Head injury serum markers for assessing response to trauma: Design of the HeadSMART study.
Matthew E Peters, Vani Rao, Kathleen T Bechtold and 17 others
PMID 28140672WHAT IT FOUND
Emergency patients with suspected head injury are being followed with serial blood samples to test biomarkers for diagnosis and prognosis.
The first 300 were mostly mild injury with normal CT. No biomarker results are available yet.
Key findings
01The study is an ongoing 6-month prospective cohort of emergency department patients evaluated for TBI, with comparison groups of trauma without head trauma and healthy persons.
02Of the first 300 participants with suspected TBI, 210 met criteria for TBI, and 170 of those were classified as mild TBI.
03Among the first 300 suspected TBI participants, 294 had Glasgow Coma Scale scores of 13 to 15 and 244 had normal head CT scans.
STILL TO COME
How it was doneWhat they found
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What it does not show
This is a design and enrollment report, not a report of biomarker results, so it cannot tell clinicians whether blood tests diagnose TBI or predict recovery. The study is ongoing, and the comparison groups were not analysed in detail in this paper. Enrolled participants differed from eligible participants who were not enrolled, so the enrolled sample may not represent all eligible emergency department patients. Most enrolled participants had mild injury and normal head CT scans, so the description may not extend to more severe brain injury. The study uses clinical criteria for TBI diagnosis, and the paper notes that there is no gold standard for TBI diagnosis.
Declared interests
The study is sponsored by ImmunArray, and the sponsor measures the biomarkers.
The easy way to misread this
Do not conclude that blood biomarkers can diagnose TBI or replace head CT. This paper reports the HeadSMART design and enrolled participant characteristics; it does not report biomarker results.