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Status:

COMPLETED

Inflammation and the Host Response to Injury (Trauma)

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Trauma

Burns

Eligibility:

All Genders

16+ years

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...

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 tec...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2018

    Estimated Enrollment :

    610 Patients enrolled

    Trial Details

    Trial ID

    NCT00257231

    Start Date

    November 1 2003

    End Date

    September 1 2018

    Last Update

    March 7 2019

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    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