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Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

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ClinicalTrials.gov Identifier: NCT03353246
Recruitment Status : Completed
First Posted : November 27, 2017
Results First Posted : May 28, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Duke University Hospital (DUH) who have sustained or who are suspected to have sustained head trauma and have consequently received a brain computed tomography (CT) scan(s).

Condition or disease Intervention/treatment Phase
Head Trauma Craniocerebral Injuries Crushing Skull Injury Head Injuries Head Injuries, Multiple Head Injuries, Closed Head Trauma,Closed Head Trauma Injury Head Trauma, Penetrating Head Injury, Minor Head Injury Major Head Injury, Open Injuries, Craniocerebral Injuries, Head Multiple Head Injury Trauma, Head Device: InfraScanner 2000™ Not Applicable

Detailed Description:

When applicable (conscious patient and/or family or legally authorized representative is present) the study will be introduced to the patient and relevant parties prior to the research team approaching the patient. While head trauma frequently results in impaired cognition and/or consciousness, and due to the urgency of these circumstances patients are often not accompanied by kin, whenever appropriate, the purpose of the research and the procedure will be explained in detail with all questions answered to the patient's and/or representative's satisfaction. Because patients who sustain head trauma injuries typically remain within the hospital for multiple days for monitoring and care, each participant may undergo multiple CT scans over the course of his or her hospitalization, affording the opportunity to one to numerous measurements from each patient during his or her hospital stay.

Within 30 minutes following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). The procedure will entail placing 8 plastic light guides upon the patient's scalp. The study team member will use the device to sequentially emit light through each of the 8 light guides so that the light is incident upon scalp (Image B). The device is engineered such that the light emitter and receiver are spaced ~4cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting the patient, placing the light guides, gathering the data, and removing the light guides should take ~10 minutes each time. The number of CT scans the patient receives determines the number of potential data collections. The patient will be approached by the study team following each CT scan to be scanned with the InfraScanner 2000™ (20). The patient and/or representative may refuse a scan during any encounter, and as such, the scan will not be done. For each patient scanned with the InfraScanner 2000™ they will be de-identified with a subject number, with age, sex, gender, skin color, hair color, hair thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT scan and near-infrared measurement. These data will be stored in de-identified form on Research Electronic Data Capture (REDCap) and/or Microsoft Excel 2016 on a secured DHTS server (S:\NSU_IRB\Pro00087011).

The collection period for each research subject concludes 30-days following his or her initial measurement with the InfraScanner 2000™, patient discharge, or patient death.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural Hematomas in Patients Admitted to Duke University Hospital: A Pilot Study
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018

Arm Intervention/treatment
Experimental: InfraScanner 2000™
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
Device: InfraScanner 2000™
The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.




Primary Outcome Measures :
  1. Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.

  2. Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.

  3. Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.

  4. Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.

  5. False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.

  6. False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.

  7. False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.

  8. False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.


Secondary Outcome Measures :
  1. Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.

  2. Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM.

  3. Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.

  4. False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.

  5. Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.

  6. False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level [ Time Frame: Up to 30 days after first CT scan ]
    Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient who presents to Duke University Hospital with suspected head trauma and receives a brain CT scan will be considered for this study.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353246


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Michael Haglund, MD, PhD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] May 7, 2018
Statistical Analysis Plan  [PDF] September 5, 2018

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03353246    
Other Study ID Numbers: Pro00087011
First Posted: November 27, 2017    Key Record Dates
Results First Posted: May 28, 2019
Last Update Posted: August 20, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Craniocerebral Trauma
Hematoma, Epidural, Cranial
Head Injuries, Closed
Head Injuries, Penetrating
Hematoma
Hematoma, Epidural, Spinal
Wounds and Injuries
Multiple Trauma
Hemorrhage
Pathologic Processes
Trauma, Nervous System
Nervous System Diseases
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Wounds, Nonpenetrating
Wounds, Penetrating