Inflammation and the Host Response to Injury (Trauma)

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00257231

Collaborator

(none)

610

Enrollment

Locations

178

Duration (Months)

152.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Burns Multiple Organ Failure

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

610 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Inflammation and the Host Response to Injury

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2018

Outcome Measures

Primary Outcome Measures

Time to death [Within 28 after trauma injury]
Change in gene expression after trauma injury [Up to 28 days after trauma injury]
Number and types of complications [Up to 28 days after trauma injury]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Significant pre-existing organ dysfunction - liver: cirrhosis with portal hypertension or encephalopathy
Patient injured while sampling enrollment temporarily on hold

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver Health Medical Center at University of Colorado	Denver	Colorado	United States	80204
2	Presbyterian University Hospital at University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
3	Southwestern Medical Center at University of Texas Southwestern	Dallas	Texas	United States	75390
4	Harborview Medical Center	Seattle	Washington	United States	98104