Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT05990894
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2023-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroid for Treatment of Acute/Subacute Severe 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-06', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'favorable functional outcome.', 'timeFrame': '6 months after discharge', 'description': 'mRS score ≤2 indicates favorable functional outcome.'}], 'secondaryOutcomes': [{'measure': 'Serious steroid complications during hospitalization', 'timeFrame': 'from admission to discharge (up to 4 weeks after admission)', 'description': 'new-onset of the following conditions:\n\n* lower extremity deep vein thrombosis\n* pulmonary embolism\n* gastric or duodenal ulcers\n* spontaneous fractures, osteonecrosis\n* infections or worsening of existing infections'}, {'measure': 'Serious steroids complications within 6 months after discharge', 'timeFrame': '6 months after discharge', 'description': 'new-onset of the following conditions:\n\n* Deep vein thrombosis\n* pulmonary embolism\n* gastric or duodenal ulcers\n* spontaneous fractures, osteonecrosis\n* recurrent CVT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral venous thrombosis', 'Severe cerebral venous thrombosis', 'Steroid therapy'], 'conditions': ['Cerebral Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '40033789', 'type': 'DERIVED', 'citation': 'Hu S, Gu Y, Zhao T, Zhang K, Li J, Zhou C, Song H, Liu Z, Ji X, Duan J. Steroids combined with anticoagulant in acute/subacute severe cerebral venous thrombosis. Chin Med J (Engl). 2025 Aug 5;138(15):1825-1834. doi: 10.1097/CM9.0000000000003502. Epub 2025 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The cohort study aims to evaluate the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis.', 'detailedDescription': 'Background: Evidence suggests that the inflammatory response plays a crucial role in regulating severe CVT pathogenesis. However, whether CVT patients can benefit from anti-inflammatory therapy has been debated.\n\nObjective: The objective of this cohort study is to explore the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis (CVT) patients.\n\nMethod: We reviewed the data of patients with acute/subacute severe CVT treated with a short-term application of steroid or not from a prospective stroke registry of our center. We compared functional outcomes and major adverse events at 6 months follow-up after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with acute/subacute severe CVT were enrolled in a prospective cohort at Xuanwu Hospital, Capital Medical University, between July 2020 and January 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute or subacute severe CVT, determined by the onset-to-admission time (≤ 15 days) or symptom aggravation-to-admission time (≤ 15 days) and MRI+MRV/MRBTI (MR Black-Blood Thrombus Imaging), or CT+CTV\n\nExclusion Criteria:\n\n* younger than 14 years；\n* foreign nationality；\n* receiving steroids before the onset of CVT；\n* patients with other serious diseases；\n* Presenting with neurological deficits before the onset of CVT；\n* lack of baseline data before treatment；\n* receiving steroids during hospitalization for other reasons but the dosage did not reach pulsed-therapy level\n* brain herniation but refusing to undergo decompressive craniectomy, or pupillary light reflex did not recover after decompressive craniectomy'}, 'identificationModule': {'nctId': 'NCT05990894', 'briefTitle': 'Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.', 'orgStudyIdInfo': {'id': '[2020]098'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard treatment group', 'description': 'Each patient received subcutaneous low-molecular-weight heparin in adjusted doses for 10 to 14 days, followed by oral anticoagulants (warfarin or dabigatran or rivaroxaban, if warfarin was used, PT-INR was maintained between 2.0 and 3.0) for 6 months or more. The use of endovascular treatment (local thrombectomy/thrombolysis) was reserved for patients who are still progressing with adequate anticoagulant therapy.'}, {'label': 'Steroid therapy group', 'description': 'Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy.', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'In the steroid therapy group, patients received standard treatment plus steroid therapy. Steroid therapy protocol is as follows: 500 mg methylprednisolone once a day, intravenous drip for 3 days, then reduced to 80 mg once a day, intravenous drip for 5 days, and changed to oral methylprednisolone/prednisone 1 mg per kilogram body weight, gradually tapered off by a dose of 10 mg per week.', 'armGroupLabels': ['Steroid therapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jiangang Duan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'JiangangDuan', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}