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Inflammation and the Host Response to Injury (Trauma)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257231
First Posted: November 22, 2005
Last Update Posted: November 9, 2016
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.
Information provided by (Responsible Party):
Ronald G. Tompkins, Massachusetts General Hospital
  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 Ronald G. Tompkins, Massachusetts General Hospital:

Primary Outcome Measures:
  • Time to death [ Time Frame: Within 28 after trauma injury ]
  • Change in gene expression after trauma injury [ Time Frame: Up to 28 days after trauma injury ]
  • Number and types of complications [ Time Frame: Up to 28 days after trauma injury ]

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 2018
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

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.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
Massachusetts General Hospital
Investigators
Principal Investigator: Ronald G Tompkins, MD, ScD Massachusetts General Hospital/Shriners Burn Hospital - Boston
  More Information

Additional Information:
Publications:
Escobar GA, Cheng AM, Moore EE, Johnson JL, Tannahill C, Baker HV, Moldawer LL, Banerjee A. Stored packed red blood cell transfusion up-regulates inflammatory gene expression in circulating leukocytes. Ann Surg. 2007 Jul;246(1):129-34.
Russom A, Sethu P, Irimia D, Mindrinos MN, Calvano SE, Garcia I, Finnerty C, Tannahill C, Abouhamze A, Wilhelmy J, López MC, Baker HV, Herndon DN, Lowry SF, Maier RV, Davis RW, Moldawer LL, Tompkins RG, Toner M; Inflammation and Host Response to Injury Large Scale Collaborative Research Program. Microfluidic leukocyte isolation for gene expression analysis in critically ill hospitalized patients. Clin Chem. 2008 May;54(5):891-900. doi: 10.1373/clinchem.2007.099150. Epub 2008 Mar 28.
Sperry JL, Frankel HL, Nathens AB, O'keefe GE, Cuschieri J, Moore EE, Maier RV, Minei JP; Inflammation and the Host Response to Injury Investigators. Characterization of persistent hyperglycemia: what does it mean postinjury? J Trauma. 2009 Apr;66(4):1076-82. doi: 10.1097/TA.0b013e31817db0de.
Hayden D, Lazar P, Schoenfeld D; Inflammation and the Host Response to Injury Investigators. Assessing statistical significance in microarray experiments using the distance between microarrays. PLoS One. 2009 Jun 16;4(6):e5838. doi: 10.1371/journal.pone.0005838.
Warren HS, Elson CM, Hayden DL, Schoenfeld DA, Cobb JP, Maier RV, Moldawer LL, Moore EE, Harbrecht BG, Pelak K, Cuschieri J, Herndon DN, Jeschke MG, Finnerty CC, Brownstein BH, Hennessy L, Mason PH, Tompkins RG; Inflammation and Host Response to Injury Large Scale Collaborative Research Program. A genomic score prognostic of outcome in trauma patients. Mol Med. 2009 Jul-Aug;15(7-8):220-7. doi: 10.2119/molmed.2009.00027. Epub 2009 Apr 10.
Rajicic N, Finkelstein DM, Schoenfeld DA; Inflammation and Host Response to Injury Research Program Investigators. Analysis of the relationship between longitudinal gene expressions and ordered categorical event data. Stat Med. 2009 Sep 30;28(22):2817-32. doi: 10.1002/sim.3665.
Cobb JP, Moore EE, Hayden DL, Minei JP, Cuschieri J, Yang J, Li Q, Lin N, Brownstein BH, Hennessy L, Mason PH, Schierding WS, Dixon DJ, Tompkins RG, Warren HS, Schoenfeld DA, Maier RV. Validation of the riboleukogram to detect ventilator-associated pneumonia after severe injury. Ann Surg. 2009 Oct;250(4):531-9. doi: 10.1097/SLA.0b013e3181b8fbd5. Review.
Neal MD, Cushieri J, Rosengart MR, Alarcon LH, Moore EE, Maier RV, Minei JP, Billiar TR, Peitzman AB, Sperry JL; Inflammation and Host Response to Injury Investigators. Preinjury statin use is associated with a higher risk of multiple organ failure after injury: a propensity score adjusted analysis. J Trauma. 2009 Sep;67(3):476-82; discussion 482-4. doi: 10.1097/TA.0b013e3181ad66bb.
Irimia D, Mindrinos M, Russom A, Xiao W, Wilhelmy J, Wang S, Heath JD, Kurn N, Tompkins RG, Davis RW, Toner M. Genome-wide transcriptome analysis of 150 cell samples. Integr Biol (Camb). 2009 Jan;1(1):99-107. doi: 10.1039/b814329c. Epub 2008 Nov 12.
Kotz KT, Xiao W, Miller-Graziano C, Qian WJ, Russom A, Warner EA, Moldawer LL, De A, Bankey PE, Petritis BO, Camp DG 2nd, Rosenbach AE, Goverman J, Fagan SP, Brownstein BH, Irimia D, Xu W, Wilhelmy J, Mindrinos MN, Smith RD, Davis RW, Tompkins RG, Toner M; Inflammation and the Host Response to Injury Collaborative Research Program. Clinical microfluidics for neutrophil genomics and proteomics. Nat Med. 2010 Sep;16(9):1042-7. doi: 10.1038/nm.2205. Epub 2010 Aug 29.
Xu W, Seok J, Mindrinos MN, Schweitzer AC, Jiang H, Wilhelmy J, Clark TA, Kapur K, Xing Y, Faham M, Storey JD, Moldawer LL, Maier RV, Tompkins RG, Wong WH, Davis RW, Xiao W; Inflammation and Host Response to Injury Large-Scale Collaborative Research Program. Human transcriptome array for high-throughput clinical studies. Proc Natl Acad Sci U S A. 2011 Mar 1;108(9):3707-12. doi: 10.1073/pnas.1019753108. Epub 2011 Feb 11.
Minei JP, Cuschieri J, Sperry J, Moore EE, West MA, Harbrecht BG, O'Keefe GE, Cohen MJ, Moldawer LL, Tompkins RG, Maier RV; Inflammation and the Host Response to Injury Collaborative Research Program. The changing pattern and implications of multiple organ failure after blunt injury with hemorrhagic shock. Crit Care Med. 2012 Apr;40(4):1129-35. doi: 10.1097/CCM.0b013e3182376e9f.
Xiao W, Mindrinos MN, Seok J, Cuschieri J, Cuenca AG, Gao H, Hayden DL, Hennessy L, Moore EE, Minei JP, Bankey PE, Johnson JL, Sperry J, Nathens AB, Billiar TR, West MA, Brownstein BH, Mason PH, Baker HV, Finnerty CC, Jeschke MG, López MC, Klein MB, Gamelli RL, Gibran NS, Arnoldo B, Xu W, Zhang Y, Calvano SE, McDonald-Smith GP, Schoenfeld DA, Storey JD, Cobb JP, Warren HS, Moldawer LL, Herndon DN, Lowry SF, Maier RV, Davis RW, Tompkins RG; Inflammation and Host Response to Injury Large-Scale Collaborative Research Program. A genomic storm in critically injured humans. J Exp Med. 2011 Dec 19;208(13):2581-90. doi: 10.1084/jem.20111354. Epub 2011 Nov 21.
Cuschieri J, Johnson JL, Sperry J, West MA, Moore EE, Minei JP, Bankey PE, Nathens AB, Cuenca AG, Efron PA, Hennessy L, Xiao W, Mindrinos MN, McDonald-Smith GP, Mason PH, Billiar TR, Schoenfeld DA, Warren HS, Cobb JP, Moldawer LL, Davis RW, Maier RV, Tompkins RG; Inflammation and Host Response to Injury, Large Scale Collaborative Research Program. Benchmarking outcomes in the critically injured trauma patient and the effect of implementing standard operating procedures. Ann Surg. 2012 May;255(5):993-9. doi: 10.1097/SLA.0b013e31824f1ebc.
Desai KH, Tan CS, Leek JT, Maier RV, Tompkins RG, Storey JD; Inflammation and the Host Response to Injury Large-Scale Collaborative Research Program. Dissecting inflammatory complications in critically injured patients by within-patient gene expression changes: a longitudinal clinical genomics study. PLoS Med. 2011 Sep;8(9):e1001093. doi: 10.1371/journal.pmed.1001093. Epub 2011 Sep 13.
Warner EA, Kotz KT, Ungaro RF, Abouhamze AS, Lopez MC, Cuenca AG, Kelly-Scumpia KM, Moreno C, O'Malley KA, Lanz JD, Baker HV, Martin LC, Toner M, Tompkins RG, Efron PA, Moldawer LL. Microfluidics-based capture of human neutrophils for expression analysis in blood and bronchoalveolar lavage. Lab Invest. 2011 Dec;91(12):1787-95. doi: 10.1038/labinvest.2011.94. Epub 2011 Sep 19.
Seok J, Warren HS, Cuenca AG, Mindrinos MN, Baker HV, Xu W, Richards DR, McDonald-Smith GP, Gao H, Hennessy L, Finnerty CC, López CM, Honari S, Moore EE, Minei JP, Cuschieri J, Bankey PE, Johnson JL, Sperry J, Nathens AB, Billiar TR, West MA, Jeschke MG, Klein MB, Gamelli RL, Gibran NS, Brownstein BH, Miller-Graziano C, Calvano SE, Mason PH, Cobb JP, Rahme LG, Lowry SF, Maier RV, Moldawer LL, Herndon DN, Davis RW, Xiao W, Tompkins RG; Inflammation and Host Response to Injury, Large Scale Collaborative Research Program. Genomic responses in mouse models poorly mimic human inflammatory diseases. Proc Natl Acad Sci U S A. 2013 Feb 26;110(9):3507-12. doi: 10.1073/pnas.1222878110. Epub 2013 Feb 11.
Zhou JY, Krovvidi RK, Gao Y, Gao H, Petritis BO, De AK, Miller-Graziano CL, Bankey PE, Petyuk VA, Nicora CD, Clauss TR, Moore RJ, Shi T, Brown JN, Kaushal A, Xiao W, Davis RW, Maier RV, Tompkins RG, Qian WJ, Camp DG 2nd, Smith RD; Inflammation and the Host Response to Injury Large Scale Collaborative Research Program. Trauma-associated human neutrophil alterations revealed by comparative proteomics profiling. Proteomics Clin Appl. 2013 Aug;7(7-8):571-83. doi: 10.1002/prca.201200109. Epub 2013 May 22.
Cuenca AG, Gentile LF, Lopez MC, Ungaro R, Liu H, Xiao W, Seok J, Mindrinos MN, Ang D, Baslanti TO, Bihorac A, Efron PA, Cuschieri J, Warren HS, Tompkins RG, Maier RV, Baker HV, Moldawer LL; Inflammation and Host Response to Injury Collaborative Research Program. Development of a genomic metric that can be rapidly used to predict clinical outcome in severely injured trauma patients. Crit Care Med. 2013 May;41(5):1175-85. doi: 10.1097/CCM.0b013e318277131c.
Warren HS, Tompkins RG, Mindrinos MN, Xiao W, Davis RW. Reply to Cauwels et al.: Of men, not mice, and inflammation. Proc Natl Acad Sci U S A. 2013 Aug 20;110(34):E3151.
Tompkins RG, Warren HS, Mindrinos MN, Xiao W, Davis RW. Reply to Osterburg et al.: To study human inflammatory diseases in humans. Proc Natl Acad Sci U S A. 2013 Sep 3;110(36):E3371.
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. Erratum in: Nature. 2005 Dec 1;438(7068):696.
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, Tolié 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.
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.
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 Collaborative Research Program. 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. Erratum in: J Trauma. 2009 Mar;66(3):965.
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 Collaborative Research Program. 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. Erratum in: J Trauma. 2009 Mar;66(3):965.
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.
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.
Leek JT, Storey JD. Capturing heterogeneity in gene expression studies by surrogate variable analysis. PLoS Genet. 2007 Sep;3(9):1724-35. Epub 2007 Aug 1.
Lederer JA, Brownstein BH, Lopez MC, Macmillan S, Delisle AJ, Macconmara MP, Choudhry MA, Xiao W, Lekousi S, Cobb JP, Baker HV, Mannick JA, Chaudry IH; Inflammation and the Host Response to Injury Collaborative Research Program Participants. Comparison of longitudinal leukocyte gene expression after burn injury or trauma-hemorrhage in mice. Physiol Genomics. 2008 Feb 19;32(3):299-310. Epub 2007 Nov 6.
Harbrecht BG, Minei JP, Shapiro MB, Nathens AB, Moore EE, West MA, Bankey PE, Cuschieri J, Johnson JL, Maier RV; Inflammation and the Host Response to Injury Scale Collaborative Research Project. Inflammation and the host response to injury, a large-scale collaborative project: patient-oriented research core-standard operating procedures for clinical care: VI. Blood glucose control in the critically ill trauma patient. J Trauma. 2007 Sep;63(3):703-8.
Shapiro MB, West MA, Nathens AB, Harbrecht BG, Moore FA, Bankey PE, Freeman B, Johnson JL, McKinley BA, Minei JP, Moore EE, Maier RV; Inflammation and the Host Response to Injury Large Scale Collaborative Research Project. V. Guidelines for sedation and analgesia during mechanical ventilation general overview. J Trauma. 2007 Oct;63(4):945-50. Review.
Polpitiya AD, Qian WJ, Jaitly N, Petyuk VA, Adkins JN, Camp DG 2nd, Anderson GA, Smith RD. DAnTE: a statistical tool for quantitative analysis of -omics data. Bioinformatics. 2008 Jul 1;24(13):1556-8. doi: 10.1093/bioinformatics/btn217. Epub 2008 May 3.
Cuschieri J, Freeman B, O'Keefe G, Harbrecht BG, Bankey P, Johnson JL, Minei JP, Sperry J, West M, Nathens A, Moore EE, Maier RV; Inflammation and the Host Response to Injury Collaborative Research Program. Inflammation and the host response to injury a large-scale collaborative project: patient-oriented research core standard operating procedure for clinical care X. Guidelines for venous thromboembolism prophylaxis in the trauma patient. J Trauma. 2008 Oct;65(4):944-50. doi: 10.1097/TA.0b013e3181826df7. Review. Erratum in: J Trauma. 2009 Mar;66(3):965.
O'Keefe GE, Shelton M, Cuschieri J, Moore EE, Lowry SF, Harbrecht BG, Maier RV; Inflammation and the Host Response to Injury Collaborative Research Program. Inflammation and the host response to injury, a large-scale collaborative project: patient-oriented research core--standard operating procedures for clinical care VIII--Nutritional support of the trauma patient. J Trauma. 2008 Dec;65(6):1520-8. doi: 10.1097/TA.0b013e3181904b0c. Erratum in: J Trauma. 2009 Mar;66(3):965.
West MA, Moore EE, Shapiro MB, Nathens AB, Cuschieri J, Johnson JL, Harbrecht BG, Minei JP, Bankey PE, Maier RV; Inflammation and the Host Response to Injury Collaborative Research Program. Inflammation and the host response to injury, a large-scale collaborative project: patient-oriented research core--standard operating procedures for clinical care VII--Guidelines for antibiotic administration in severely injured patients. J Trauma. 2008 Dec;65(6):1511-9. doi: 10.1097/TA.0b013e318184ee35.
Evans HL, Cuschieri J, Moore EE, Shapiro MB, Nathens AB, Johnson JL, Harbrecht BG, Minei JP, Bankey PE, Maier RV, West MA; Inflammation and 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 IX. Definitions for complications of clinical care of critically injured patients. J Trauma. 2009 Aug;67(2):384-8. doi: 10.1097/TA.0b013e3181ad66a7.
Warren HS, Tompkins RG, Moldawer LL, Seok J, Xu W, Mindrinos MN, Maier RV, Xiao W, Davis RW. Mice are not men. Proc Natl Acad Sci U S A. 2015 Jan 27;112(4):E345. doi: 10.1073/pnas.1414857111. Epub 2014 Dec 24.

Responsible Party: Ronald G. Tompkins, Chief, Burns Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00257231     History of Changes
Other Study ID Numbers: 2 U54 GM062119_trauma
U54GM062119 ( U.S. NIH Grant/Contract )
First Submitted: November 18, 2005
First Posted: November 22, 2005
Last Update Posted: November 9, 2016
Last Verified: November 2016
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
Inflammation
Genomics
Proteomics

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


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