April 2004
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Primary Outcome Measures :
  1. Time to death [ Time Frame: Within two years of burn injury ]
  2. Change in gene expression after burn injury [ Time Frame: Up to two years after burn injury ]
  3. Number and type of complications [ Time Frame: Up to two years after burn injury ]

Biospecimen Retention:   Samples Without DNA
Plasma, blood leukocyte nucleic acids (RNA), solid tissue nucleic acids (only RNA, no DNA)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute hospitalized burn patients

Inclusion Criteria:

  • Burn patients of all ages with 20% or greater of total body surface area burns that require surgical treatment
  • Burn patients admitted to the burn unit within 96 hours (4 days) of burn injury

All patients meeting these criteria are entered into the epidemiologic database and assessed for specific exclusion criteria to establish whether serial blood draws are warranted.

Exclusion Criteria:

  • Injury caused by chemical agent
  • Deep injury caused by conduction of electrical current or charge
  • Decision not to treat due to severity of injury
  • Anoxic brain injury that is not expected to result in complete recovery
  • Associated multiple injuries exclusive of burns (ISS >=25)
  • Pre-morbid condition: Severe congestive heart failure (measured ejection fraction <20%)
  • Pre-morbid condition: Malignancy currently under treatment
  • Pre-morbid condition: Medical condition requiring systemic glucocorticoid treatment
  • Pre-morbid condition: current systemic immunosuppression for organ transplant or chronic inflammatory condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257244

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United States, Illinois
Loyola University Medical Center at Loyola in Chicago
Maywood, Illinois, United States, 60153
United States, Texas
Southwestern Medical Center at University of Texas Southwestern
Dallas, Texas, United States, 75390
University of Texas at Galveston-Shriners Burn Hospital- Galveston
Galveston, Texas, United States, 77550
United States, Washington
Harborview Medical Center at University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Ronald G. Tompkins, MD, ScD Massachusetts General Hospital
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Ronald G. Tompkins, Chief, Burns Service, Massachusetts General Hospital Identifier: NCT00257244    
Other Study ID Numbers: 2 U54 GM062119_burn
U54GM062119 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Curated and validated data are available to Consortium Members
Keywords provided by Ronald G. Tompkins, Massachusetts General Hospital:
Immunity, innate
Additional relevant MeSH terms:
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Multiple Organ Failure
Pathologic Processes