Full Text View
Tabular View
No Study Results Posted
Related Studies
Inflammation and the Host Response to Injury (Trauma)
This study is currently recruiting participants.
Verified by National Institute of General Medical Sciences (NIGMS), January 2009
First Received: November 18, 2005   Last Updated: January 15, 2009   History of Changes
Sponsored by: National Institute of General Medical Sciences (NIGMS)
Information provided by: National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00257231
  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: Cohort, Prospective
Official Title: Inflammation and the Host Response to Injury

Resource links provided by NLM:

MedlinePlus related topics: Burns Injuries Wounds
U.S. FDA Resources

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

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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


Estimated Enrollment: 610
Study Start Date: November 2003
Estimated Study Completion Date: September 2010
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257231

Contacts
Contact: Ronald V. Maier, MD 206-731-3299 ronmaier@u.washington.edu
Contact: Ronald G Tompkins, MD, ScD 617-726-3447 rtompkins@partners.org

Locations
United States, Colorado
Denver Health Medical Center at University of Colorado Recruiting
Denver, Colorado, United States, 80204
Contact: Natalya Nazarenko     303-436-8321     Natalya.Nazarenko@dhha.org    
Principal Investigator: Ernest Moore, MD            
United States, Pennsylvania
Presbyterian University Hospital at University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Barbara Early, RN, CCRC     412-647-9745     earlybj@upmc.edu    
Principal Investigator: Juan Ochoa, MD            
United States, Texas
Southwestern Medical Center at University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Sue Vanek, RN     214-648-3948     Sue.Vanek@utsouthwestern.edu    
Principal Investigator: Joseph Minei, MD            
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Laura Hennessy, RN     206-341-4323     hennessy@u.washington.edu    
Principal Investigator: Ronald Maier, MD            
Sub-Investigator: Joseph Cuschieri, MD            
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Ronald G Tompkins, MD, ScD Massachusetts General Hospital/Shriners Burn Hospital - Boston
  More Information

Additional Information:
Information about the study and its goals. Contains links to study related publications, resources, and participating institutions  This link exits the ClinicalTrials.gov site

Publications:
Siddiqui J, Remick DG. Improved sensitivity of colorimetric compared to chemiluminescence ELISAs for cytokine assays. J Immunoassay Immunochem. 2003;24(3):273-83.
Shen Y, Jacobs JM, Camp DG 2nd, Fang R, Moore RJ, Smith RD, Xiao W, Davis RW, Tompkins RG. Ultra-high-efficiency strong cation exchange LC/RPLC/MS/MS for high dynamic range characterization of the human plasma proteome. Anal Chem. 2004 Feb 15;76(4):1134-44.
Irimia D, Tompkins RG, Toner M. Single-cell chemical lysis in picoliter-scale closed volumes using a microfabricated device. Anal Chem. 2004 Oct 15;76(20):6137-43.
Sethu P, Anahtar M, Moldawer LL, Tompkins RG, Toner M. Continuous flow microfluidic device for rapid erythrocyte lysis. Anal Chem. 2004 Nov 1;76(21):6247-53.
Feezor RJ, Baker HV, Mindrinos M, Hayden D, Tannahill CL, Brownstein BH, Fay A, MacMillan S, Laramie J, Xiao W, Moldawer LL, Cobb JP, Laudanski K, Miller-Graziano CL, Maier RV, Schoenfeld D, Davis RW, Tompkins RG; Inflammation and Host Response to Injury, Large-Scale Collaborative Research Program. Whole blood and leukocyte RNA isolation for gene expression analyses. Physiol Genomics. 2004 Nov 17;19(3):247-54.
Murthy SK, Sin A, Tompkins RG, Toner M. Effect of flow and surface conditions on human lymphocyte isolation using microfluidic chambers. Langmuir. 2004 Dec 21;20(26):11649-55.
Qian WJ, Jacobs JM, Camp DG 2nd, Monroe ME, Moore RJ, Gritsenko MA, Calvano SE, Lowry SF, Xiao W, Moldawer LL, Davis RW, Tompkins RG, Smith RD. Comparative proteome analyses of human plasma following in vivo lipopolysaccharide administration using multidimensional separations coupled with tandem mass spectrometry. Proteomics. 2005 Feb;5(2):572-84.
Copeland S, Warren HS, Lowry SF, Calvano SE, Remick D; Inflammation and the Host Response to Injury Investigators. Acute inflammatory response to endotoxin in mice and humans. Clin Diagn Lab Immunol. 2005 Jan;12(1):60-7.
Qian WJ, Monroe ME, Liu T, Jacobs JM, Anderson GA, Shen Y, Moore RJ, Anderson DJ, Zhang R, Calvano SE, Lowry SF, Xiao W, Moldawer LL, Davis RW, Tompkins RG, Camp DG 2nd, Smith RD; Inflammation and the Host Response to Injury Large Scale Collaborative Research Program. Quantitative proteome analysis of human plasma following in vivo lipopolysaccharide administration using 16O/18O labeling and the accurate mass and time tag approach. Mol Cell Proteomics. 2005 May;4(5):700-9. Epub 2005 Mar 7.
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.
Toner M, Irimia D. Blood-on-a-chip. Annu Rev Biomed Eng. 2005;7:77-103. Review.
Calvano SE, Xiao W, Richards DR, Felciano RM, Baker HV, Cho RJ, Chen RO, Brownstein BH, Cobb JP, Tschoeke SK, Miller-Graziano C, Moldawer LL, Mindrinos MN, Davis RW, Tompkins RG, Lowry SF; Inflamm and Host Response to Injury Large Scale Collab. Res. Program. A network-based analysis of systemic inflammation in humans. Nature. 2005 Oct 13;437(7061):1032-7. Epub 2005 Aug 31.
Storey JD, Xiao W, Leek JT, Tompkins RG, Davis RW. Significance analysis of time course microarray experiments. Proc Natl Acad Sci U S A. 2005 Sep 6;102(36):12837-42. Epub 2005 Sep 2.
Shen Y, Kim J, Strittmatter EF, Jacobs JM, Camp DG 2nd, Fang R, Tolie N, Moore RJ, Smith RD. Characterization of the human blood plasma proteome. Proteomics. 2005 Oct;5(15):4034-45.
De AK, Miller-Graziano CL, Calvano SE, Laudanski K, Lowry SF, Moldawer LL, Remick DG Jr, Rajicic N, Schoenfeld D, Tompkins RG. Selective activation of peripheral blood T cell subsets by endotoxin infusion in healthy human subjects corresponds to differential chemokine activation. J Immunol. 2005 Nov 1;175(9):6155-62.
Nathens AB, Johnson JL, Minei JP, Moore EE, Shapiro M, Bankey P, Freeman B, Harbrecht BG, Lowry SF, McKinley B, Moore F, West M, Maier RV; Inflammation and the Host Response to Injury Investigators. Inflammation and the Host Response to Injury, a large-scale collaborative project: Patient-Oriented Research Core--standard operating procedures for clinical care. I. Guidelines for mechanical ventilation of the trauma patient. J Trauma. 2005 Sep;59(3):764-9. No abstract available.
Brownstein BH, Logvinenko T, Lederer JA, Cobb JP, Hubbard WJ, Chaudry IH, Remick DG, Baker HV, Xiao W, Mannick JA. Commonality and differences in leukocyte gene expression patterns among three models of inflammation and injury. Physiol Genomics. 2006 Feb 14;24(3):298-309. Epub 2005 Dec 20.
Liu T, Qian WJ, Gritsenko MA, Xiao W, Moldawer LL, Kaushal A, Monroe ME, Varnum SM, Moore RJ, Purvine SO, Maier RV, Davis RW, Tompkins RG, Camp DG 2nd, Smith RD; Inflammation and the Host Response to Injury Large Scale Collaborative Research Programm. High dynamic range characterization of the trauma patient plasma proteome. Mol Cell Proteomics. 2006 Oct;5(10):1899-913. Epub 2006 May 9.
Minei JP, Nathens AB, West M, Harbrecht BG, Moore EE, Shapiro MB, Bankey PE, Johnson JL, Freeman B, McKinley BA, Moore FA, Maier RV; Inflammation and the Host Response to Injury Large Scale Collaborative Research Program Investigators. Inflammation and the Host Response to Injury, a Large-Scale Collaborative Project: patient-oriented research core--standard operating procedures for clinical care. II. Guidelines for prevention, diagnosis and treatment of ventilator-associated pneumonia (VAP) in the trauma patient. J Trauma. 2006 May;60(5):1106-13; discussion 1113. No abstract available.
Klein MB, Silver G, Gamelli RL, Gibran NS, Herndon DN, Hunt JL, Tompkins RG; Inflammation and the Host Response to Injury Investigators. Inflammation and the host response to injury: an overview of the multicenter study of the genomic and proteomic response to burn injury. J Burn Care Res. 2006 Jul-Aug;27(4):448-51.
Moore FA, McKinley BA, Moore EE, Nathens AB, West M, Shapiro MB, Bankey P, Freeman B, Harbrecht BG, Johnson JL, Minei JP, Maier RV. Inflammation and the Host Response to Injury, a large-scale collaborative project: patient-oriented research core--standard operating procedures for clinical care. III. Guidelines for shock resuscitation. J Trauma. 2006 Jul;61(1):82-9. Review. No abstract available.
Sethu P, Moldawer LL, Mindrinos MN, Scumpia PO, Tannahill CL, Wilhelmy J, Efron PA, Brownstein BH, Tompkins RG, Toner M. Microfluidic isolation of leukocytes from whole blood for phenotype and gene expression analysis. Anal Chem. 2006 Aug 1;78(15):5453-61.
Qian WJ, Jacobs JM, Liu T, Camp DG 2nd, Smith RD. Advances and challenges in liquid chromatography-mass spectrometry-based proteomics profiling for clinical applications. Mol Cell Proteomics. 2006 Oct;5(10):1727-44. Epub 2006 Aug 3. Review.
West MA, Shapiro MB, Nathens AB, Johnson JL, Moore EE, Minei JP, Bankey PE, Freeman B, Harbrecht BG, McKinley BA, Moore FA, Maier RV. Inflammation and the host response to injury, a large-scale collaborative project: Patient-oriented research core-standard operating procedures for clinical care. IV. Guidelines for transfusion in the trauma patient. J Trauma. 2006 Aug;61(2):436-9. No abstract available.
Rajicic N, Finkelstein DM, Schoenfeld DA; Inflammation Host Response to Injury Research Program Investigators. Survival analysis of longitudinal microarrays. Bioinformatics. 2006 Nov 1;22(21):2643-9. Epub 2006 Oct 10.
Laudanski K, Miller-Graziano C, Xiao W, Mindrinos MN, Richards DR, De A, Moldawer LL, Maier RV, Bankey P, Baker HV, Brownstein BH, Cobb JP, Calvano SE, Davis RW, Tompkins RG. Cell-specific expression and pathway analyses reveal alterations in trauma-related human T cell and monocyte pathways. Proc Natl Acad Sci U S A. 2006 Oct 17;103(42):15564-9. Epub 2006 Oct 10.
Silver GM, Klein MB, Herndon DN, Gamelli RL, Gibran NS, Altstein L, McDonald-Smith GP, Tompkins RG, Hunt JL; The Inflammation and the Host Response to Trauma, Collaborative Research Program. Standard operating procedures for the clinical management of patients enrolled in a prospective study of Inflammation and the Host Response to Thermal Injury. J Burn Care Res. 2007 Mar-Apr;28(2):222-30.
Nathens AB, McMurray MK, Cuschieri J, Durr EA, Moore EE, Bankey PE, Freeman B, Harbrecht BG, Johnson JL, Minei JP, McKinley BA, Moore FA, Shapiro MB, West MA, Tompkins RG, Maier RV. The practice of venous thromboembolism prophylaxis in the major trauma patient. J Trauma. 2007 Mar;62(3):557-62; discussion 562-3.
Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8.
Leek JT, Storey JD. Capturing heterogeneity in gene expression studies by surrogate variable analysis. PLoS Genet. 2007 Sep 7;3(9):1724-35. Epub 2007 Aug 1.

Responsible Party: Massachusetts General Hospital ( Ronald G. Tompkins, Principal Investigator )
Study ID Numbers: 2 U54 GM062119_trauma, NIH 2 U54 GM062119
Study First Received: November 18, 2005
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00257231     History of Changes
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

Study placed in the following topic categories:
Burns
Shock
Multiple Organ Failure
Wounds and Injuries
Inflammation

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

ClinicalTrials.gov processed this record on July 06, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services