Clinical trial NCT06932588: Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
Official title: Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injuries
Head Injury
Keywords: Biomarkers
Brain imaging
Brain trauma
Head CT scan
Mild traumatic brain injury (mTBI)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2025-04-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging.

In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).

Detailed description: The Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma (BRAIN-CT) study aims to determine whether immediate access to blood biomarker data can help doctors decide when a CT scan is necessary for patients with mild traumatic brain injury (mTBI). The study will also explore how biomarker data influences clinical outcomes, such as hospital stay duration, costs, and recovery. Additionally, it will identify specific patient groups where biomarker results may alter imaging decisions, assess the ability of biomarkers to predict worsening symptoms and develop predictive models to improve the accuracy of these tests compared to CT scans.

The study will enroll adults presenting with suspected mild traumatic brain injury (mTBI) in the emergency department at Grady Memorial Hospital. Minors, pregnant individuals, wards of the state, prisoners, and those with cognitive impairments will not be enrolled.

Participants will undergo blood-based biomarker testing upon ED presentation. Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-65 years old
* Mild TBI, defined as Glasgow Coma Scale (GCS) score 13-15, presenting within 24 hours of injury
* No prior head imaging for the same incident
* Presenting within 24 hours of onset of injury

Exclusion Criteria:

* Patients with penetrating head injury
* History of known brain abnormality including tumor, cerebrovascular malformation, recent brain surgery (within 6 months), prior head injury (within 6 months)
* Need for emergent surgical intervention for brain or alternate body organ injury
* Need for emergent bedside procedures for hemodynamic or orthopedic stabilization
* Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing.

Primary outcomes:
measure: Proportion of participants having a CT head scan from biomarker positive
timeFrame: During hospital admission (average 15 days).
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Hospital admission (average 15) days.
measure: Presence of intracranial findings predicted by biomarker findings
timeFrame: Hospital admission (average 15) days.
measure: Re-admission for TBI-related symptoms
timeFrame: up to 6 months after hospital discharge
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: 6 months after hospital discharge
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Jonathan Grossberg, MD
role: PRINCIPAL_INVESTIGATOR
References: