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Clinical Evaluation of the i-STAT TBI Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171960
Recruitment Status : Enrolling by invitation
First Posted : November 21, 2019
Last Update Posted : August 8, 2022
Sponsor:
Collaborators:
United States Department of Defense
University of California, San Francisco
Information provided by (Responsible Party):
Abbott Point of Care

Brief Summary:
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 CT scan in patients presenting with suspected mild traumatic brain injury 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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Other: Blood Draw Within 12 Hours of Injury Other: 3T MRI Other: In-Person Outcome Assessment at Baseline Other: In-Person Outcome Assessment at Follow-Up Other: Phone Outcome Assessment Other: Blood Draw After 12 Hours of Injury

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of the i-STAT TBI Test
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute Blood Biomarker Branch
  • Blood draw within 12 hours of injury for i-STAT Testing then processing for storage for future use
  • Blood draw between 12 to 24 hours of injury then processing for storage for future use
  • In-Person Outcome Assessment
Other: Blood Draw Within 12 Hours of Injury
- Specimens collected for i-STAT testing and, if applicable, for optional collection of DNA for possible future genetic testing.

Other: In-Person Outcome Assessment at Baseline
-3 Outcome Assessments administered at Baseline.

Other: Blood Draw After 12 Hours of Injury
- Specimens collected at 12-24 hours, 2 weeks, and 6 month following injury then processed for storage for future use.

Acute Blood Biomarker Plus Follow-up Branch
  • Blood draw at 2 weeks and 6 months following injury then processing for storage for future use
  • In-Person Outcome Assessment at 2 weeks, 6 weeks, and 6 months following injury
  • Phone Outcome Assessment at 3 months following injury
  • 3T Magnetic Resonance Imaging (MRI) at 2 weeks and 6 months following injury
Other: 3T MRI
- 3T Magnetic Resonance Imaging (MRI) at 2 weeks and 6 months following injury.

Other: In-Person Outcome Assessment at Baseline
-3 Outcome Assessments administered at Baseline.

Other: In-Person Outcome Assessment at Follow-Up
- Full set of Outcome Assessment at 2 weeks, 6 weeks, and 6 months following injury.

Other: Phone Outcome Assessment
- 6 Outcome Assessments administered at 3 months following injury by Phone.

Other: Blood Draw After 12 Hours of Injury
- Specimens collected at 12-24 hours, 2 weeks, and 6 month following injury then processed for storage for future use.




Primary Outcome Measures :
  1. i-STAT TBI Test (elevated/not elevated) relative to standard of care Computed Tomography (CT) findings [ Time Frame: Within 12 Hours of Traumatic Brain Injury (TBI) ]
    Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings for each subject.

  2. Clinical sensitivity, clinical specificity, negative predictive value (NPV) and positive predictive value (PPV) of the i-STAT TBI Test [ Time Frame: 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.


Secondary Outcome Measures :
  1. 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) [ Time Frame: 2-Weeks and 6-Months following Traumatic Brain Injury (TBI) ]
    • Sagittal 3D T1 MP-RAGE/IR-SPGR
    • Sagittal 3D T2 GRE/SWAN/SWI
    • Axial DTI
    • Axial Resting State functional MRI (fMRI)
    • Sagittal 3D T2-FLAIR CUBE/SPACE/VISTA
    • Sagittal 3D T2-TSE

  2. Blood Specimens for Analysis of Biomarkers and Genetics [ Time Frame: 12-24 Hours, 2-Weeks, and 6-Months following Traumatic Brain Injury (TBI) ]
    To support future brain research

  3. Baseline Outcome Assessment (Composite Measure) [ Time Frame: At baseline following Traumatic Brain Injury (TBI) ]
    • Rivermead Post-Concussive Symptom Questionnaire (RPQ)
    • Brief Symptom Inventory (BSI-18)
    • Standardized Assessment of Concussion (SAC)

  4. Follow-Up Outcome Assessment (Composite Measure) [ Time Frame: 2-Weeks, 6-Weeks, 3-Months, and 6-Months following Traumatic Brain Injury (TBI) ]
    • Glasgow Outcome Scale Extended Revised (R-GOSE)
    • Functional Status Exam (FSE)
    • Posttraumatic Stress Disorder Checklist (PCL-5)
    • Brief Symptom Inventory (BSI-18)
    • Rivermead Post-Concussive Symptom Questionnaire (RPQ)
    • Trail Making Test (TMT)
    • Wechsler Adult Intelligence Scale IV - Processing Speed Index (WAIS IV-PSI)
    • Rey Auditory Verbal Learning Test (RAVLT)
    • Qualify of Life After Brain Injury -Overall Scale (QOLIBRI-OS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will enroll patients presenting to the Healthcare Facility with a history of acute TBI within the last 12 hours (acute injury) in which the patient has sustained a traumatically induced* physiological disruption of brain function, as manifested by ≥ one of the following:

  • Any period of loss of consciousness
  • Any loss of memory for events immediately before or after the accident
  • Any alteration of mental state at the time of the accident (feeling dazed, disoriented, and/or confused)
  • Focal neurologic deficits that may or may not be permanent

    • Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head
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 traumatic brain injury resulting from an insult to the head by an external force within 12 hours of the injury.
  4. Subject has a computed tomography (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, CS-2018-0009
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171960


Locations
Show Show 21 study locations
Sponsors and Collaborators
Abbott Point of Care
United States Department of Defense
University of California, San Francisco
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Responsible Party: Abbott Point of Care
ClinicalTrials.gov Identifier: NCT04171960    
Other Study ID Numbers: CS-2018-0009
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abbott Point of Care:
i-STAT
Traumatic Brain Injury
Biomarkers
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries