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
Qualifiers
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
Treatments tested in this trial
- Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov