- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171960
Clinical Evaluation of the i-STAT TBI Test
The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).
Patients will be asked to provide a blood sample.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a computed tomography (CT) scan in patients presenting with suspected mild traumatic brain injury (TBI) who are 18 years of age or older.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80204
- Denver Health and Hospital Authority
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Englewood, Colorado, United States, 80113
- Craig Hospital
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Indiana
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Carmel, Indiana, United States, 46032
- Rehabilitation Hospital of Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University School of Medicine
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center Presbyterian Hospital
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Texas
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Austin, Texas, United States, 78701
- University of Texas, Austin
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Dallas, Texas, United States, 75390
- University of Texas, South Western
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Houston, Texas, United States, 77030
- University of Texas Health Sciences Center of Houston
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Washington
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Seattle, Washington, United States, 98104
- University of Washington
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
We will enroll patients presenting to the Healthcare Facility patients with suspected mild TBI* who are 18 years of age or older, have a GCS score of 13-15 and present within 24 hours of injury.
* Mild TBI includes the head being struck or striking an object, or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head.
Description
Acute Blood Biomarker Branch Subject Inclusion Criteria:
- 18 years of age or older.
- Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
- 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.
- 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.
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.
- Any period of loss of consciousness
- Any loss of memory for events immediately before or after the injury
- Any alteration of mental state at the time of the injury
- Focal neurological deficits that may or may not be transient
Acute Blood Biomarker Branch Subject Exclusion Criteria.
- Previous enrollment in this study
- Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
- Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
- Time of injury is unknown and cannot be estimated
- Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association [ASIA] score of C or worse) at the enrolling facility
- Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge
- Prisoners or patients in custody
- Patients on psychiatric hold
Follow-up Branch Subject Inclusion Criteria.
- Enrollment in Acute Blood Biomarker Branch
- Subject or LAR provided informed consent for the Acute Blood Biomarker Branch and the Follow-up Branch
Follow up Branch Subject Exclusion Criteria.
1. Conditions or circumstances that would interfere with follow-up and outcome assessment, as determined by the principal investigator or delegate. Examples include.
- Significant polytrauma
- Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder)
- Major debilitating neurological disease (e.g. stroke, cerebrovascular accident, dementia, tumor)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Acute Blood Biomarker Branch
Blood draw within 12 hours or 12-24 hours following injury for i-STAT Testing and in-person outcome assessments.
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Blood collection within 12 hours, 12-24 hours, 2 weeks, and 6 months following injury.
Administered at baseline, 2 and 6 weeks, 3 and 6 months following injury.
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Acute Blood Biomarker Plus Follow-up Branch
Blood draw and 3T Magnetic Resonance Imaging (MRI) at 2 weeks and 6 months following injury, in-person and phone outcome assessments.
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Blood collection within 12 hours, 12-24 hours, 2 weeks, and 6 months following injury.
Administered at baseline, 2 and 6 weeks, 3 and 6 months following injury.
3T Magnetic Resonance Imaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings.
Time Frame: Within 12 Hours of Traumatic Brain Injury (TBI)
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Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings for each subject.
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Within 12 Hours of Traumatic Brain Injury (TBI)
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Clinical sensitivity, clinical specificity, negative predictive value (NPV) and positive predictive value (PPV) of the i-STAT TBI Test
Time Frame: Within 12 hours of Traumatic Brain Injury (TBI)
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Within 12 hours of Traumatic Brain Injury (TBI)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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3T Brain Structural and Functional Magnetic Resonance Imaging (MRI)
Time Frame: 2-Weeks and 6-Months following Traumatic Brain Injury (TBI)
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2-Weeks and 6-Months following Traumatic Brain Injury (TBI)
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Blood Specimens for Analysis of Biomarkers and Genetics
Time Frame: 12-24 Hours, 2-Weeks, and 6-Months following Traumatic Brain Injury (TBI)
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12-24 Hours, 2-Weeks, and 6-Months following Traumatic Brain Injury (TBI)
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Baseline Outcome Assessment (Composite Measure)
Time Frame: At baseline following Traumatic Brain Injury (TBI)
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At baseline following Traumatic Brain Injury (TBI)
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Follow-Up Outcome Assessment (Composite Measure)
Time Frame: 2-Weeks, 6-Weeks, 3-Months, and 6-Months following Traumatic Brain Injury (TBI)
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2-Weeks, 6-Weeks, 3-Months, and 6-Months following Traumatic Brain Injury (TBI)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Manish Gupta, MS, MBA, Abbott Point of Care
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS-2018-0009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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