Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

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

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 Overview

• Status: Completed
• Conditions: Traumatic Intracranial Hemorrhage
• Intervention / Treatment: Device: Medfield Strokefinder MD100

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden, 413 45
      • Sahlgrenska University Hospital, Department of Surgery, Trauma Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH	The diagnostic ability of the device is calculated using a leave-one-out/n-fold cross-validation method	The diagnostic procedure has an estimated duration of 15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
The accuracy for estimating the position of the intracranial hemorrhage through a mathematical analysis of the microwave data	The diagnostic procedure has an estimated duration of 15 minutes
The accuracy for estimating the volume of the intracranial hemorrhage through a mathematical analysis of the microwave data	The diagnostic procedure has an estimated duration of 15 minutes
Mean time (± standard deviation) needed to complete the measurement procedure	The diagnostic procedure has an estimated duration of 15 minutes
Any adverse events occurring within 12 hours from the measurement procedure(s)	The diagnostic procedure has an estimated duration of 15 minutes, a safety follow-up will be performed 12 hours after the diagnostic procedure

Collaborators and Investigators

• Sponsor: Hans Granhed
• Collaborators: Chalmers University of Technology; Medfield Diagnostics
• Investigators: Principal Investigator: Hans Granhed, MD, PhD, Sahlgrenska University Hospital, Department of Surgery, Trauma Unit

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Hemorrhage; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic
• Other Study ID Numbers: TICH 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No