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: Active, not recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Diagnostic test: Blood draw; Other: Outcome assessments; Diagnostic test: MRI

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: Observational
• Enrollment (Actual): 1106

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority
    • Englewood, Colorado, United States, 80113
      • Craig Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Rehabilitation Hospital of Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Presbyterian Hospital
  • Texas
    • Austin, Texas, United States, 78701
      • University of Texas, Austin
    • Dallas, Texas, United States, 75390
      • University of Texas, South Western
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • University of Texas Health Sciences Center of Houston
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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:

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Blood Biomarker Branch; Blood draw within 12 hours or 12-24 hours following injury for i-STAT Testing and in-person outcome assessments.	Diagnostic test: Blood draw; Blood collection within 12 hours, 12-24 hours, 2 weeks, and 6 months following injury.; Other: Outcome assessments; Administered at baseline, 2 and 6 weeks, 3 and 6 months following injury.
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.	Diagnostic test: Blood draw; Blood collection within 12 hours, 12-24 hours, 2 weeks, and 6 months following injury.; Other: Outcome assessments; Administered at baseline, 2 and 6 weeks, 3 and 6 months following injury.; Diagnostic test: MRI; 3T Magnetic Resonance Imaging

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.	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)
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 Outcome Measures

Outcome Measure	Time Frame
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI)	2-Weeks and 6-Months following Traumatic Brain Injury (TBI)
Blood Specimens for Analysis of Biomarkers and Genetics	12-24 Hours, 2-Weeks, and 6-Months following Traumatic Brain Injury (TBI)
Baseline Outcome Assessment (Composite Measure)	At baseline following Traumatic Brain Injury (TBI)
Follow-Up Outcome Assessment (Composite Measure)	2-Weeks, 6-Weeks, 3-Months, and 6-Months following Traumatic Brain Injury (TBI)

Collaborators and Investigators

• Sponsor: Abbott Point of Care
• Collaborators: United States Department of Defense; University of California, San Francisco
• 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): July 30, 2020
• Primary Completion (Actual): November 10, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Biomarkers; Traumatic Brain Injury; i-STAT
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: CS-2018-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan is currently undecided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No