Status:
UNKNOWN
Use of Cerebral Biomarkers in Minor Traumatic Brain Injury in the Emergency Unit
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Brain Injuries, Traumatic
Trauma
Eligibility:
All Genders
18+ years
Brief Summary
The use of serum biomarkers in the setting of the emergency department (ED) has been well characterized over the years as an adjunctive tool for the clinician in the setting of complex decision making...
Detailed Description
Study design Ambispective observational study without drug nor device. Population The study population will include all non-pregnant patients, who are \> 18 y.o. and meet the pre-specified inclusion ...
Eligibility Criteria
Inclusion
- Patients ≥18 years old;
- Patients who present to the ED within 4 hours since a traumatic event and reporting mTBI.
- Patients who own risk factors for delayed intracranial bleeding, defined as: history of anticoagulant therapy (VKA or DOACs) or known coagulopathy.
- Patients who undergo serial CT scan during the emergency evaluation as part of the standard ED care and if a sample of venous blood will be obtained at the moment of the visit.
- Signed written informed consent to study participation and personal data treatment.
Exclusion
- Age \<18 years old;
- Pregnant women;
- Refusal to sign written informed consent to study participation and personal data treatment.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
1510 Patients enrolled
Trial Details
Trial ID
NCT06069674
Start Date
October 1 2022
End Date
March 30 2024
Last Update
October 6 2023
Active Locations (1)
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1
Fondazione Policlinico Universitario "A. Gemelli" IRCCS
Roma, Italy, 00168