Clinical Evaluation of the i-STAT TBI Test

Traumatic Brain Injury Clinical Trial

Official title:

Clinical Evaluation of the i-STAT TBI Test

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04171960
• Other study ID #: CS-2018-0009
• Status: Active, not recruiting
• Start date: July 30, 2020
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Abbott Point of Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1106
• Est. completion date: May 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Acute Blood Biomarker Branch Subject Inclusion Criteria:

1. 18 years of age or older.

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

Acute Blood Biomarker Branch Subject Exclusion Criteria.

1. Previous enrollment in this study

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

Follow-up Branch Subject Inclusion Criteria.

1. Enrollment in Acute Blood Biomarker Branch

2. 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.

1. Significant polytrauma

2. Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder)

3. Major debilitating neurological disease (e.g. stroke, cerebrovascular accident, dementia, tumor)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Diagnostic Test:
• Blood draw
Blood collection within 12 hours, 12-24 hours, 2 weeks, and 6 months following injury.
• MRI
3T Magnetic Resonance Imaging

Other:
• Outcome assessments
Administered at baseline, 2 and 6 weeks, 3 and 6 months following injury.

Locations

Country	Name	City	State
United States	University of Texas, Austin	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rehabilitation Hospital of Indiana	Carmel	Indiana
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Texas, South Western	Dallas	Texas
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Craig Hospital	Englewood	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas Health Sciences Center of Houston	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Kentucky	Lexington	Kentucky
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Point of Care	United States Department of Defense, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings.	Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings for each subject.	Within 12 Hours of Traumatic Brain Injury (TBI)
Primary	Clinical sensitivity, clinical specificity, negative predictive value (NPV) and positive predictive value (PPV) of the i-STAT TBI Test		Within 12 hours of Traumatic Brain Injury (TBI)
Secondary	3T Brain Structural and Functional Magnetic Resonance Imaging (MRI)		2-Weeks and 6-Months following Traumatic Brain Injury (TBI)
Secondary	Blood Specimens for Analysis of Biomarkers and Genetics		12-24 Hours, 2-Weeks, and 6-Months following Traumatic Brain Injury (TBI)
Secondary	Baseline Outcome Assessment (Composite Measure)		At baseline following Traumatic Brain Injury (TBI)
Secondary	Follow-Up Outcome Assessment (Composite Measure)		2-Weeks, 6-Weeks, 3-Months, and 6-Months following Traumatic Brain Injury (TBI)