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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

• Устройство 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.

Первичные конечные точки

• Rate of CT scans completed [Срок оценки: Up to 5 hours (from enrollment to CT scan completion)]

Вторичные конечные точки (8)

• ED patient length of stay [Срок оценки: Up to 5 hours (from arrival to discharge)]
• Patient return visit to ED [Срок оценки: Up to two weeks]
• Military Acute Concussion Evaluation-2 (MACE-2) [Срок оценки: Visit 1 (ED visit)]
• Neurobehavioral Symptom Inventory (NSI) [Срок оценки: 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) [Срок оценки: Visit 1 (ED visit)]
• Mobilizing Implementation of iPARIHS Facilitation Planning Tool (Mi-PARIHS) [Срок оценки: Visit 1 (enrollment) and again at 39 months (study conclusion)]
• Decisional Conflict Scale (DCS) [Срок оценки: Visit 1 (enrollment) and again at 39 months (study conclusion)]
• Implementation Questionnaire [Срок оценки: Visit 1 (enrollment) and again at 39 months (study conclusion)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT07373509 · STUDY25010137 · HT94252510275

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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