Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers (MBI01)

Region Skane

Status: Enrolling

Conditions: Microwave Imaging; Biomarkers; Brain Injuries, Traumatic

Treatments: Device: Microwave scanning of the head

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04666766

MBI01

Details and patient eligibility

About

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.

Full 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 scanning characteristics and biomarkers in patients with traumatic intracranial haemorrhage (TICH) (Group A) will be compared to patients with head trauma that do not have TICH (Group B). All adult patients with trauma to the head will be eligible for inclusion if a medical professional has evaluated the risk of spine injury. After additional physical examination, control of inclusion- and exclusion criteria and after informed consent has been acquired, the microwave measurement and blood sampling will be performed. Before enrolment in the study, and in the acute phase, one of the investigators or a member of the investigator staff must explain verbally the implications of study participation to the patient, and the patient is asked to give a verbal consent. As soon as is practically possible after the acute phase of the disease, the patient will sign and personally date the informed consent form. In cases where the patient is not capable to read and/or sign the informed consent, due to disability, an independent witness shall be present throughout the process of reading the written informed consent and any other information aloud and explained to the prospective patient. As an independent witness, healthcare professionals who are not responsible or in any way involved in the patient's care or treatment are accepted. The independent witness can sign on the behalf of the patient in the presence of the patient and the Investigator. More details of the informed consent procedure are described in this Clinical Investigation Plan, section 6.3.

The microwave measurement will take less than five minutes (the duration of the actual measurement is about 1,5 min and will not interfere with the patient's standard of care). The Research Nurse or the Investigator documents all patient clinical trial information in the eCRF.

Safety and usability will be evaluated throughout the trial, and a safety follow-up will be performed by the Research Nurse or Investigator approximately 24 hours after the measurement procedure.

During the data processing phase of study, the result of the microwave measurement will be compared to the result of the biomarkers, CT examination and the patient's final diagnosis. As a control group, approximately 50 demographically matched healthy volunteers (Group C) will be asked to participate in the trial. The trial will provide knowledge of the predictive value of microwave measurement and biomarkers for the diagnosis of intracranial haemorrhages in the acute TBI phase.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups

Traumatic intracranial hemorrhage

Active Comparator group

Description:

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

Treatment:

Device: Microwave scanning of the head

Trauma without traumatic intracranial hemorrhage

Active Comparator group

Description:

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

Treatment:

Device: Microwave scanning of the head

Healthy age-matched volunteers

Active Comparator group

Description:

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

Treatment:

Device: Microwave scanning of the head