Clinical trial NCT04171960: Clinical Evaluation of the i-STAT TBI Test
Official title: Clinical Evaluation of the i-STAT TBI Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: i-STAT
Traumatic Brain Injury
Biomarkers
Lead sponsor: Abbott Point of Care
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
name: University of California, San Francisco
First posted: 2019-11-21
Enrollment: 1106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consisted of patients who are 18 years of age or older presenting to the Healthcare Facility with suspected mild TBI\*, a GCS score of 13-15 and within 24 hours of head injury.

\*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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings.
timeFrame: Within 24 Hours of Traumatic Brain Injury (TBI)
measure: Clinical performance measurement of the i-STAT TBI Test.
timeFrame: Within 24 hours of Traumatic Brain Injury (TBI)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Carmel
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian Hospital
state: Pennsylvania
city: Austin
country: United States
facility: University of Texas, Austin
state: Texas
city: Dallas
country: United States
facility: University of Texas, South Western
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas Health Sciences Center of Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Abbott Point of Care
name: Manish Gupta, MS, MBA
role: STUDY_DIRECTOR
References:
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.
citation: 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.