Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers (MBI01)
Brain Injuries, Traumatic, Biomarkers, Microwave Imaging
About this trial
This is an interventional diagnostic trial for Brain Injuries, Traumatic focused on measuring Microwave Imaging
Eligibility Criteria
Inclusion Criteria (groups A and B):
- Verbal Informed Consent in the acute phase.
- Signed Informed Consent Form after the acute phase. On behalf of the patient, independent witness signed informed consent (in cases where the patient is unable to sign).
- Acute trauma patient with suspected head injury
- Time from injury to measurement procedure not longer than 8 hours 15 min
- Head CT prescribed by treating physician
- Patient is ≥ 18 years of age
- Patient is deemed clinically stable
Exclusion Criteria (groups A and B):
- Patient has suspected cervical spine fracture, per the Investigator's judgement
- Patient has by CT confirmed cervical spine fracture
- Patient has confirmed skull fracture with risk for dislocation.
- Patient has a shunt or other foreign object implanted intracranially (if known by medical records)
- Patient has agraffes or other metal parts, thick bandage (>1cm), or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
- Patient diagnosed with a condition associated with risk of poor protocol compliance
- The measurement procedure is deemed to interfere with the standard of care
- Other condition or symptoms preventing the patient from entering the trial, per the investigator´s judgment
Inclusion Criteria (Group C):
- Patient is ≥ 18 years of age
- Signed informed consent
Exclusion Criteria (Group C):
• Previous stroke or other diagnosed and/or treated brain injury
Sites / Locations
- Helsingborg General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Traumatic intracranial hemorrhage
Trauma without traumatic intracranial hemorrhage
Healthy age-matched volunteers
Patients with traumatic intracranial hemorrhage diagnosed by Computerized Tomography of the head
Patients with trauma to the head but traumatic intracranial hemorrhage ruled out by Computerized tomography of the head
Healthy age-matched volunteers with no previous trauma to the head within the past two weeks.