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Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
near-infrared scanner
Sponsored by
National Institute of Mental Health and Neuro Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Traumatic Brain Injury focused on measuring traumatic brain injury, traumatic intracranial hematoma, extradural hematoma, subdural hematoma, cerebral contusion, near-infrared spectroscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute traumatic brain injury patients reaching the hospital

Exclusion Criteria:

  • Major scalp laceration or active bleeding.
  • Significant extracranial hematoma.

Sites / Locations

  • NIMHANS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cerebo®

Arm Description

Participants undergoing scanning using NIRS device.

Outcomes

Primary Outcome Measures

Detection rate of intracranial hematoma
To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.

Secondary Outcome Measures

Detection rate of clinically significant intracranial hematoma
To evaluate detection rate of clinically significant intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India), which requires admission or surgical intervention.

Full Information

First Posted
November 26, 2021
Last Updated
February 14, 2022
Sponsor
National Institute of Mental Health and Neuro Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05189561
Brief Title
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection
Official Title
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Mental Health and Neuro Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and secondary hospitals. Detecting the underlying pathology is a major challenge especially for surgical cases. The outcome differs if the early intervention is performed. Near-infrared spectroscopy (NIRS) based device will detect the hematoma at the bedside. It is not the replacement of a CT scan but can help in triage. This is a large-scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan finding.
Detailed Description
The light used in the near-infrared spectrum, especially between 700 and 1000 nm, is able to penetrate the human tissue 'optical window'. Once the light has penetrated into the tissue, it is either scattered or absorbed. Light is mostly scattered by bones, skin and cerebral white matter. However, red blood cells, which represent roughly have a low scattering effect and high absorption. Utilising this principle, the emitter and detector could be used to measure the light scattered by the tissues. The 'optical density' of the tissue is calculated and by comparing the left and right hemispheres in the eight contralateral locations of the brain lobes where lesions with extravascular accumulation of haemoglobin can be detected. A NIRS device named Cerebo® was developed by Bioscan Research, Ahmedabad, India. It is a low power non risky device that can screen the patient's head multiple times without causing any side effect. The built in safety features in Cerebo® make it fail safe system for intentional as well as accidental exposure to laser beam. The average power and total power dissipation is very low. The system poses no risk to the patients who will be included in the study. So far the overall results of detection rate of hematoma using NIRS device are contradictory. It is not the replacement of a CT scan but can help in triage. In the present research the investigators plan to do a large scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, traumatic intracranial hematoma, extradural hematoma, subdural hematoma, cerebral contusion, near-infrared spectroscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebo®
Arm Type
Experimental
Arm Description
Participants undergoing scanning using NIRS device.
Intervention Type
Other
Intervention Name(s)
near-infrared scanner
Other Intervention Name(s)
Cerebo
Intervention Description
Tests to be administered: Near Infra-Red Scanning of the head at the bedside. Time taken for testing: Two minutes Biological samples collected: None Frequency of testing/collection: Once Risks for the participants while being tested: None
Primary Outcome Measure Information:
Title
Detection rate of intracranial hematoma
Description
To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.
Time Frame
Immediately after the test
Secondary Outcome Measure Information:
Title
Detection rate of clinically significant intracranial hematoma
Description
To evaluate detection rate of clinically significant intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India), which requires admission or surgical intervention.
Time Frame
Immediately after the test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute traumatic brain injury patients reaching the hospital Exclusion Criteria: Major scalp laceration or active bleeding. Significant extracranial hematoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhaval Shukla, MCh
Organizational Affiliation
National Institute of Mental Health and Neuro Sciences, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIMHANS
City
Bangalore
State/Province
KA
ZIP/Postal Code
560029
Country
India

12. IPD Sharing Statement

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Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

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