Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05858060
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2023-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020206', 'term': 'Subarachnoid Hemorrhage, Traumatic'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'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': 'D020214', 'term': 'Cerebrovascular Trauma'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'regular blood sample for examination of regular blood chemicals'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-12', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin score', 'timeFrame': '1 month after ictus', 'description': 'The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead.'}, {'measure': 'modified Rankin score', 'timeFrame': '6 months', 'description': 'The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome'], 'conditions': ['Subarachnoid Hemorrhage, Traumatic']}, 'referencesModule': {'references': [{'pmid': '40713038', 'type': 'DERIVED', 'citation': 'Jiang L, Qi M, Xu Y, Qu X, Chen W, Cheng W, Zhao H, Shang F, Fu X, Wang C, Jiang R, Wang N. Hyperosmolar therapy for severe subarachnoid haemorrhage: a protocol for a multicentre prospective observational study (OSMO-SAH study). BMJ Open. 2025 Jul 25;15(7):e099008. doi: 10.1136/bmjopen-2025-099008.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question\\[s\\] it aims to answer are:\n\n• whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients?\n\nParticipants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who meet inclusion and exclusion criterias will be consecutively included. Treatment will be given according to expert consensus of local center, including neurosurgical and intensive management.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ①age ≥18； ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5级\n\nExclusion Criteria:\n\n* previous cranial decompression surgery, cerebrospinal fluid leakage or drainage,\n\n * bilateral pupils fixed or dilated,\n\n * hemodynamic instability,\n\n * hemoglobin \\< 8g / L,\n\n * serum osmolality \\> 320 mOsm / L,\n\n ⑥ combined with severe organ dysfunction (cardiac, pulmonary, hepatic, renal and so on);\n\n ⑦ serious electrolyte disorders (serum sodium concentration \\<125 mmol / L or \\>170 mmol / L), and difficult to correct within limited time;\n\n ⑧ serious acid-base balance disorders, and difficult to correct within limited time;\n\n ⑨ use of mannitol or HSS within previous six hours;\n\n ⑩ being pregnant.'}, 'identificationModule': {'nctId': 'NCT05858060', 'acronym': 'OSMO-SAH', 'briefTitle': 'Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Practice of Osmotherapy in Severe SubArachnoid Hemorrhage Patients: Multicenter Observational Study (OSMO-SAH Study)', 'orgStudyIdInfo': {'id': 'XWNeurosurgicalICU'}}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lidan Jiang, Dr.', 'role': 'CONTACT', 'email': 'jianglidan@xwhosp.org', 'phone': '+8615101597091'}, {'name': 'Lidan Jiang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lidan Jiang', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}