Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-04 @ 11:42 AM
Study NCT ID:
NCT03653728
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near Infra-red Spectroscopy for Detection of Intracranial Haematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'correlation of NIRS reading with Glasgow coma scale (GCS)', 'timeFrame': '1 week', 'description': 'correlation of NIRS reading with Glasgow coma scale (GCS). The scale GCS ranges from 3 to 15, in which a GCS of 3 indicates a status of deep coma, whereas a GCS of 15 indicates a fully conscious status.'}, {'measure': 'Number of CT performed', 'timeFrame': '1 week', 'description': 'Number of CT performed'}, {'measure': 'Other intervention such as blood product transfusion or operation', 'timeFrame': '1 week', 'description': 'Other intervention such as blood product transfusion or operation'}], 'primaryOutcomes': [{'measure': 'Correlation coefficient', 'timeFrame': '1 week', 'description': 'Correlation coefficient of near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect.'}], 'secondaryOutcomes': [{'measure': '30 days mortality', 'timeFrame': '30 days', 'description': '30 days mortality'}, {'measure': 'modified Rankin Scale', 'timeFrame': '3 months', 'description': 'modified Rankin Scale (mRS) at 3 months. The mRS scale ranges from 0 to 6, in which 0 indicates no disability, while 6 indicates death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-invasive monitoring; near-infrared spectroscopy; traumatic brain injury; cerebral contusion'], 'conditions': ['Traumatic Brain Injury', 'Intracerebral Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '26067457', 'type': 'BACKGROUND', 'citation': 'Folkerson LE, Sloan D, Cotton BA, Holcomb JB, Tomasek JS, Wade CE. Predicting progressive hemorrhagic injury from isolated traumatic brain injury and coagulation. Surgery. 2015 Sep;158(3):655-61. doi: 10.1016/j.surg.2015.02.029. Epub 2015 Jun 9.'}, {'pmid': '11794591', 'type': 'BACKGROUND', 'citation': 'Oertel M, Kelly DF, McArthur D, Boscardin WJ, Glenn TC, Lee JH, Gravori T, Obukhov D, McBride DQ, Martin NA. Progressive hemorrhage after head trauma: predictors and consequences of the evolving injury. J Neurosurg. 2002 Jan;96(1):109-16. doi: 10.3171/jns.2002.96.1.0109.'}, {'pmid': '18491950', 'type': 'BACKGROUND', 'citation': 'Narayan RK, Maas AI, Servadei F, Skolnick BE, Tillinger MN, Marshall LF; Traumatic Intracerebral Hemorrhage Study Group. Progression of traumatic intracerebral hemorrhage: a prospective observational study. J Neurotrauma. 2008 Jun;25(6):629-39. doi: 10.1089/neu.2007.0385.'}, {'pmid': '19575576', 'type': 'BACKGROUND', 'citation': 'Alahmadi H, Vachhrajani S, Cusimano MD. The natural history of brain contusion: an analysis of radiological and clinical progression. J Neurosurg. 2010 May;112(5):1139-45. doi: 10.3171/2009.5.JNS081369.'}, {'pmid': '27604312', 'type': 'BACKGROUND', 'citation': 'Weigl W, Milej D, Janusek D, Wojtkiewicz S, Sawosz P, Kacprzak M, Gerega A, Maniewski R, Liebert A. Application of optical methods in the monitoring of traumatic brain injury: A review. J Cereb Blood Flow Metab. 2016 Nov;36(11):1825-1843. doi: 10.1177/0271678X16667953. Epub 2016 Sep 7.'}, {'pmid': '28811212', 'type': 'BACKGROUND', 'citation': 'Kim B, Jeong H, Kim J, Kim T, Kim K, Lee H, Ahn S, Jo YH, Lee JH, Hwang JE. Incidence and risk factors of delayed intracranial hemorrhage in the emergency department. Am J Emerg Med. 2018 Feb;36(2):271-276. doi: 10.1016/j.ajem.2017.08.009. Epub 2017 Aug 4.'}, {'pmid': '15792505', 'type': 'BACKGROUND', 'citation': 'Chieregato A, Fainardi E, Morselli-Labate AM, Antonelli V, Compagnone C, Targa L, Kraus J, Servadei F. Factors associated with neurological outcome and lesion progression in traumatic subarachnoid hemorrhage patients. Neurosurgery. 2005 Apr;56(4):671-80; discussion 671-80. doi: 10.1227/01.neu.0000156200.76331.7a.'}, {'pmid': '16575328', 'type': 'BACKGROUND', 'citation': 'Chang EF, Meeker M, Holland MC. Acute traumatic intraparenchymal hemorrhage: risk factors for progression in the early post-injury period. Neurosurgery. 2006 Apr;58(4):647-56; discussion 647-56. doi: 10.1227/01.NEU.0000197101.68538.E6.'}, {'pmid': '20920925', 'type': 'BACKGROUND', 'citation': 'Poon WS, Wong GK, Ng SC. The quantitative time-resolved near infrared spectroscopy (TR-NIRs) for bedside cerebrohemodynamic monitoring after aneurysmal subarachnoid hemorrhage: can we predict delayed neurological deficits? World Neurosurg. 2010 May;73(5):465-6. doi: 10.1016/j.wneu.2010.03.029. No abstract available.'}, {'pmid': '9807611', 'type': 'BACKGROUND', 'citation': 'Gomersall CD, Leung PL, Gin T, Joynt GM, Young RJ, Poon WS, Oh TE. A comparison of the Hamamatsu NIRO 500 and the INVOS 3100 near-infrared spectrophotometers. Anaesth Intensive Care. 1998 Oct;26(5):548-57. doi: 10.1177/0310057X9802600512.'}, {'pmid': '9233756', 'type': 'BACKGROUND', 'citation': 'Gomersall CD, Joynt GM, Gin T, Freebairn RC, Stewart IE. Failure of the INVOS 3100 cerebral oximeter to detect complete absence of cerebral blood flow. Crit Care Med. 1997 Jul;25(7):1252-4. doi: 10.1097/00003246-199707000-00031. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants.\n\nNon-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these noninvasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources. Timely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as nearinfrared spectroscopy (NIRS) is to be investigated.\n\nThe aim of this study is to determine the sensitivity and specificity of NIRS as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain. Study design is Prospective sensitivity and specificity study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited. Outcome measures including correlation of non-invasive monitoring with near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect. Secondary outcome including 30 days mortality and functional outcome at 3 months.', 'detailedDescription': "Introduction: Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants.\n\nNon-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these non-invasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources.\n\nTimely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as near-infrared spectroscopy (NIRS) is to be investigated.\n\nAims and Hypotheses to be tested:\n\nThe aim of this study is to determine the sensitivity and specificity of near-infrared spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain.\n\nPlan of Investigation:\n\nThis is a prospective sensitivity and specificity correlation study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited.\n\nConsecutive patients fulfilling the inclusion and exclusion criteria are treated with standard of care with near-infrared spectroscopy (NIRS). Criteria to proceed for repeat CT Brain scan 1) clinical deterioration of GCS \\>2 points, 2) NIRS monitoring has increase in difference in absorbance of light at 760nm \\>0.3, or 3) 8 hours after admission for baseline interval scan for all patients as part of the standard of care. Non-invasive monitoring with near-infrared spectroscopy (NIRS) would be applied to all patients' forehead for consecutively 48 hours after admission.\n\nInclusion criteria\n\n1. Age greater than or equal to 18 years old,\n2. History of traumatic brain injury,\n3. Radiological evidence of intracranial haematoma,\n4. Glasgow Coma Scale (GCS) less than 15 upon admission,\n5. Not undergoing immediate operation,\n6. Admission to the general ward or high dependence unit of Neurosurgery, Prince of Wales Hospital.\n\nExclusion criteria\n\n1. Presence of frontal scalp laceration preventing the application of non-invasive monitoring on the forehead,\n2. Presence of pneumocephale,\n3. Requirement of immediate surgical intervention as judged by the on-call neurosurgeon.\n4. Patients who have joined other drug trial in the last four weeks;\n5. Pregnant or on breast feeding;\n6. Any other reasons that the researchers consider unsuitable.\n\nPrimary outcome - Correlation coefficient of near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect.\n\nSecondary outcomes\n\n\\- Secondary outcome including number of CT scan performed, correlation of NIRS reading with Glasgow coma scale (GCS), rate of intervention with either medical treatment such as use of mannitol, Transamin or blood product transfusion, or surgical treatment such as operation, 30 days mortality and functional outcome at 3 months.\n\nPurpose and Potential:\n\nNear-infrared spectroscopy (NIRS) can offer continuous neuro-monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. This allows early detection of delayed haematoma for early intervention. At the same time, the use of NIRS can potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive traumatic brain injury patients fulfilling the inclusion and exclusion criteria are treated with standard of care with near-infrared spectroscopy (NIRS).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than or equal to 18 years old,\n2. History of traumatic brain injury,\n3. Radiological evidence of intracranial haematoma,\n4. Glasgow Coma Scale (GCS) less than 15 upon admission,\n5. Not undergoing immediate operation,\n6. Admission to the general ward or high dependence unit of Neurosurgery, Prince of Wales Hospital.\n\nExclusion Criteria:\n\n1. Presence of frontal scalp laceration preventing the application of non-invasive monitoring on the forehead,\n2. Presence of pneumocephale,\n3. Requirement of immediate surgical intervention as judged by the on-call neurosurgeon.\n4. Patients who have joined other drug trial in the last four weeks;\n5. Pregnant or on breast feeding;\n6. Any other reasons that the researchers consider unsuitable.'}, 'identificationModule': {'nctId': 'NCT03653728', 'briefTitle': 'Near Infra-red Spectroscopy for Detection of Intracranial Haematoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Non-invasive Neuro-monitoring for Head Injury: Use of Near Infra-red Spectroscopy for Early Detection of Delayed Intracranial Haematoma', 'orgStudyIdInfo': {'id': 'NTEC-2018-0106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Traumatic brain injury with cerebral contusions', 'interventionNames': ['Device: Near infrared spectroscopy']}], 'interventions': [{'name': 'Near infrared spectroscopy', 'type': 'DEVICE', 'description': 'All patients would be receiving the same treatment including application of non-invasive monitoring with near-infrared spectroscopy (NIRS) together with the standard of care with interval CT Brain scan for all patients.\n\nNon-invasive monitoring with near-infrared spectroscopy (NIRS) is very safe and is in current daily routine clinical use for intraoperative patients.', 'armGroupLabels': ['Traumatic brain injury with cerebral contusions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurosurgery Resident', 'investigatorFullName': 'Dr. David Yuen Chung CHAN', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}