Skip to content

Inflammation and the Host Response to Injury (Trauma)

Inflammation and the Host Response to Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00257231
Enrollment
610
Registered
2005-11-22
Start date
2003-11-30
Completion date
2018-09-30
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Multiple Organ Failure, Trauma

Keywords

Immunity, innate, Inflammation, Genomics, Proteomics

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to deathWithin 28 after trauma injury
Change in gene expression after trauma injuryUp to 28 days after trauma injury
Number and types of complicationsUp to 28 days after trauma injury

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026