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Blood Test for Concussions

N/A

Recruiting

Research Sponsored by BioMérieux

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)

Adult subject ≥ 18 years old

Must not have

Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)

Subject with an active cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find a quick and accurate way to assess mild traumatic brain injuries in patients arriving at the Emergency Department. They are testing a new automated blood test developed by BioMérieux called the

Who is the study for?

This trial is for individuals who have experienced a mild traumatic brain injury (mTBI), commonly known as a concussion, and are being evaluated in an Emergency Department. Specific eligibility criteria details were not provided.

What is being tested?

The study is testing the VIDAS® TBI Test, which measures two biomarkers in the blood—GFAP and UCH-L1—to help decide if patients with mTBI need a CT scan. The goal is to see how well this test works in a real-world emergency setting.

What are the potential side effects?

Since the intervention involves blood tests rather than medication or invasive procedures, significant side effects are not expected. Minor discomfort from blood drawing may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide a blood sample within 12 hours of my injury.

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I am 18 years old or older.

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I am in the ER for a suspected minor head injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like dementia, Parkinson's, or MS.

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I currently have active cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with Mild Traumatic Brain injuryExperimental Treatment1 Intervention

Subjects presenting to the ED within 12 hours of suspected mild head trauma and a Glasgow Score of 13-15 undergo to blood collection for VIDAS® TBI \[GFAP, UCH-L1\] testing.

0 / 5Eligibility criteria met