Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT
Diagnostic testThe i-STAT TBI cartridge is a point-of-care, whole-blood, biomarker-based assay that measures the level of biomarkers associated with brain injury in the bloodstream 24 hours after injury. Blood samples (5-10cc of whole blood) will be collected upon admission during a routine blood drawing in the ED. These samples will be tested using the iSTAT system for mild TBI biomarkers. In a subset of admitted patients, serial blood draws and iSTAT testing will be performed at 4, 8, 16, and 24 hours, depending on the patient's length of stay.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Published Biomarker GroupExperimental treatment 1 intervention
Group B: Blinded Biomarker GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants having a CT head scan from biomarker positive
The impact of biomarker results will be measured by the decision to obtain CT head imaging for patients presenting with mild TBI.
Time frame
During hospital admission (average 15 days).Secondary outcomes
1
Length of hospital stay
Length of hospital stay until discharge
Time frame
Hospital admission (average 15) days.2
Number of participants with intracranial findings predicted by biomarker findings
In participants undergoing CT head imaging, the proportion of participants with intracranial findings between biomarker-positive and biomarker-negative groups will be compared.
Time frame
Hospital admission (average 15) days.3
Number of readmissions for TBI-related symptoms
Data will be taken from electronic medical records (EMR) and participant's interviews.
Time frame
up to 6 months after hospital discharge4
Glasgow Outcome Scale-Extended (GOS-E)
Functional outcome measured by the GOS-E. The Glasgow Outcome Scale-Extended (GOS-E) is one of the most widely used outcome instruments to assess global disability and recovery after traumatic brain injury. The patient's overall rating is based on the lowest outcome category indicated on the scale. The overall rating is the lowest outcome category indicated by the person's answers (after discounting limitations or problems before injury). Deaths are taken from records, and on the GOS-E rating schema, a vegetative state (VS) or a score of 2 is the lowest category, and Upper Good Recovery (Upper GR) or a score of 8 is the highest. If the person has no limitations or impaired symptoms, their GOS-E rating is Upper GR (8).
Time frame
6 months after hospital dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov