Inflammation and the Host Response to Injury (Trauma)

NCT ID: NCT00257231

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 610 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2018-09-30

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.

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.

Conditions

Trauma; Burns; Multiple Organ Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ronald G. Tompkins

Chief, Burns Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald G Tompkins, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital/Shriners Burn Hospital - Boston

Locations

Denver Health Medical Center at University of Colorado

Denver, Colorado, United States

Presbyterian University Hospital at University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Southwestern Medical Center at University of Texas Southwestern

Dallas, Texas, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

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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. No abstract available.

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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. doi: 10.1097/01.sla.0000264507.79859.f9.

Reference Type: RESULT

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Russom A, Sethu P, Irimia D, Mindrinos MN, Calvano SE, Garcia I, Finnerty C, Tannahill C, Abouhamze A, Wilhelmy J, Lopez 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.

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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.

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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.

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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.

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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.

Reference Type: RESULT

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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.

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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.

Reference Type: RESULT

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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.

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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.

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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.

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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.

Reference Type: RESULT

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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, Lopez 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.

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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.

Reference Type: RESULT

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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.

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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.

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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. doi: 10.1073/pnas.1307452110. No abstract available.

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Other Identifiers

U54GM062119

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2 U54 GM062119_trauma

Identifier Type: -

Identifier Source: org_study_id