Status:
COMPLETED
A Validation of a Genomics Based Prognostic in Severe Trauma
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Trauma; Complications
Multiple Organ Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to learn more about how to treat patients with severe injuries related to trauma and to prevent failure of vital organs in this patient population. Approximately 200 sever...
Detailed Description
Specific Aim: To prospectively validate a rapid genomic test obtained from blood leukocyte subpopulation of severely traumatized patients in the first 24 hours after admission, that can be used to dis...
Eligibility Criteria
Inclusion
- Inclusion Criteria Trauma Patients:
- All adults (age ≥18)
- Blunt trauma patients with hemorrhagic shock, defined by either a systolic BP (SBP) \<90 mm Hg or base deficit (BD) \<-6 meq
- Ability to obtain Informed Consent within 96 hours of injury.
- Ability to obtain the first lab draw within 12 hours of presentation to the Emergency Department.
- Exclusion Criteria Trauma Patients:
- Patients not expected to survive greater than 48 hours.
- Patients with severe head injury.
- Severe pre-existing organ dysfunction
- Those that we are unable to obtain the first blood sample within 12 hours of injury
- Subjects who have received oncolytics within 14 days
- Subjects who are HIV + and have a CD4 count of \<200/mm3
- Subjects not expected to survive 28 days due to pre-existing, uncorrectable medical condition
- Total body surface burns \>40%
- Prisoners
- Current, chronic steroid use
- If it is uncertain what the patient's past medical history is at the time of enrollment, they can be enrolled in the study and subsequently removed if they fail to meet criteria. This will be done because there are many circumstances with this patient population due to the severity of the injuries, the vulnerable nature of the patient at this early time, and the challenge in reaching the patient's legal representatives that we are unaware of their past medical history. The purpose of these exclusions is to ensure an adequate allocation of resources. Specifically, our goal is to evaluate patients at high risk for Multiple Organ Dysfunction Syndrome (MODS). Those with anticipated early death will add little to achieving this objective. Severe head injuries are excluded as well since the mortality in these subjects is usually attributable to their head injury rather than severe organ dysfunction. In addition, steroid use is known to affect the immunologic response to injury.
- Inclusion Criteria Healthy Volunteers:
- all adults (age ≥18)
- Ability to obtain Informed Consent prior to blood collection.
- Exclusion Criteria Healthy Volunteers:
- Severe pre-existing organ dysfunction
- Subjects who have received oncolytics within 14 days
- Subjects who are HIV + and have a CD4 count of \<200/mm3
- Subjects not expected to survive 28 days due to pre-existing, uncorrectable medical condition
- Total body surface burns \>40%
- Prisoners
- Current, chronic steroid use
Exclusion
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01810328
Start Date
October 1 2013
End Date
July 23 2019
Last Update
July 24 2019
Active Locations (2)
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1
UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF
Gainesville, Florida, United States, 32610
2
UW Harborview Research and Training Building
Seattle, Washington, United States, 98104