Status:
UNKNOWN
Mathematical Modeling of the Acute Inflammatory Response Following Injury
Lead Sponsor:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Trauma
Critical Illness
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research study is to gather clinical and biologic information from severely injured patients to better understand and characterize the host response to injury and inflammation acro...
Eligibility Criteria
Inclusion
- Trauma patient cohort inclusion criteria:
- Present for treatment of their acute, blunt or penetrating injuries to the University of Pittsburgh Medical Center within 6 hours of injury
- Age greater than or equal to 18 years
- Intact cervical spinal cord
- Are admitted to the Intensive Care Unit
- Trauma patient cohort exclusion criteria:
- Anticipated survival \< 24 hrs
- Anticipated survival \< 28 days due to pre-existing condition
- Traumatic Brain injury (GCS ≤8 after ICU admission) AND brain CT abnormality within 12 hr of injury
- Inability to obtain consent from the subject or their legally authorized representative.
- Pre-existing immunosuppression
- Transplant recipient
- Chronic high doses of steroids (\>20 mg prednisone equivalents/day)
- Significant likelihood of high dose steroids (e.g. spinal cord injury)
- Oncolytic drug(s) therapy within the past 14 days
- Known HIV positive status and CD4 count \< 200 cells/mm3
- Admission to the ICU primary for substance withdrawal.
- Inability to obtain 1st blood sample within 24 hours of injury.
- Healthy volunteer cohort inclusion:
- Age greater than or equal to 18 years
- Weight \> 110 pounds
- no recent illness or infection in the last two weeks
- no recent hospitalization or trauma in the last month
- Healthy volunteer cohort exclusion:
- wt \< 110 lbs
- infection or illness in the last two weeks
- Hospitalization or trauma in the last month
Exclusion
Key Trial Info
Start Date :
February 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00250523
Start Date
February 1 2003
End Date
July 1 2022
Last Update
March 2 2021
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213