Correlation and Rapid Analysis of Neurological Injury Using Markers

NCT06834659 | Not Yet Recruiting

• 1 other identifier: CRANIUM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Biomarkers; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Evaluation of the real-world effectiveness of the innovative technology

  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).

  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.

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.

  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.

Study Arms (1)

Adult patients with TBI

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of adult patients aged between 18 and 65 years, conscious and unconscious, who present to the emergency department with traumatic brain injury (TBI) at triage. TBI is defined as trauma resulting from an external physical force capable of causing temporary or permanent alterations in consciousness and/or neurological function. The clinical severity of TBI (mild, moderate, or severe) will be assessed using the Glasgow Coma Scale (GCS), ensuring alignment with the study objectives.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, Italy, 20132, Italy

Location

Related Publications (1)

• Oris C, Bouillon-Minois JB, Kahouadji S, Pereira B, Dhaiby G, Defrance VB, Durif J, Schmidt J, Moustafa F, Bouvier D, Sapin V. S100B vs. "GFAP and UCH-L1" assays in the management of mTBI patients. Clin Chem Lab Med. 2023 Dec 1;62(5):891-899. doi: 10.1515/cclm-2023-1238. Print 2024 Apr 25.

  PMID: 38033294 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Jody F. Capitanio, MD

CONTACT

+39 02 26433047; capitanio.jodyfilippo@hsr.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 19, 2025
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)