An observational study in Trauma, Burns and Multiple Organ Failure, sponsored by Massachusetts General Hospital. Completed at 4 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Massachusetts General Hospital · Observational
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.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 610 is above the median of 95 across 895 observational studies indexed under Inflammation.
Browse Inflammation studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Acute hospitalized blunt trauma patients
Inclusion criteria for enrollment in the trauma study are as follows:
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.
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
Plan to share: Yes — Curated and validated data are available to Consortium Members
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital