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Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test

ConditionsTBI (Traumatic Brain Injury)Implementation Research
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShawn Eagle

About this trial

The objective of this study is to identify determinants for implementing the i-STAT Alinity whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications. The main questions it aims to answer are:

1. Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans. 2. What are the obstacles for using the i-STAT Alinity for its FDA-indicated use

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 or older

Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury

Any alteration of mental status (e.g., feeling dazed, disoriented, or confused)

Any period of loss of or a decreased level of consciousness, observed or self-report (loss of consciousness 30 minutes or less, an alteration of consciousness up to 24 hours)

Disqualifiers

Treating emergency department provider does not think a head CT scan is needed

Inability to obtain results for iSTAT Alinity TBI test within 24 hours of injury

Treating emergency department attending physician is not willing to participate

Pre-existing neurologic condition

Trial population

Emergency department providers and patients with suspected TBI

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • i-STAT Alinity TBI test

    Device

    The i-STAT TBI cartridge is a point-of-care test that measures the level of biomarkers associated with brain injury in whole blood to help assess patients with suspected mTBI within 24 hours after injury.

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: ED Providers0 interventions
Group B: ED patients1 intervention

Trial outcomes

Primary outcomes

1

Rate of CT scans completed

Rate of CTs completed for ED patient participants with a non-elevated i-STAT Alinity whole blood TBI test result.

Time frame
Up to 5 hours (from enrollment to CT scan completion)

Secondary outcomes

1

ED patient length of stay

Time frame
Up to 5 hours (from arrival to discharge)
2

Patient return visit to ED

Return visit for same injury within 2 weeks of initial visit

Time frame
Up to two weeks
3

Military Acute Concussion Evaluation-2 (MACE-2)

MACE 2 is a 15-minute multimodal tool that assists providers in the assessment and diagnosis of concussion. It includes: 1. An unscored screening section collected by clinician interview 2. A cognitive exam with scores ranging 0-30; with higher scores representing better performance. A score of 25 or less is considered abnormal. 3. Normal/Abnormal ratings of neurological function, symptom report, and visual-ocular functioning A total score is not generated.

Time frame
Visit 1 (ED visit)
4

Neurobehavioral Symptom Inventory (NSI)

The NSI is a 22-item scale of TBI symptoms which takes 2 minutes to complete. Total scores range from 0-88, with higher scores indicating more severe symptom burden.

Time frame
The NSI will be completed once during the patient's visit 1 (ED visit), and once at visit 2 (2-week remote follow-up)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shawn Eagle

Lead sponsor

University of Pittsburgh

Sponsor institution

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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