Clinical Evaluation of the i-STAT TBI Test

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT04171960
• Lead Sponsor: Abbott Point of Care

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.

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-07-31
• Primary Completion: 2023-06-26
• Study Completion: 2023-11-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1106

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings.	Within 24 Hours of Traumatic Brain Injury (TBI)	Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings (+/-) for intra-cranial lesions for each subject.
Clinical performance measurement of the i-STAT TBI Test.	Within 24 hours of Traumatic Brain Injury (TBI)	Clinical performance metrics included, clinical sensitivity, clinical specificity, negative predictive value (NPV), positive predictive value (PPV), adjusted negative predictive value (adj. NPV) calculated to a 6% CT positive prevalence rate, negative likelihood ratio (neg. LR) and positive likelihood ratio (pos. LR).

Trial Locations

Locations (21)

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

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