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Recruiting NCT07373509

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

— Observational TBI (Traumatic Brain Injury) Implementation Research

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: i-STAT Alinity TBI test.
Who it may be relevant to
Registry conditions: TBI (Traumatic Brain Injury), Implementation Research. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments

Overview

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

Detailed description

Objective:

The objective of this study is to utilize the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to identify determinants for implementing the 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.

Specific Aims:

Aim 1) Evaluate the effectiveness of the whole blood iSTAT Alinity test in determining the need for a head computed tomography (CT) scan in approximately 140 patients with a Glasgow Coma Score (GCS) 13-15 in the emergency department (ED) (approximately 47 per site) while assessing two novel outcomes with significant clinical implications (i.e., reduction in ED length of stay and predictive utility for ED revisits for the same injury).

Aim 2) Evaluate determinants for routine use of the whole blood iSTAT Alinity test by assessing acceptability, adoption, appropriateness and feasibility of the test at the organizational- and physician-level for each site and determine how these factors interplay with patient perspectives and knowledge to influence implementation of the test.

Aim 3) Develop a site-specific implementation blueprint for use of the whole blood iSTAT Alinity test in determining the need for a head CT scan and pilot test the blueprint in approximately 140 patients with GCS 13-15 in the ED (approximately 47 per site).

Interventions

  • Device i-STAT Alinity TBI test
    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.

Primary outcome measures

  • Rate of CT scans completed [Time frame: Up to 5 hours (from enrollment to CT scan completion)]
Secondary outcome measures (8)
  • ED patient length of stay [Time frame: Up to 5 hours (from arrival to discharge)]
  • Patient return visit to ED [Time frame: Up to two weeks]
  • Military Acute Concussion Evaluation-2 (MACE-2) [Time frame: Visit 1 (ED visit)]
  • Neurobehavioral Symptom Inventory (NSI) [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)]
  • Modified Rosenbaum Concussion Knowledge and Attitudes Survey (RoCKAS) [Time frame: Visit 1 (ED visit)]
  • Mobilizing Implementation of iPARIHS Facilitation Planning Tool (Mi-PARIHS) [Time frame: Visit 1 (enrollment) and again at 39 months (study conclusion)]
  • Decisional Conflict Scale (DCS) [Time frame: Visit 1 (enrollment) and again at 39 months (study conclusion)]
  • Implementation Questionnaire [Time frame: Visit 1 (enrollment) and again at 39 months (study conclusion)]

Eligibility criteria

Inclusion criteria

  • 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
  • Meets Department of Defense (DoD) definition of mTBI:

A traumatically induced physiological disruption of brain function as a result of an external force that is indicated by new onset or worsening of at least one of the following clinical signs immediately following the event:

  • 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)
  • Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury)

Exclusion criteria

  • 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
  • Contraindication or inability to complete blood draw
  • Significant polytrauma that, in the opinion of the principal investigators, could impact peripheral GFAP levels or require a full body scan
  • History of penetrating TBI
  • History of neurosurgical intervention for previous TBI
  • Penetrating TBI for current injury
  • Any history of brain surgery
  • Any history of brain tumor
  • Patients on psychiatric hold

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT07373509 · STUDY25010137 · HT94252510275

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗