MedTrace Logo

Correlation and Rapid Analysis of Neurological Injury Using Markers

NCT06834659 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Traumatic Brain Injury (TBI) Patients

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-06-30
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06834659 on ClinicalTrials.gov