Status:
RECRUITING
Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Medfield Diagnostics
Conditions:
Brain Injuries, Traumatic
Biomarkers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate if traumatic intracranial hemorrhage can be safely ruled out by using a microwave scanner (MD100) in conjunction with a combination of different brain biomarkers analyzed in s...
Detailed Description
This is a prospective, open, multicentre trial that will enrol patients presenting to the Emergency Department (ED) because of isolated head trauma or head trauma as part of a multi trauma. Microwave ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 12 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04666766
Start Date
September 1 2021
End Date
January 12 2026
Last Update
January 25 2023
Active Locations (1)
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1
Helsingborg General Hospital
Helsingborg, Skåne County, Sweden, 25252