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Search / Trial NCT06069674

Use of Cerebral Biomarkers in Minor Traumatic Brain Injury in the Emergency Unit

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Oct 4, 2023

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of specific blood markers, called GFAP and UCH-L1, to help doctors better assess patients with mild traumatic brain injuries (mTBI) in the emergency department. These markers can be measured quickly after an injury and may help distinguish between those who have a serious brain injury and those who do not. The goal is to reduce unnecessary CT scans, which expose patients to radiation and increase healthcare costs, while ensuring that serious injuries are not missed.

To be eligible for the trial, participants must be at least 18 years old and visit the emergency department within four hours of a head injury. They should also have risk factors for bleeding in the brain, like being on blood-thinning medication. Those who join the study will have their blood drawn and may undergo a CT scan as part of their emergency care. The hope is that using these blood markers will help doctors make quicker and safer decisions about whether further imaging is needed.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • Age \<18 years old;
  • Pregnant women;
  • Refusal to sign written informed consent to study participation and personal data treatment.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported