Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-28 @ 2:33 PM
Study NCT ID:
NCT05189561
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2021-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-04', 'releaseDate': '2025-05-20'}], 'estimatedResultsFirstSubmitDate': '2025-05-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D046748', 'term': 'Hematoma, Epidural, Spinal'}, {'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D000070624', 'term': 'Brain Contusion'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003288', 'term': 'Contusions'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-19', 'size': 200422, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-11T21:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2021-11-26', 'studyFirstSubmitQcDate': '2022-01-08', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of intracranial hematoma', 'timeFrame': 'Immediately after the test', 'description': 'To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.'}], 'secondaryOutcomes': [{'measure': 'Detection rate of clinically significant intracranial hematoma', 'timeFrame': 'Immediately after the test', 'description': 'To evaluate detection rate of clinically significant intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India), which requires admission or surgical intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['traumatic brain injury', 'traumatic intracranial hematoma', 'extradural hematoma', 'subdural hematoma', 'cerebral contusion', 'near-infrared spectroscopy'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nSo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute traumatic brain injury patients reaching the hospital\n\nExclusion Criteria:\n\n* Major scalp laceration or active bleeding.\n* Significant extracranial hematoma.'}, 'identificationModule': {'nctId': 'NCT05189561', 'briefTitle': 'Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Mental Health and Neuro Sciences, India'}, 'officialTitle': 'Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury', 'orgStudyIdInfo': {'id': 'NIMHANS/24thIEC(BS&NSDIV)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cerebo®', 'description': 'Participants undergoing scanning using NIRS device.', 'interventionNames': ['Other: near-infrared scanner']}], 'interventions': [{'name': 'near-infrared scanner', 'type': 'OTHER', 'otherNames': ['Cerebo'], 'description': 'Tests to be administered: Near Infra-Red Scanning of the head at the bedside.\n\nTime taken for testing: Two minutes\n\nBiological samples collected: None\n\nFrequency of testing/collection: Once\n\nRisks for the participants while being tested: None', 'armGroupLabels': ['Cerebo®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560029', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'NIMHANS', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Dhaval Shukla, MCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Mental Health and Neuro Sciences, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health and Neuro Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. of Neurosurgery', 'investigatorFullName': 'Dhaval Shukla', 'investigatorAffiliation': 'National Institute of Mental Health and Neuro Sciences, India'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-05-20', 'type': 'RELEASE'}, {'date': '2025-06-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dhaval Shukla, Prof. of Neurosurgery, National Institute of Mental Health and Neuro Sciences, India'}}}}