Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT04613960
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Treating Subarachnoid Hemorrhage Vasospasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}], 'ancestors': [{'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evidence and TCD measured MFV indicative of vasospasm', 'timeFrame': '14 days after onset', 'description': 'Mean flow velocity measurements by TCD indicative of cerebral vasospasm. New clinical neurological deficit determined by comparing NIHSS pre and post detected vasospasm.'}], 'secondaryOutcomes': [{'measure': 'Poor MRS functional score', 'timeFrame': '3 months after the onset', 'description': 'Poor MRS score (4,5 or dead) assessed at regular follow up visits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subarachnoid hemorrhage', 'Haptoglobin', 'Vasospasm'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal', 'Cerebral Vasospasm']}, 'referencesModule': {'references': [{'pmid': '24619389', 'type': 'BACKGROUND', 'citation': 'Reddy D, Fallah A, Petropoulos JA, Farrokhyar F, Macdonald RL, Jichici D. Prophylactic magnesium sulfate for aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. Neurocrit Care. 2014 Oct;21(2):356-64. doi: 10.1007/s12028-014-9964-0.'}, {'pmid': '30409409', 'type': 'BACKGROUND', 'citation': 'Soliman R, Zohry G. [Effect of magnesium sulphate and milrinone on cerebral vasospasm after aneurysmal subarachnoid hemorrhage: a randomized study]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):64-71. doi: 10.1016/j.bjan.2018.09.005. Epub 2018 Nov 6.'}, {'pmid': '23781295', 'type': 'BACKGROUND', 'citation': 'Thomsen JH, Etzerodt A, Svendsen P, Moestrup SK. The haptoglobin-CD163-heme oxygenase-1 pathway for hemoglobin scavenging. Oxid Med Cell Longev. 2013;2013:523652. doi: 10.1155/2013/523652. Epub 2013 May 27.'}, {'pmid': '18032779', 'type': 'BACKGROUND', 'citation': 'Milman U, Blum S, Shapira C, Aronson D, Miller-Lotan R, Anbinder Y, Alshiek J, Bennett L, Kostenko M, Landau M, Keidar S, Levy Y, Khemlin A, Radan A, Levy AP. Vitamin E supplementation reduces cardiovascular events in a subgroup of middle-aged individuals with both type 2 diabetes mellitus and the haptoglobin 2-2 genotype: a prospective double-blinded clinical trial. Arterioscler Thromb Vasc Biol. 2008 Feb;28(2):341-7. doi: 10.1161/ATVBAHA.107.153965. Epub 2007 Nov 21.'}, {'pmid': '33069930', 'type': 'RESULT', 'citation': 'Ateia AM, Elbassiouny A, El-Nabi SH, Fahmy NA, Ibrahim MH, El-Garawani I, Geba KM, Khalaf M. Predictive value of haptoglobin genotype as a risk of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Clin Neurol Neurosurg. 2020 Dec;199:106296. doi: 10.1016/j.clineuro.2020.106296. Epub 2020 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.', 'detailedDescription': 'Study Design and Location:\n\nInvestigators propose a double blinded, randomized (1:1), placebo-controlled, multicenter, clinical trial including patients with acute aSAH. Participants will be allocated either to MgSO4 or placebo. The permission to conduct the study protocol will be considered for approval by the ethics committee of General Committee of Teaching Hospitals and Institutes (GCTHI), Egypt. The study will be conducted in 3 centers; El-Materia Educational Hospital, Ain Shams University Hospitals and Nasr City Insurance Hospital. The assigned centers for this study represent large-volume referral stroke centers that provide comprehensive management protocols for aSAH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders\n* age over 18 years old\n* diagnosis of acute aSAH (≤ 48 hours) confirmed with angiographic evidence of cerebral aneurysm and CT brain on admission.\n\nExclusion Criteria:\n\n* subarachnoid hemorrhage due to non-aneurysmal causes\n* cerebral stroke of any type during past month\n* decompensated heart failure, renal failure or hepatic failure\n* difficult bilateral transtemporal transcranial Doppler (TCD) insonation of intracranial arteries due to thick temporal bone of the skull.'}, 'identificationModule': {'nctId': 'NCT04613960', 'acronym': 'MATSH-SHapE', 'briefTitle': 'Magnesium Treating Subarachnoid Hemorrhage Vasospasm', 'organization': {'class': 'OTHER_GOV', 'fullName': 'General Committee of Teaching Hospitals and Institutes, Egypt'}, 'officialTitle': 'Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MTH/NEUR/20/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium arm', 'description': 'patients randomized to magnesium therapy at a fixed daily dose of 64 mmol reconstituted in 0.9% saline via continuous intravenous infusion for 14 days after hemorrhage onset, or until discharge or death if it occurred.', 'interventionNames': ['Drug: Magnesium sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'patients randomized to placebo therapy with 0.9% saline (without active component) via same protocol.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Magnesium sulfate', 'type': 'DRUG', 'description': 'MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset', 'armGroupLabels': ['Magnesium arm']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Placebo treatment', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M Ateia', 'role': 'CONTACT'}], 'facility': 'El matareya Educational Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed M Ateia', 'role': 'CONTACT', 'email': 'a_ateia@hotmail.com', 'phone': '+201202474777'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Committee of Teaching Hospitals and Institutes, Egypt', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}, {'name': 'Health Insurance Organization, Egypt', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurology Specialist, MTH; Associate member, Harvard Medical School.', 'investigatorFullName': 'Ahmed Mohammed Ateia', 'investigatorAffiliation': 'General Committee of Teaching Hospitals and Institutes, Egypt'}}}}