Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-03-14 @ 4:04 AM
Study NCT ID:
NCT02938468
Status:
UNKNOWN
Last Update Posted:
2020-07-01
First Post:
2016-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mgt of Chronic Subdural Hematoma Using Dexamethasone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 326}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2016-09-21', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure rates', 'timeFrame': '3 months', 'description': 'Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '3 months', 'description': 'Recurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.'}, {'measure': 'Modified Ranking Scale', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Functional outcome'}, {'measure': 'Barthel index', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Functional outcome'}, {'measure': 'Glasgow Outcome Scale', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Functional outcome'}, {'measure': 'Glasgow Coma Scale', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Functional outcome'}, {'measure': 'Markwalder score', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Functional outcome'}, {'measure': 'Clinical improvement (Categorized as resolved, improved, unchanged or worse)', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Categorized as resolved, improved, unchanged or worse'}, {'measure': 'Radiologic outcomes (Change in hematoma volume)', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Measured as change in hematoma volume'}, {'measure': 'Quality of Life measured using the EQ-5D-5L', 'timeFrame': '1, 3 and 6 months after treatment', 'description': 'Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.'}, {'measure': 'Mortality', 'timeFrame': '1, 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Subdural Hematoma']}, 'descriptionModule': {'briefSummary': 'Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. Management of cSDH is widely varied. A "wait-and-see" or "wait-and-rescan" approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors.\n\nCorticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.', 'detailedDescription': 'Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. The one-year incidence rate is 1 to 8.2 per 100 000 in those 65 years or older. Advanced age is one of several risk factors and the incidence is expected to increase due to improved life expectancy. Other risk factors include brain atrophy, chronic alcoholism, intracranial hypotension, male gender and coagulopathy (including antiplatelet and antithrombotic therapy).\n\nManagement of cSDH is widely varied. A "wait-and-see" or "wait-and-rescan" approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors.\n\nCorticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 yrs\n* subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment\n* patient must be symptomatic\n\nExclusion Criteria:\n\n* Glasgow Coma Scale (GCS) ≤ 12\n* patients needing craniotomy at the discretion of the on call neurosurgeon\n* hemiparesis with less than antigravity (≤ 3/5 medical research council scale) strength in any testable myotomes\n\n °≥ 2 seizures at presentation or history of epilepsy\n* subdural hematoma with an underlying lesion or condition such as tumor, arachnoid cyst, presence of a ventriculoperitoneal shunt or vascular malformation\n* contraindication to dexamethasone including allergy or hypersensitivity to dexamethasone, immunocompromised/immunosuppressed patients, uncontrolled diabetes, untreated known peptic ulcer disease\n* pregnant/breastfeeding mothers\n* acute infection including latent/active tuberculosis (TB)\n* history of psychosis\n* anticoagulated for mechanical heart valve or arterial stent (i.e. coronary, carotid, or peripheral) placement\n* small volume, non-operable subdural collection'}, 'identificationModule': {'nctId': 'NCT02938468', 'briefTitle': 'Mgt of Chronic Subdural Hematoma Using Dexamethasone', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial', 'orgStudyIdInfo': {'id': 'REB16-0219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'description': 'Patients in this arm will receive any form if surgical intervention (i.e. bedside burrhole craniostomy, 2 burrhole washout, craniotomy, endoscopy etc.) for treatment of their chronic subdural hematoma', 'interventionNames': ['Procedure: Any surgical intervention aim at treating chronic subdural hematoma']}, {'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'Patients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'armGroupLabels': ['Dexamethasone']}, {'name': 'Any surgical intervention aim at treating chronic subdural hematoma', 'type': 'PROCEDURE', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N1N4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Clare Gallagher, MD.,PhD', 'role': 'CONTACT', 'email': 'galclare@gmail.com', 'phone': '4039448447'}, {'name': 'Michael Opoku-Darko, MD.,MSc.', 'role': 'CONTACT', 'email': 'mopokuda@ucalgary.ca'}, {'name': 'Clare Gallagher, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Steve Casha, MD.,PhD.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Opoku-Darko, MD.,MSc.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Clare Gallagher, MD.,PhD.', 'role': 'CONTACT', 'email': 'galclare@gmail.com', 'phone': '4039448447'}, {'name': 'Michael Opoku-Darko, MD.,MSc.', 'role': 'CONTACT', 'email': 'mopokuda@ucalgary.ca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}