Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-03 @ 3:53 PM
Study NCT ID:
NCT02192320
Status:
UNKNOWN
Last Update Posted:
2015-03-26
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
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': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of hematoma volume', 'timeFrame': '2,5,12 weeks during treatment', 'description': "After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up."}], 'secondaryOutcomes': [{'measure': 'Outcome score (GOSE) in subjects', 'timeFrame': '2,5,12 weeks during treatment'}, {'measure': 'Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis', 'timeFrame': '2,5,12 weeks during treatment'}, {'measure': 'Changes of neurological symptoms and signs', 'timeFrame': '2,5,12 weeks during treatment'}, {'measure': 'Recurrence and prognosis of patient failure in those conservative treatment', 'timeFrame': '2,5,12 weeks during treatment'}, {'measure': 'Outcome score (ADL-BI Scale) in subjects', 'timeFrame': '2,5,12 weeks during treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atorvastatin', 'Atorvastatin and Dexamethasone', 'Chronic Subdural Hematoma', 'conservative treatment'], 'conditions': ['Chronic Subdural Hematoma']}, 'descriptionModule': {'briefSummary': 'To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders', 'detailedDescription': 'Study design: Two-arm,Evaluator-blinded study\n\nSubjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted）\n\nSample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 and\\<90years old, both gender;\n2. Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;\n3. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);\n4. The midline shift to less than 1 cm;\n5. Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;\n6. Patients have never undergo surgery on the hematoma;\n7. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.\n\nExclusion Criteria:\n\n1. Allergic to the statin and dexamethasone or its ingredients;\n2. Hematoma caused by tumors, blood and other known comorbidities;\n3. Abnormal liver function;\n4. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study;\n5. Patients have been on oral Statin treatment in the past four weeks;\n6. Patients have been on oral Steroids treatment for a long time;\n7. Diagnosed Diabetes patients with poorly controlled blood glucose\n8. Participate in clinical trials in the past four weeks;\n9. Pregnant or breastfeeding;\n10. Failure of completing the trial by poor compliance;\n11. For any reason, the researchers believe that the case is not suitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT02192320', 'briefTitle': 'The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Oriental Neurosurgery Evidence-Based-Study Team'}, 'officialTitle': 'The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders', 'orgStudyIdInfo': {'id': 'CSDH2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atorvastatin and Dexamethasone', 'description': 'Atorvastatin: 20 mg (every evening orally) for 5 weeks;\n\nDexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)', 'interventionNames': ['Drug: Atorvastatin and Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'Atorvastatin: 20 mg (every evening orally) for 5 weeks', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'description': '20 mg (every evening orally) for 5 weeks', 'armGroupLabels': ['Atorvastatin']}, {'name': 'Atorvastatin and Dexamethasone', 'type': 'DRUG', 'description': 'Atorvastatin: 20 mg (every evening orally) for 5 weeks;\n\nDexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)', 'armGroupLabels': ['Atorvastatin and Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Rongcai Jiang, PhD', 'role': 'CONTACT', 'email': 'jianghope@gmail.com', 'phone': '86-22-60814348'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oriental Neurosurgery Evidence-Based-Study Team', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}