Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1106 participants
OBSERVATIONAL
2020-07-31
2023-11-29
Brief Summary
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Patients will be asked to provide a blood sample.
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Detailed Description
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The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acute Blood Biomarker Branch
Blood drawn within 12 hours or 12-24 hours following injury for i-STAT TBI Testing and in-person baseline outcome assessments.
Blood draw
Venous whole blood collection within 12 hours and 12-24 hours following injury.
Outcome assessments
Administered at baseline.
Interventions
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Blood draw
Venous whole blood collection within 12 hours and 12-24 hours following injury.
Outcome assessments
Administered at baseline.
Eligibility Criteria
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Inclusion Criteria
2. Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
3. Subject presented to a health care facility or emergency department with a suspected TBI resulting from an insult to the head by an external force within 12 hours of the injury.
4. Subject has a CT scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility or are transferred to the enrolling facility with a head CT scan sent from the originating facility.
5. As a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following.
1. Any period of loss of consciousness
2. Any loss of memory for events immediately before or after the injury
3. Any alteration of mental state at the time of the injury
4. Focal neurological deficits that may or may not be transient
Exclusion Criteria
2. Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
3. Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
4. Time of injury is unknown and cannot be estimated
5. Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association \[ASIA\] score of C or worse) at the enrolling facility
6. Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge
7. Prisoners or patients in custody
8. Patients on psychiatric hold
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of California, San Francisco
OTHER
Abbott Point of Care
INDUSTRY
Responsible Party
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Principal Investigators
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Manish Gupta, MS, MBA
Role: STUDY_DIRECTOR
Abbott Point of Care
Locations
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University of California, San Francisco
San Francisco, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Craig Hospital
Englewood, Colorado, United States
University of Miami
Miami, Florida, United States
Rehabilitation Hospital of Indiana
Carmel, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
University of Texas, Austin
Austin, Texas, United States
University of Texas, South Western
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Sciences Center of Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Papa L, Brophy GM, Welch RD, Lewis LM, Braga CF, Tan CN, Ameli NJ, Lopez MA, Haeussler CA, Mendez Giordano DI, Silvestri S, Giordano P, Weber KD, Hill-Pryor C, Hack DC. Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury. JAMA Neurol. 2016 May 1;73(5):551-60. doi: 10.1001/jamaneurol.2016.0039.
Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Buki A, Chen JY, Christenson RH, Hack D, Huff JS, Johar S, Jordan JD, Leidel BA, Lindner T, Ludington E, Okonkwo DO, Ornato J, Peacock WF, Schmidt K, Tyndall JA, Vossough A, Jagoda AS. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018 Sep;17(9):782-789. doi: 10.1016/S1474-4422(18)30231-X. Epub 2018 Jul 24.
Other Identifiers
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CS-2018-0009
Identifier Type: -
Identifier Source: org_study_id
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