Inflammation and the Host Response to Injury (Trauma)

Trauma Clinical Trial

Official title:

Inflammation and the Host Response to Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257231
• Other study ID #: 2 U54 GM062119_trauma
• Secondary ID: U54GM062119
• Status: Completed
• Start date: November 2003
• Est. completion date: September 2018

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: September 2018
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Inflammation
• Multiple Organ Failure
• Trauma

Locations

Country	Name	City	State
United States	Southwestern Medical Center at University of Texas Southwestern	Dallas	Texas
United States	Denver Health Medical Center at University of Colorado	Denver	Colorado
United States	Presbyterian University Hospital at University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (57)

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. — View Citation

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. — View Citation

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. — View Citation

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 pneumo — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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, Tomp — View Citation

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. — View Citation

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 ch — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.0 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 orga — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 La — View Citation

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, — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Siddiqui J, Remick DG. Improved sensitivity of colorimetric compared to chemiluminescence ELISAs for cytokine assays. J Immunoassay Immunochem. 2003;24(3):273-83. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Toner M, Irimia D. Blood-on-a-chip. Annu Rev Biomed Eng. 2005;7:77-103. Review. — View Citation

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 — View Citation

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 La — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Gamel — View Citation

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 Progr — View Citation

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 Hos — View Citation

* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death		Within 28 after trauma injury
Primary	Change in gene expression after trauma injury		Up to 28 days after trauma injury
Primary	Number and types of complications		Up to 28 days after trauma injury

External Links

•   Information about the study and its goals. Contains links to study related publications, resources, and participating institutions