Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT04555460
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007238', 'term': 'Infarction'}], 'ancestors': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019299', 'term': 'Decompression, Surgical'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2008-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin score 0-3', 'timeFrame': '1 year', 'description': 'Slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '1 year', 'description': 'Death at 6 month and 1 year'}, {'measure': 'Barthel Index', 'timeFrame': '1 year', 'description': 'measured12 months after randomization (defined by a score of 0 to 100; as 100 being the best)'}, {'measure': 'National Institute of Health Stroke Scale (NIHSS)', 'timeFrame': '1 year', 'description': 'measured12 months after randomization (The maximum possible score is 42, with the minimum score being a 0)'}, {'measure': 'Stroke Impact Scale 2.0 (SIS)', 'timeFrame': '1 year', 'description': 'The score of each domain was calculated as 100 being the best, with a range of 0-100.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infarction, hemicraniectomy'], 'conditions': ['Cerebral Herniation']}, 'descriptionModule': {'briefSummary': 'This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. We randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to 83) with malignant middle cerebral artery infarction to either conservative medical treatment or hemicraniectomy; assignments were made within 12 to 38 hours after the onset of symptoms. The primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale, which ranges from 0 \\[no symptoms\\] to 6 \\[death\\]). Secondary outcome included death, Barthel Index, National Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) 6 months and 1 year after randomization. Variables for subgroup analyses were age, sex, presence of aphasia or neglect, stroke severity and time to randomization. The study was performed according to Consolidated Standards of Reporting Trials (CONSORT).', 'detailedDescription': 'Patients between 40 to 80 years of age were included within 12 to 38 hours of a malignant middle cerebral artery infarction defined by the association of 3 criteria: a National Institutes of Health Stroke Scale score ≥16, including a score ≥1 for item 1a (level of consciousness); brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory; and a diffusion-weighted imaging (DWI) infarct volume \\>150cm3. The first patient was enrolled in January 2003 and the last patient in December 2007. An independent data safety monitoring committee monitored the safety, progress, and ethics of the trial. Patients were randomized to either surgical plus medical treatment or to conservative medical treatment alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A National Institutes of Health Stroke Scale score ≥16\n* A score ≥1 for item 1a (level of consciousness)\n* Brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory\n* Diffusion-weighted imaging infarct volume \\>150cm3\n\nExclusion Criteria:\n\n* Prestroke modified Rankin score score ≥2\n* Prestroke score on the Barthel Index \\<95\n* Score on the Glasgow Coma Scale \\<6\n* Both pupils fixed and dilated\n* Any other coincidental brain lesion that might affect outcome\n* Plasminogen activator in the 12 h before randomisation\n* Space-occupying hemorrhagic transformation of the infarct\n* Pregnancy\n* Life expectancy \\<3 years\n* Other serious illness that might affect outcome\n* Known coagulopathy or systemic bleeding disorder\n* Contraindication for anesthesia'}, 'identificationModule': {'nctId': 'NCT04555460', 'briefTitle': 'Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction: A Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '2003/44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Decompressive surgery', 'description': 'Decompressive surgery was performed with a large hemicraniectomy that removed, ipsilateral to the stroke, a bone flap as large as possible including temporal, frontal, parietal, and some occipital squama.', 'interventionNames': ['Procedure: Hemicraniectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative medical therapy', 'description': 'Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke. Administration of intravenous mannitol (0.25 to 0.5 g/kg) or furosemide was given only in patients whose condition was rapidly worsening because of brain edema, without additional recommendations on loading doses.', 'interventionNames': ['Other: Conservative medical therapy']}], 'interventions': [{'name': 'Hemicraniectomy', 'type': 'PROCEDURE', 'otherNames': ['Surgical decompression'], 'description': 'Large hemicraniectomy and duraplasty', 'armGroupLabels': ['Decompressive surgery']}, {'name': 'Conservative medical therapy', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke', 'armGroupLabels': ['Conservative medical therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Timur Köse, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biostatistic Department, Ege University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '3 months after publication data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. MD', 'investigatorFullName': 'Prof. Dr. Emre Kumral', 'investigatorAffiliation': 'Ege University'}}}}