Inflammation and the Host Response to Injury (Trauma)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Ronald G Tompkins, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00257231
First received: November 18, 2005
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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
Trauma
Burns
Multiple Organ Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation and the Host Response to Injury

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • Time to death [ Time Frame: Within 28 after trauma injury ] [ Designated as safety issue: No ]
  • Change in gene expression after trauma injury [ Time Frame: Up to 28 days after trauma injury ] [ Designated as safety issue: No ]
  • Number and types of complications [ Time Frame: Up to 28 days after trauma injury ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma, blood leukocyte nucleic acids (only RNA, no DNA)


Estimated Enrollment: 610
Study Start Date: November 2003
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute hospitalized blunt trauma patients

Criteria

Inclusion criteria for enrollment in the trauma study are as follows:

  • Blunt trauma without isolated head injury
  • Absence of traumatic brain injury, defined as either AIS head <4 OR GCS motor >3 within 24 hours of injury
  • Emergency Department arrival <=6 hours from time of injury
  • Blood transfusion within 12 hours of injury
  • Base deficit >=6 OR systolic blood pressure <90 mmHg within 60 minutes of emergency department arrival
  • Fully or partially intact cervical spinal cord

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.

The presence of any of the following exclusion criteria disqualifies a subject from the trauma sampling study.

  • Age < 16
  • Anticipated survival of <24 hours from injury
  • Anticipated survival <28 days due to pre-existing medical condition
  • Inability to obtain first blood draw within first 12 hours after injury
  • Traumatic brain injury; i.e., GCS ≤8 after ICU admission AND brain computerized tomography scan abnormality within 12 hours after injury
  • Inability to obtain informed consent
  • Pre-existing, ongoing immunosuppression - e.g. transplant recipient
  • Pre-existing, ongoing immunosuppression - e.g. chronic high dose corticosteroids (>20 mg/prednisone-equivalents/day)
  • Pre-existing, ongoing immunosuppression - e.g. oncolytic drug(s) therapy within the past 14 days
  • Pre-existing, ongoing immunosuppression - e.g. HIV positive AND CD4 count <200 cells/mm3
  • Possible requirement for early immunosuppression - e.g. significant likelihood of requiring high dose corticosteroids (e.g. spinal injury)
  • Significant pre-existing organ dysfunction - lung: currently receiving home oxygen therapy, as documented in medical records
  • Significant pre-existing organ dysfunction - heart: congestive heart failure, as documented in medical records
  • Significant pre-existing organ dysfunction - renal: chronic renal failure (creatinine >2)
  • Significant pre-existing organ dysfunction - liver: cirrhosis with portal hypertension or encephalopathy
  • Patient injured while sampling enrollment temporarily on hold
  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: NCT00257231

Locations
United States, Colorado
Denver Health Medical Center at University of Colorado
Denver, Colorado, United States, 80204
United States, Pennsylvania
Presbyterian University Hospital at University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Southwestern Medical Center at University of Texas Southwestern
Dallas, Texas, United States, 75390
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Principal Investigator: Ronald G Tompkins, MD, ScD Massachusetts General Hospital/Shriners Burn Hospital - Boston
  More Information

Additional Information:
Publications:
Cobb JP, Mindrinos MN, Miller-Graziano C, Calvano SE, Baker HV, Xiao W, Laudanski K, Brownstein BH, Elson CM, Hayden DL, Herndon DN, Lowry SF, Maier RV, Schoenfeld DA, Moldawer LL, Davis RW, Tompkins RG, Baker HV, Bankey P, Billiar T, Brownstein BH, Calvano SE, Camp D, Chaudry I, Cobb JP, Davis RW, Elson CM, Freeman B, Gamelli R, Gibran N, Harbrecht B, Hayden DL, Heagy W, Heimbach D, Herndon DN, Horton J, Hunt J, Laudanski K, Lederer J, Lowry SF, Maier RV, Mannick J, McKinley B, Miller-Graziano C, Mindrinos MN, Minei J, Moldawer LL, Moore E, Moore F, Munford R, Nathens A, O'keefe G, Purdue G, Rahme L, Remick D, Sailors M, Schoenfeld DA, Shapiro M, Silver G, Smith R, Stephanopoulos G, Stormo G, Tompkins RG, Toner M, Warren S, West M, Wolfe S, Xiao W, Young V; Inflammation and Host Response to Injury Large-Scale Collaborative Research Program. Application of genome-wide expression analysis to human health and disease. Proc Natl Acad Sci U S A. 2005 Mar 29;102(13):4801-6. Epub 2005 Mar 21.

Responsible Party: Dr. Ronald G Tompkins, Chief, Burns Service, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00257231     History of Changes
Other Study ID Numbers: 2 U54 GM062119_trauma, NIH 2 U54 GM062119
Study First Received: November 18, 2005
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Immunity, innate
Inflammation
Genomics
Proteomics

Additional relevant MeSH terms:
Inflammation
Multiple Organ Failure
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on September 18, 2014