Correlation and Rapid Analysis of Neurological Injury Using Markers

Università Vita-Salute San Raffaele

Status: Not yet enrolling

Conditions: Traumatic Brain Injury (TBI) Patients

Study type: Observational

Funder types: Other

Identifiers

NCT06834659

CRANIUM

Details and patient eligibility

About

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.

Full description

Post-Market Performance Follow-up Study

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 to 65, male and female, presenting to the emergency department due to TBI, defined as trauma caused by an external force leading to temporary or permanent alterations in consciousness and/or neurological function. TBI severity is evaluated using the Glasgow Coma Scale (GCS).
• Sign of informed consent by patient or legal tutor

Exclusion criteria

• Pediatric patients (<18 years).
• Patients >65 years, to avoid potential confounding factors such as elevated GFAP levels associated with Alzheimer's disease.

Trial design

200 participants in 1 patient group

Adult patients with TBI

Description:

Adult patients (ages ≥18 and ≤65), conscious and unconscious, presenting to the emergency department with TBI at triage. TBI is defined as trauma caused by an external physical force capable of causing temporary or permanent alterations in consciousness and/or neurological function. Post Market Performance follow-up study: Application of the Abbott i-STAT™ TBI Plasma Test to all cases within 12 hours of cranial trauma for detecting GFAP and UCH-L1 biomarkers.