Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-01 @ 4:27 PM
Study NCT ID:
NCT04900168
Status:
UNKNOWN
Last Update Posted:
2023-07-27
First Post:
2021-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 832}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-05-23', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Good neurologic outcome', 'timeFrame': 'Within 6 months after traumatic brain injury', 'description': 'The proportion of patients with good neurological outcomes (GOSE: 5-8) in each group at 6 months after traumatic brain injury'}], 'secondaryOutcomes': [{'measure': '6 months mortality', 'timeFrame': 'Within 6 months after traumatic brain injury', 'description': 'The mortality of patients in each group at 6 months after traumatic brain injury'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Within 1 month after traumatic brain injury', 'description': 'The mortality of patients in each group during hospitalization'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intracranial Pressure'], 'conditions': ['Moderate Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '26927279', 'type': 'BACKGROUND', 'citation': 'Godoy DA, Rubiano A, Rabinstein AA, Bullock R, Sahuquillo J. Moderate Traumatic Brain Injury: The Grey Zone of Neurotrauma. Neurocrit Care. 2016 Oct;25(2):306-19. doi: 10.1007/s12028-016-0253-y.'}, {'pmid': '25702207', 'type': 'BACKGROUND', 'citation': 'Hawryluk GW, Manley GT. Classification of traumatic brain injury: past, present, and future. Handb Clin Neurol. 2015;127:15-21. doi: 10.1016/B978-0-444-52892-6.00002-7.'}, {'pmid': '28504109', 'type': 'BACKGROUND', 'citation': 'Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.'}, {'pmid': '27654000', 'type': 'BACKGROUND', 'citation': "Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432."}, {'pmid': '29369057', 'type': 'BACKGROUND', 'citation': 'Watanitanon A, Lyons VH, Lele AV, Krishnamoorthy V, Chaikittisilpa N, Chandee T, Vavilala MS. Clinical Epidemiology of Adults With Moderate Traumatic Brain Injury. Crit Care Med. 2018 May;46(5):781-787. doi: 10.1097/CCM.0000000000002991.'}, {'pmid': '2072163', 'type': 'BACKGROUND', 'citation': 'Lobato RD, Rivas JJ, Gomez PA, Castaneda M, Canizal JM, Sarabia R, Cabrera A, Munoz MJ. Head-injured patients who talk and deteriorate into coma. Analysis of 211 cases studied with computerized tomography. J Neurosurg. 1991 Aug;75(2):256-61. doi: 10.3171/jns.1991.75.2.0256.'}, {'pmid': '22182868', 'type': 'BACKGROUND', 'citation': 'Peterson EC, Chesnut RM. Talk and die revisited: bifrontal contusions and late deterioration. J Trauma. 2011 Dec;71(6):1588-92. doi: 10.1097/TA.0b013e31822b791d.'}, {'pmid': '19197220', 'type': 'BACKGROUND', 'citation': "Compagnone C, d'Avella D, Servadei F, Angileri FF, Brambilla G, Conti C, Cristofori L, Delfini R, Denaro L, Ducati A, Gaini SM, Stefini R, Tomei G, Tagliaferri F, Trincia G, Tomasello F. Patients with moderate head injury: a prospective multicenter study of 315 patients. Neurosurgery. 2009 Apr;64(4):690-6; discussion 696-7. doi: 10.1227/01.NEU.0000340796.18738.F7."}, {'pmid': '16498188', 'type': 'BACKGROUND', 'citation': 'Balestreri M, Czosnyka M, Hutchinson P, Steiner LA, Hiler M, Smielewski P, Pickard JD. Impact of intracranial pressure and cerebral perfusion pressure on severe disability and mortality after head injury. Neurocrit Care. 2006;4(1):8-13. doi: 10.1385/NCC:4:1:008.'}, {'pmid': '10616075', 'type': 'BACKGROUND', 'citation': 'Juul N, Morris GF, Marshall SB, Marshall LF. Intracranial hypertension and cerebral perfusion pressure: influence on neurological deterioration and outcome in severe head injury. The Executive Committee of the International Selfotel Trial. J Neurosurg. 2000 Jan;92(1):1-6. doi: 10.3171/jns.2000.92.1.0001.'}, {'pmid': '29401746', 'type': 'BACKGROUND', 'citation': 'Harary M, Dolmans RGF, Gormley WB. Intracranial Pressure Monitoring-Review and Avenues for Development. Sensors (Basel). 2018 Feb 5;18(2):465. doi: 10.3390/s18020465.'}, {'pmid': '16698860', 'type': 'BACKGROUND', 'citation': 'Steiner LA, Andrews PJ. Monitoring the injured brain: ICP and CBF. Br J Anaesth. 2006 Jul;97(1):26-38. doi: 10.1093/bja/ael110. Epub 2006 May 12.'}, {'pmid': '28987174', 'type': 'BACKGROUND', 'citation': 'Leinonen V, Vanninen R, Rauramaa T. Raised intracranial pressure and brain edema. Handb Clin Neurol. 2017;145:25-37. doi: 10.1016/B978-0-12-802395-2.00004-3.'}, {'pmid': '30497133', 'type': 'BACKGROUND', 'citation': 'Muballe KD, Sewani-Rusike CR, Longo-Mbenza B, Iputo J. Predictors of recovery in moderate to severe traumatic brain injury. J Neurosurg. 2018 Nov 9;131(5):1648-1657. doi: 10.3171/2018.4.JNS172185. Print 2019 Nov 1.'}, {'pmid': '31846845', 'type': 'BACKGROUND', 'citation': 'Li Z, Xu F, Li Y, Wang R, Zhang Z, Qu Y. Assessment of intracranial pressure monitoring in patients with moderate traumatic brain injury: A retrospective cohort study. Clin Neurol Neurosurg. 2020 Feb;189:105538. doi: 10.1016/j.clineuro.2019.105538. Epub 2019 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China.\n\nDesign and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. It is a 2-group design. Neurologic outcome is evaluated by extended Glasgow outcome score(GOSE) at 6 months.\n\nInterventions and Duration This is an observational study. The decision of intracranial pressure monitoring is made by the relatives of patient. Management of all patients will be consistent with protocols presently being used in the study hospitals. For patients who received ICP monitoring, the management will also be based specifically on the presence of intracranial hypertension. Each patient will be evaluated at 6 months post injury on neurological outcomes.\n\nSample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient with acute moderate traumatic brain injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of head trauma\n* 18 ≤ age ≤ 70 years\n* Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)\n* Glasgow coma scale at admission: 9-12\n* Arriving at hospital within 24 hours after injury\n* Systolic blood pressure ≥100 millimeter of mercury\n* No pregnant\n\nExclusion Criteria:\n\n* Refusing follow up visit\n* Penetrating head injury, spine or spinal cord injury\n* Surgical treatment in other hospital before admission\n* Cardiopulmonary resuscitation after injury or in need of blood transfusion due to active bleeding\n* Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)\n* Prior history of head trauma or stroke\n* Multiple injuries, with severity score of other parts\\>18\n* Rhabdomyolysis, with blood creatine kinase (CK)\\>5000 international unit/L\n* Injury of aorta, carotid artery or vertebral artery\n* Serum creatinine (female)\\>1.2mg/dL (106μmol/L), serum creatinine (male)\\>1.5mg/dL (133μmol/L)\n* Glomerular filtration rate (eGFR) \\<60 milliliter/min\n* Body mass index (BMI) \\<18.5kg/m2 or \\>40kg/m2\n* Estimated survival time less than 1 year\n* Participating in other on-going clinical researches\n* Other systemic diseases: uremia, liver cirrhosis, malignant tumor, mental illness, drug, or alcohol dependence, etc.'}, 'identificationModule': {'nctId': 'NCT04900168', 'acronym': 'IPMMTBI', 'briefTitle': 'Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'A Multi-center Observational Cohort Study of Management of Moderate Traumatic Brain Injury With or Without Intracranial Pressure Monitoring in Patients With Moderate Traumatic Brain Injury in China', 'orgStudyIdInfo': {'id': '202102-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICP monitoring group', 'description': 'patients received ICP monitoring', 'interventionNames': ['Device: Intracranial pressure monitoring']}, {'label': 'conventional treatment group', 'description': 'patients without ICP monitoring and received conventional treatment'}], 'interventions': [{'name': 'Intracranial pressure monitoring', 'type': 'DEVICE', 'description': 'An invasive method to monitor the intracranial pressure of patient', 'armGroupLabels': ['ICP monitoring group']}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'state': 'Shannxi Province', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhihong Li', 'role': 'CONTACT', 'email': '409615390@qq.com', 'phone': '+86-13709183909'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Zhihong Li, Doctor', 'role': 'CONTACT', 'email': '409615390@qq.com', 'phone': '+81-029-84717821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}