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Search / Trial NCT06834659

Correlation and Rapid Analysis of Neurological Injury Using Markers

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Feb 13, 2025

Trial Information

Current as of July 04, 2025

Not yet recruiting

Keywords

Biomarkers Traumatic Brain Injury

ClinConnect Summary

This clinical trial is looking at a new blood test called the Abbott i-STAT™ TBI Plasma Test, which helps detect certain markers in the blood that may indicate brain injury in adults who have experienced a traumatic brain injury (TBI). Every year, millions of people suffer from TBIs, and getting accurate and timely diagnoses is crucial for their recovery. The goal of this study is to see how well this blood test can identify injuries, especially in patients with mild TBIs, by comparing its results with standard imaging tests like CT scans.

To participate in this study, individuals must be between 18 and 65 years old and have come to the emergency department due to a TBI. Participants will simply provide a blood sample during their regular care, which will be analyzed within 12 hours of their injury. The research team will use this data to better understand the relationship between the presence of these brain markers and the severity of the injury. Importantly, no extra procedures are needed beyond what is usually done in the emergency department. This study aims to improve how we diagnose brain injuries and ultimately help patients recover more effectively.

Gender

ALL

Eligibility criteria

  • 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.

About Università Vita Salute San Raffaele

Università Vita-Salute San Raffaele is a prestigious Italian academic institution renowned for its commitment to advancing healthcare through innovative research and education. Located in Milan, it integrates cutting-edge scientific inquiry with clinical practice, fostering interdisciplinary collaboration among healthcare professionals. The university is dedicated to improving patient outcomes and public health by conducting rigorous clinical trials that adhere to the highest ethical standards. Its focus spans various medical fields, leveraging state-of-the-art facilities and a strong network of partnerships to drive advancements in medical science and contribute to the global healthcare community.

Locations

Milan, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported