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NCT Number: NCT06834659

Correlation and Rapid Analysis of Neurological Injury Using Markers

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.

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Key information

Conditions

Traumatic Brain Injury (TBI) Patients Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Post-Market Performance Follow-up Study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation of the real-world effectiveness of the innovative technology

    Time frame: T1: first blood sample for biomarker testing and CT scan within 12 hours of trauma; T2: second blood sample for biomarker testing and CT scan at 12 to 24 hours post-initial evaluation, if clinically indicated due to neurological deterioration.

    Concordance Between Abbott i-STAT™ TBI Plasma Test Results and Cranial CT Scan in mTBI Cases.

    The primary outcome measure is the percentage agreement between the qualitative result of the Abbott i-STAT™ TBI Plasma Test (positive or negative) and the presence or absence of traumatic brain injury (TBI) or intracranial haemorrhages detected by cranial CT scan in patients with mild traumatic brain injury (mTBI).

Other outcomes

  1. Exploring the correlation between a positive result from the Abbott test and the progression of intracranial injuries (ICI) detected via CT scan, specifically in patients for whom a second CT scan is deemed necessary and performed.

    Time frame: T1: first blood sample for biomarker testing and CT scan within 12 hours of trauma; T2: second blood sample for biomarker testing and CT scan at 12 to 24 hours post-initial evaluation, in cases with neurological deterioration.

    The study will evaluate potential relationships between biomarkers identified by the test and the severity of the intracranial damage.

    This approach will allow for a comparative analysis of the presence of biomarkers in the peripheral blood and their association with evolving intracranial conditions. The study seeks to validate the clinical relevance of biomarkers in predicting not only the presence but also the extent and progression of intracranial damage.

Study contacts

Contact information is provided by the study sponsor or research team.

Jody F. Capitanio, MD

CONTACT

[email protected]

+39 02 26433047

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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.

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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