Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study
Recruiting
Observational Study
Mild Traumatic Brain Injury (mTBI)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- Hospital Universitario 12 de Octubre · Other
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About This Trial
This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necess…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)
1. The presence of a plausible traumatic mechanism observed/or related by the patient´s recount of the injury event.
2. Presence of one or more clinical…
Contacts