NCT06834659

Correlation and Rapid Analysis of Neurological Injury Using Markers

CRANIUM: Post-Market Performance Follow-up Study for the Evaluation of the Presence of Circulating Plasma Brain Biomarkers in Peripheral Blood and Acute Traumatic Brain Injury in Adult Emergency Department Patients.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Each year, approximately 69 million people worldwide suffer from traumatic brain injuries (TBI), representing a significant burden on public health, society, and the economy. Timely and accurate care can influence short-, medium-, and long-term outcomes, making the reduction of diagnostic delays crucial. TBI diagnostics require careful consideration, as initial evaluations may differ from final assessments, and patient conditions may evolve over time. In this monocentric, observational, post-market follow-up study we aim to evaluate the Abbott i-STAT™ TBI Plasma Test in detecting circulating brain biomarkers (GFAP and UCH-L1) in adult patients with TBI. The study involves recruiting 200 adult patients (aged 18-65 years) presenting to the emergency department with TBI over a two-year period. For each participant, a blood sample will be collected as part of routine clinical care and analyzed using the Abbott i-STAT™ TBI Plasma Test within 12 hours of the trauma. The results will be compared with those obtained from cranial CT scans, the gold standard for diagnosing intracranial injuries. Specifically, the study aims to assess the diagnostic accuracy of the test in excluding intracranial injuries, particularly in cases of mild TBI, and to explore potential correlations between biomarker presence and injury severity. No additional procedures beyond routine clinical care are required, and all collected data will be used exclusively for the study's predefined objectives.

Detailed description

Post-Market Performance Follow-up Study

Conditions

• Traumatic Brain Injury (TBI) Patients

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-02-19
• Last updated: 2025-06-24

Locations

1 site across 1 country: Italy