VIDAS TBI blood test in the assessment of subjects with a Glasgow Coma Scale (GCS ) 13-15

Overview

About this study

The purpose of this study is to assess the performance of a blood test within 12 hours of mild head trauma to exclude the presence of an intracranial lesion identified on patients getting a CT as part of their usual care.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adult subject ≥ 18 years old
Subject with a Glasgow Coma Scale (GCS) score between 13–15 on admission
Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site’s care usual care
Blood sampling possible within 12 h of injury (1 tube of 4-5 mL of blood)
Subject expected to stay at least 2 hours in the ED or in a ward
Subject with signed Informed Consent Form

Exclusion Criteria:

Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson’s disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)
Neurosurgery, stroke or transient ischemic attack within the last 30 days
Subject with an active cancer
Subject with penetrating head injury
Special populations, including women with known pregnancy or breastfeeding, prisoners, or institutionalized individuals

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/28/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Neha Raukar, M.D., M.S.	Contact us for the latest status	Contact information: Derek Vanmeter (507) 255-4732 Vanmeter.Derek@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Neha Raukar, M.D., M.S.

Contact us for the latest status

Contact information:

Derek Vanmeter

(507) 255-4732

Vanmeter.Derek@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials