Using microwaves and blood tests to detect brain injuries

Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers: A Prospective Study Evaluating Ability of Microwave Scanning in Conjunction With Biomarkers to Diagnose Traumatic Intracranial Hemorrhage

This study is testing if a microwave scanner and blood tests can help doctors quickly find out if people with head injuries have serious bleeding in their brains.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Region Skane (other)
• Locations: 1 site (Helsingborg, Skåne)
• Trial ID: NCT04666766 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a microwave scanner combined with blood biomarkers to rule out traumatic intracranial hemorrhage in patients with head trauma. It is a prospective, open, multicenter trial enrolling patients from the Emergency Department who have isolated head trauma or are part of multi-trauma cases. Participants will undergo microwave scanning and blood sampling, with comparisons made between those with and without traumatic intracranial hemorrhage. Informed consent will be obtained from all participants, ensuring ethical standards are met.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have sustained acute head trauma and are clinically stable.

Not a fit: Patients with suspected cervical spine fractures or confirmed skull fractures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and faster method for diagnosing traumatic brain injuries.

How similar studies have performed: While the use of microwave imaging is a novel approach, similar studies using biomarkers for brain injury detection have shown promise.

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

Where this trial is running

Helsingborg, Skåne

• Helsingborg General Hospital — Helsingborg, Skåne, Sweden (RECRUITING)

Study contacts

• Principal investigator: Tomas J Vedin, MD, PhD — Region Skåne and Lund University
• Study coordinator: Tomas J Vedin, MD, PhD

Conditions: Brain Injuries, Traumatic, Biomarkers, Microwave Imaging