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Completed

NCT Number: NCT05189561

Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute traumatic brain injury patients reaching the hospital

Exclusion criteria

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

Treatment and study plan

near-infrared scanner

Other

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

Other names: Cerebo

Primary outcomes

  1. Detection rate of intracranial hematoma

    Time frame: Immediately after the test

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

Secondary outcomes

  1. Detection rate of clinically significant intracranial hematoma

    Time frame: Immediately after the test

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

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Official study title

Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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