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TraumaNCT00257231

Inflammation and the Host Response to Injury (Trauma)

An observational study of Trauma and Burns, run by Massachusetts General Hospital at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Trauma, Burns, Multiple Organ Failure
How many people
610 participants
Where
4 sitesUnited States
Study dates
Nov 2003to Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Acute hospitalized blunt trauma patients

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Southwestern Medical Center at University of Texas Southwestern

    Dallas, Texas, 75390

  • Denver Health Medical Center at University of Colorado

    Denver, Colorado, 80204

  • Presbyterian University Hospital at University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Inflammation and the Host Response to Injury

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.

Read the 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.

Keywords
Immunity, innate, Inflammation, Genomics, Proteomics
Medical subject headings
Wounds and Injuries, Burns, Multiple Organ Failure, Inflammation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to death

    Measured: Within 28 after trauma injury

  2. Change in gene expression after trauma injury

    Measured: Up to 28 days after trauma injury

  3. Number and types of complications

    Measured: Up to 28 days after trauma injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2005 (estimated)
  2. Study startNov 2003
  3. Primary completionSep 2013
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
610 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257231
Sponsor's protocol ID
2 U54 GM062119_trauma
Other IDs
U54GM062119
Status last verified
Mar 2019
First submitted
18 Nov 2005
Last updated
7 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Curated and validated data are available to Consortium Members

Publications

  • Siddiqui J, Remick DG. Improved sensitivity of colorimetric compared to chemiluminescence ELISAs for cytokine assays. J Immunoassay Immunochem. 2003;24(3):273-83. doi: 10.1081/IAS-120022937.

    PubMed 12953972

  • 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. doi: 10.1021/ac034869m.

    PubMed 14961748

  • 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. doi: 10.1021/ac0497508.

    PubMed 15481964

  • 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. doi: 10.1021/ac049429p.

    PubMed 15516115

  • 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. doi: 10.1152/physiolgenomics.00020.2004.

    PubMed 15548831

  • 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. doi: 10.1021/la048047b.

    PubMed 15595794

  • 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. doi: 10.1002/pmic.200400942.

    PubMed 15627965

  • 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. doi: 10.1128/CDLI.12.1.60-67.2005.

    PubMed 15642986

  • 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. doi: 10.1074/mcp.M500045-MCP200. Epub 2005 Mar 7.

    PubMed 15753121

  • 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. doi: 10.1073/pnas.0409768102. Epub 2005 Mar 21.

    PubMed 15781863

  • Toner M, Irimia D. Blood-on-a-chip. Annu Rev Biomed Eng. 2005;7:77-103. doi: 10.1146/annurev.bioeng.7.011205.135108.

    PubMed 16004567

  • 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. doi: 10.1038/nature03985. Epub 2005 Aug 31.

    PubMed 16136080

  • 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. doi: 10.1073/pnas.0504609102. Epub 2005 Sep 2.

    PubMed 16141318

  • 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. doi: 10.1002/pmic.200401246.

    PubMed 16152657

  • 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. doi: 10.4049/jimmunol.175.9.6155.

    PubMed 16237112

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma and Burns, run by Massachusetts General Hospital at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to death (time frame: Within 28 after trauma injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257231, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.

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