Clinical trial NCT02728908: Detecting Traumatic Intracranial Hemorrhage With Microwave Technology
Official title: Detecting Traumatic Intracranial Hemorrhage With Microwave Technology - An Open Study Evaluating the Diagnostic Accuracy of a Microwave-based Device to Detect Traumatic Intracranial Hemorrhage (TICH), by Comparing Measurements on Trauma Patients With Confirmed vs Excluded TICH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Intracranial Hemorrhage
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Medfield Diagnostics
name: Chalmers University of Technology
First posted: 2016-04-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An open study evaluating the diagnostic accuracy of a microwave-based device to detect traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with confirmed vs excluded TICH

Detailed description: This open study will enrol trauma patients admitted to the Trauma Unit, Department of Surgery at Sahlgrenska University Hospital/Sahlgrenska. It will compare patients where TICH has been confirmed by CT (group A) to patients where CT has ruled out TICH (group B). Patients will be asked to participate in the study as early as possible after admission and CT scan. After physical examination, checking inclusion/exclusion criteria, and after informed consent has been acquired, the baseline microwave-based measurement will be performed. The diagnostic procedure is estimated to take 15 min; whereof total subject measurement time will be less than five minutes. Follow-up microwave measurements will be performed in conjunction with any follow-up CTs performed as part of the standard of care, during the hospitalized treatment period. If no follow-up CTs are performed as part of the standard of care, only the baseline microwave measurement will be performed.

Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the last microwave-based investigation is finalized.

Eligibility criteria: Inclusion Criteria:

* Patient admitted to Sahlgrenska University Hospital for trauma care.
* Patient deemed clinically stable.
* Patient should have a Glasgow Coma Scale rating of \> 14
* TICH confirmed (group A) or ruled out (group B) by CT, performed within the latest 12 hours.
* Patient ≥ 18 years of age.
* Patient has signed the Informed Consent Form.

Exclusion Criteria:

* Patient has confirmed or suspected skull fracture.
* Patient has confirmed or suspected cervical spine fracture.
* The diagnostic procedure is deemed to interfere with the standard of care.
* Patient has a shunt or other foreign object implanted intracranially.
* Patient has agraffes/other metal parts, thick (\> 1 cm) bandage, or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
* Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgment.
* Females who are pregnant.

Primary outcomes:
measure: The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH
timeFrame: The diagnostic procedure has an estimated duration of 15 minutes
Secondary outcomes:
measure: The accuracy for estimating the position of the intracranial hemorrhage through a mathematical analysis of the microwave data
timeFrame: The diagnostic procedure has an estimated duration of 15 minutes
measure: The accuracy for estimating the volume of the intracranial hemorrhage through a mathematical analysis of the microwave data
timeFrame: The diagnostic procedure has an estimated duration of 15 minutes
measure: Mean time (± standard deviation) needed to complete the measurement procedure
timeFrame: The diagnostic procedure has an estimated duration of 15 minutes
measure: Any adverse events occurring within 12 hours from the measurement procedure(s)
timeFrame: The diagnostic procedure has an estimated duration of 15 minutes, a safety follow-up will be performed 12 hours after the diagnostic procedure
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
name: Hans Granhed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: