Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-01 @ 3:35 PM
Study NCT ID:
NCT06364059
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2024-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020199', 'term': 'Hematoma, Subdural, Acute'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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': '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': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056424', 'term': 'Decompressive Craniectomy'}], 'ancestors': [{'id': 'D019299', 'term': 'Decompression, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003399', 'term': 'Craniotomy'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of consciousness at time of injury', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The level of consciousness (using the Glasgow Coma Scale, 3-15 points, higher score means a better outcome) at the time of injury is analyzed.'}, {'measure': 'Initial size of subdural hematoma', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Initial size of subdural hematoma measured in millimetres using CT scan.'}, {'measure': 'Initial midline shift', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Initial size of midline shift measured in millimetres using CT scan.'}, {'measure': 'Chronic use of anti-clotting medication', 'timeFrame': 'once at time of admission', 'description': 'The number of patients on chronic anticoagulation therapy will be the subject of analysis.'}, {'measure': 'Trauma severity analyzed using Injury Severity Score (ISS).', 'timeFrame': 'once at time of admission', 'description': 'Trauma severity analyzed using Injury Severity Score. The ISS scores ranges from 1 to 75 points (Higher scores correspond to more severe injury and a higher risk of death).'}, {'measure': 'Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II)', 'timeFrame': 'within 24 hours of admission', 'description': 'Severity of patient illness will be analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) which ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death.'}, {'measure': 'The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC).', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The Glasgow Outcome Score allowing the objective assessment of the patient´s recovery after trauma brain injury. Allows a prediction of the long-term course of rehabilitation to return to work and everyday life. It uses five categories: 1. Death, 2. Persistent vegetative state, 3. Severe disability, 4. Moderate disability, 5. Low disability.'}, {'measure': 'The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months.', 'timeFrame': '6 months follow up', 'description': 'The Glasgow Outcome Scale Extended (GOSE) is an expanded version of the Glasgow Outcome Scale for evaluation of global disability and recovery after traumatic brain injury. It uses eight categories: 1. Death, 2. Vegetative state, 3. Lower severe disability, 4. Upper severe disability, 5. Lower moderate disability, 6. Upper moderate disability - some disability but can potentially return to some form of employment, 7. Lower good recovery - minor physical or mental defect, 8. Upper good recovery - full recovery.\n\nA GOSE analysis will be performed on a patient who has undergone evacuation of a subdural hematoma 6 months after the trauma.'}, {'measure': 'The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months.', 'timeFrame': '12 months follow up', 'description': 'The Glasgow Outcome Scale Extended (GOSE) is an expanded version of the Glasgow Outcome Scale for evaluation of global disability and recovery after traumatic brain injury. It uses eight categories: 1. Death, 2. Vegetative state, 3. Lower severe disability, 4. Upper severe disability, 5. Lower moderate disability, 6. Upper moderate disability - some disability but can potentially return to some form of employment, 7. Lower good recovery - minor physical or mental defect, 8. Upper good recovery - full recovery.\n\nA GOSE analysis will be performed on a patient who has undergone evacuation of a subdural hematoma 12 months after the trauma.'}], 'secondaryOutcomes': [{'measure': 'Number of revisions.', 'timeFrame': '24 hours', 'description': 'The number of re-operations that are required within 24 hours of the initial procedure will be analyzed.'}, {'measure': 'Time from injury to surgery.', 'timeFrame': '24 hours', 'description': 'The time from the onset of the injury to the evacuation of the subdural hematoma will be analyzed.'}, {'measure': 'Time of operation.', 'timeFrame': 'up to 4 hours', 'description': 'The operative time of the evacuation of the subdural hematoma will be analyzed.'}, {'measure': 'The need for reversal of the effects of anticoagulants.', 'timeFrame': '24 hours', 'description': 'The number of cases of need for reversal of the effect of chronic anticoagulant medication will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute subdural hematoma', 'Intracranial hemorrhage', 'Prognosis', 'Functional outcome'], 'conditions': ['Acute Subdural Hematoma', 'Acquired Brain Injury']}, 'descriptionModule': {'briefSummary': 'Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes.', 'detailedDescription': 'Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes. It is our belief that this research will provide valuable insights on the risk of mortality and functional outcomes for ASDH patients. Several clinical and radiologic factors have been identified within the general population that correlate with mortality rates and functional outcomes. There are a number of factors that must be considered in the evaluation of a patient with traumatic brain injury, and a comprehensive assessment is necessary to determine the best course of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who underwent surgery due to acute subdural hematoma in a single institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery due to ASDH\n* 12 months of follow-up\n* functional outcome measured by the Glasgow Outcome Scale Extended (GOSE).\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06364059', 'briefTitle': 'A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma', 'orgStudyIdInfo': {'id': 'aSDH-TT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery Group', 'description': 'Adult patients who underwent surgery due to acute subdural hematoma', 'interventionNames': ['Procedure: Decompressive craniectomy with evacuation of subdural hematoma']}], 'interventions': [{'name': 'Decompressive craniectomy with evacuation of subdural hematoma', 'type': 'PROCEDURE', 'description': 'Adult patients who underwent decompressive craniectomy with evacuation of subdural hematoma.', 'armGroupLabels': ['Surgery Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16209', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Military University Hospital Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Tomáš Tyll, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charles University, Czech Republic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Military University Hospital, Prague', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Michal Soták', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}