Clinical Evaluation of the i-STAT TBI Test

NCT04171960 | Completed FDA Device

• 1 other identifier: CS-2018-0009
• Study Type: observational
• Target: 1,106
• Locations: 1 country
• Sites: 21

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.

Conditions

Traumatic Brain Injury

Keywords

i-STAT; Traumatic Brain Injury; Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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 intra-cranial lesions for each subject.

  Within 24 Hours of Traumatic Brain Injury (TBI)

• Clinical performance measurement of the i-STAT TBI Test.

  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).

  Within 24 hours of Traumatic Brain Injury (TBI)

Study Arms (1)

Acute Blood Biomarker Branch

Blood drawn within 12 hours or 12-24 hours following injury for i-STAT TBI Testing and in-person baseline outcome assessments.

Diagnostic Test: Blood draw; Other: Outcome assessments

Interventions

Blood draw DIAGNOSTIC_TEST

Venous whole blood collection within 12 hours and 12-24 hours following injury.

Acute Blood Biomarker Branch

Outcome assessments OTHER

Administered at baseline.

Acute Blood Biomarker Branch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Point of Care: lead
• United States Department of Defense: collaborator
• University of California, San Francisco: collaborator

Study Sites (21)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Craig Hospital

Englewood, Colorado, 80113, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Rehabilitation Hospital of Indiana

Carmel, Indiana, 46032, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas, Austin

Austin, Texas, 78701, United States

Location

University of Texas, South Western

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Sciences Center of Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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.

  PMID: 27018834 BACKGROUND

• 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.

  PMID: 30054151 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens retained for future research.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Blood Specimen Collection; Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Manish Gupta, MS, MBA

  Abbott Point of Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 21, 2019
• Study Start: July 31, 2020
• Primary Completion: June 26, 2023
• Study Completion: November 29, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (21)