Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT03442608
Status:
UNKNOWN
Last Update Posted:
2018-02-26
First Post:
2018-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-02-15', 'lastUpdatePostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological function', 'timeFrame': '6 months after hemorrhage', 'description': "The neurological function will be evaluated at 6 months after hemorrhage by 2 specialized investigators who are unaware of the patients' allocation according to five-category Glasgow Outcome Scale as follows: 1, death; 2, vegetative state - unable to interact with the environment; 3, severe disability - unable to live independently but able to follow commands; 4, moderate disability - capable of living independently but unable to return to work or school; and 5, good recovery - able to return to work or school."}], 'secondaryOutcomes': [{'measure': 'Intracranial pressure', 'timeFrame': 'Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, until the monitor is removed', 'description': 'The effect of long-term hypothermia on ICP control will be determined.'}, {'measure': 'Length of ICU stay', 'timeFrame': '6 months post hemorrhage', 'description': 'The numbers of days in the ICU'}, {'measure': 'Length of hospital stay', 'timeFrame': '6 months post hemorrhage', 'description': 'The numbers of days in the hospital.'}, {'measure': 'Frequency of complications', 'timeFrame': '6 months post hemorrhage', 'description': 'Frequency of complications during the the study such as pneumonia, coagulation disturbance,electrolyte disturbances, liver and kidney function abnormality will be recorded and compared between groups.'}, {'measure': 'Mortality rate', 'timeFrame': '6 months after hemorrhage', 'description': 'The proportion of death will be determined'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothermia', 'Aneurysmal Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '19050656', 'type': 'BACKGROUND', 'citation': 'Seule MA, Muroi C, Mink S, Yonekawa Y, Keller E. Therapeutic hypothermia in patients with aneurysmal subarachnoid hemorrhage, refractory intracranial hypertension, or cerebral vasospasm. Neurosurgery. 2009 Jan;64(1):86-92; discussion 92-3. doi: 10.1227/01.NEU.0000336312.32773.A0.'}, {'pmid': '33987279', 'type': 'DERIVED', 'citation': 'Qu X, Shang F, Zhao H, Qi M, Cheng W, Xu Y, Jiang L, Chen W, Wang N, Zhang H. Targeted temperature management at 33 degrees Celsius in patients with high-grade aneurysmal subarachnoid hemorrhage: a protocol for a multicenter randomized controlled study. Ann Transl Med. 2021 Apr;9(7):581. doi: 10.21037/atm-20-4719.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, multi-centre, randomized,controlled trial to compare the efficacy of long-term mild hypothermia with normothermic intensive management in patients with poor-grade aneurysmal subarachnoid hemorrhage.\n\nThe primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for at least 5 days would improve the outcome of patients at six months post hemorrhage compared with normothermia.', 'detailedDescription': "Aneurysmal subarachnoid hemorrhage (aSAH), especially poor-grade aSAH, is a medical emergency with very high morbidity and mortality rates. SAH constitutes a major public health concern in developed and developing countries. There were several clinical trials of hypothermia for aSAH conducted, however, with conflicting results.\n\nHypothermia therapy treatment is currently used in our department and other large neurosurgical centers across China to decrease the intracranial pressure (ICP), mitigate some of the destructive processes, and improve the functional outcome of patients with poor-grade aSAH. When the decision was made, the patients would be placed in wrapped cooling blankets or intravascular cooling device after they were sedated, intubated and mechanically ventilated. The patients would receive continuous infusions of some drugs using an infusion pump to prevent shivering. Once the patient's rectal, nasopharyngeal or blood temperature reached 32˚C, it was kept at approximately that temperature (32-35˚C) 3 to 7 days. Then the patients were passively rewarmed to a temperature of 36 to 37˚C at a rate no greater than 0.25˚C/hour, by gradual adjustment of the blanket thermostat.\n\nThe present multi-center, randomized controlled trials is designed to investigate the efficacy and safety of long-term (3 days) mild hypothermia versus normothermia on the outcome of patients with poor-grade aSAH. The primary outcome is the neurological function assessed at 1,3, 6 months post injury with the Glasgow Outcome Score (GOS). Additionally, the following data will also be recorded and compared: the baseline data, Glasgow Coma Score,imaging examination (e.g. CT scan), intracranial pressure, laboratory tests (e.g. blood routine test, liver and kidney function, blood gas analysis, etc), the complications (e.g. pneumonia, significant bleeding) and so on."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 65 years within 72 hours after subarachnoid hemorrhage;\n* Neurosurgical clipping or coiling for aneurysm;\n* Hunt-Hess IV-V scale;\n* The intracranial pressure is more than 20 mmHg.\n\nExclusion Criteria:\n\n* GCS of 3 with bilateral fixed and dilated pupils;\n* No spontaneous breathing or cardiac arrest at the scene of hemorrhage;\n* No consent;\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03442608', 'briefTitle': 'Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'A Multi-center, Randomized, Controlled Trial to Investigate the Efficacy and Safety of Long-term Therapeutic Hypothermia in Adult Patients With Poor-grade Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'LTHSAH-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mild hypothermia', 'description': 'Device: Zoll 2000 and/or CureWrap 3500 cooling system,lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree.', 'interventionNames': ['Procedure: Zoll 2000 and/or CureWrap 3500 cooling system']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'northermia', 'description': 'normal physical cooling methods,like ice bag, conditionally required.', 'interventionNames': ['Procedure: Zoll 2000 and/or CureWrap 3500 cooling system']}], 'interventions': [{'name': 'Zoll 2000 and/or CureWrap 3500 cooling system', 'type': 'PROCEDURE', 'description': 'Device(Zoll 2000 and/or CureWrap 3500 cooling system),lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree.', 'armGroupLabels': ['mild hypothermia', 'northermia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xin Qu, MD,PhD', 'role': 'CONTACT', 'email': 'xinqu0213@126.com', 'phone': '86-10-83198633'}], 'overallOfficials': [{'name': 'Ning Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital,Capital Medical University, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Central South University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'Shanxi Cardiovascular Hospital', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Yantai Yuhuangding Hospital', 'class': 'OTHER'}, {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ning Wang', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}