Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers

NCT04666766 | Unknown DMC

• 1 other identifier: MBI01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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 serum.

Conditions

Brain Injuries, Traumatic; Biomarkers; Microwave Imaging

Keywords

Microwave Imaging

Outcome Measures

Primary Outcomes (1)

• Ability to detect intracranial hemorrhage

  The ability of the device MD100, with and without brain biomarkers (Aβ40, Aβ42, GFAP, H-FABP, S100B, NF-L, NSE, UCH-L1 and IL-10) to detect traumatic intracranial haemorrhage, as measured by the area under the receiver operating characteristics curve.

  3.5 years

Secondary Outcomes (3)

• Estimating anatomic position of intracranial hemorrhage

  3.5 years

• Estimating volume of intracranial hemorrhage

  3.5 years

• Adverse events of microwave scan

  3.5 years

Study Arms (3)

Traumatic intracranial hemorrhage

ACTIVE COMPARATOR

Patients with traumatic intracranial hemorrhage diagnosed by Computerized Tomography of the head

Device: Microwave scanning of the head

Trauma without traumatic intracranial hemorrhage

ACTIVE COMPARATOR

Patients with trauma to the head but traumatic intracranial hemorrhage ruled out by Computerized tomography of the head

Device: Microwave scanning of the head

Healthy age-matched volunteers

ACTIVE COMPARATOR

Healthy age-matched volunteers with no previous trauma to the head within the past two weeks.

Device: Microwave scanning of the head

Interventions

Microwave scanning of the head DEVICE

A scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage.

Also known as: Assay of 9 different brain biomarkers

Healthy age-matched volunteers; Trauma without traumatic intracranial hemorrhage; Traumatic intracranial hemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient is ≥ 18 years of age
• Signed informed consent
• Previous stroke or other diagnosed and/or treated brain injury

Sponsors & Collaborators

• Region Skane: lead
• Medfield Diagnostics: collaborator

Study Sites (1)

Helsingborg General Hospital

Helsingborg, Skåne County, 25252, Sweden

RECRUITING

Related Publications (1)

• Vedin T, Bergenfeldt H, Holmstrom E, Lundager-Forberg J, Edelhamre M. Microwave scan and brain biomarkers to rule out intracranial hemorrhage: study protocol of a planned prospective study (MBI01). Eur J Trauma Emerg Surg. 2022 Apr;48(2):1335-1342. doi: 10.1007/s00068-021-01671-7. Epub 2021 May 4.

  PMID: 33944977 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tomas J Vedin, MD, PhD

  Region Skåne and Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas J Vedin, MD, PhD

CONTACT

+464263131; tomas.vedin@med.lu.se

Jacob Lundager Foberg, MD, PhD

CONTACT

+464261000; jakob.lundager-forberg@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: No results of the biomarker assays or microwave scans will be visible to the care givers or the participants.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 14, 2020
• Study Start: September 1, 2021
• Primary Completion: January 10, 2025
• Study Completion: January 12, 2026
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)