Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-01 @ 10:52 AM
Study NCT ID:
NCT03033966
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020767', 'term': 'Intracranial Thrombosis'}], 'ancestors': [{'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ipsilateral Regional Cerebral Oxygen Saturation', 'timeFrame': 'From Recruitment till 48 hours postoperative (end of study)', 'description': 'Measurement of regional cerebral oxygen saturation over ipsilateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.'}], 'secondaryOutcomes': [{'measure': 'Contralateral Regional Cerebral Oxygen Saturation', 'timeFrame': 'From Recruitment till 48 hours postoperative (end of study)', 'description': 'Measurement of regional cerebral oxygen saturation over contralateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'From Recruitment till 48 hours postoperative (end of study)', 'description': 'Measurement of systolic blood pressure before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.'}, {'measure': 'Glasgow coma scale score', 'timeFrame': 'From Recruitment till 48 hours postoperative (end of study)', 'description': 'Measurement of Glasgow coma scale score before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.'}, {'measure': 'Arterial blood gas measurement', 'timeFrame': 'From Recruitment till 48 hours postoperative (end of study)', 'description': 'Arterial blood gas measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.'}, {'measure': 'Haemoglobin', 'timeFrame': 'From Recruitment till 48 hours postoperative (end of study)', 'description': 'Haemoglobin measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cerebral Oximetry', 'Cerebral Venous Thrombosis', 'Decompressive Craniectomy'], 'conditions': ['Cerebral Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage literature. How the brain injury affects cerebral oxygenation in patients with CVT is not currently known. Some of the factors that can affect cerebral oxygenation in patients with CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the cerebral oxygenation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Cerebral venous thrombosis for Decompressive craniectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy.\n\nExclusion Criteria:\n\n* Patients on inotropic support\n* Systolic blood pressure \\< 90 mmHg\n* Haemoglobin oxygen saturation \\<95%\n* Refusal of consent\n* Age \\<16 and \\> 65 years\n* Known history of diabetes or hypertension\n* Pregnancy\n* Any contraindication for application of cerebral oximetry sensors'}, 'identificationModule': {'nctId': 'NCT03033966', 'briefTitle': 'Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Mental Health and Neuro Sciences, India'}, 'officialTitle': 'Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis', 'orgStudyIdInfo': {'id': 'Item No.6.04, Neurosciences'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NIRS based Cerebral Oximetry', 'type': 'DEVICE', 'otherNames': ['Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA'], 'description': 'Cerebral Oximetric measurement before and after decompressive craniectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '560029', 'city': 'Bengaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'NIMHANS', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'May be shared on individual requests'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dhritiman Chakrabarti', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dhritiman Chakrabarti', 'investigatorAffiliation': 'National Institute of Mental Health and Neuro Sciences, India'}}}}