Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT01607151
Status:
UNKNOWN
Last Update Posted:
2015-08-05
First Post:
2012-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility Study of Targeted Temperature Management After ICH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], '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'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-04', 'studyFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2012-05-25', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe adverse events (SAEs)', 'timeFrame': '90 days', 'description': 'The primary outcome measures will be: a) the frequency of adverse events (AEs) that will be possibly or probably related to treatment. AEs will be assessed up to 15-days after admission or discharge if earlier, and b) the frequency of severe adverse events (SAEs) that will be possibly and probably related to treatment.'}], 'secondaryOutcomes': [{'measure': 'In-hospital neurological deterioration between day 0-7', 'timeFrame': '7 days', 'description': 'Decrease in GCS in ≥2 points or increase in the NIHSS ≥4 points'}, {'measure': 'Functional outcome', 'timeFrame': 'Discharge and 90 days', 'description': 'Modified Rankin Scale at discharge and 90-days.'}, {'measure': 'Hematoma growth', 'timeFrame': '24 hours', 'description': 'Absolute change in hematoma between baseline and 24 hours CT-scan and new or absolute change in IVH between baseline and 24 hours CT-scan'}, {'measure': 'Cerebral edema', 'timeFrame': '24, 48,72, and 168-hours', 'description': 'The absolute change in cerebral edema and the relative change in cerebral edema (absolute edema/absolute ICH volume unit less ratio)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypothermia', 'normothermia', 'hyperthermia'], 'conditions': ['Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited experience with the use of TTM after intracerebral hemorrhage (ICH), the most devastating type of stroke. TTM may be a an intervention to improve patient outcomes. This trial addresses the safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may be the basis for future larger clinical trials.', 'detailedDescription': 'Morbidity and mortality from intra-cerebral/intra-parenchymal hemorrhage (ICH/IPH) are important public health problems. As the most common etiology of ICH/IPH is hypertension, this places a large proportion of the population at risk. In 2011 The American Heart Association (AHA) estimated that in the US, there were 610,000 new stroke cases of which 10% were ICHs, and many required long-term health care. ICH/IPH is associated with the highest morbidity and mortality and only 20% of patients regain functional independence. Temperature modulation to hypothermia (T, 32-34°C) has been associated with modulation of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. Currently, there are no therapies to specifically target ICH/IPH. To this end, novel strategies that go beyond control of glucose, blood pressure, and intra-cranial pressure, aimed at reducing the enlargement of the hematoma and "swelling" surrounding it, could be "the new frontier in the management of ICH/IPH". Since the early resuscitation phase in the Neuro-ICU represents the greatest opportunity for impact on clinical outcome after ICH/IPH, it also appears to be the most promising window of opportunity to demonstrate a benefit when investigating novel therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spontaneous supratentorial ICH documented by CT scan within 18 hours after the onset of symptoms\n* Admission to the Neuro-ICU\n* Baseline hematoma \\>15cc with or without IVH\n* Need for mechanical ventilation.\n\nExclusion Criteria:\n\n* GCS \\<6\n* Age \\<18 years\n* Pregnancy\n* Pre-morbid modified Rankin Scale (mRS) \\>2\n* Do Not Resuscitate (DNR) order "prior" to enrollment\n* Uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding \\[UGIB/LGIB\\])\n* Planned surgical decompression within 24 hours\n* Secondary causes of ICH (ischemic stroke, coagulopathy \\[INR\\>1.4, aPTT\\> 1.5 times baseline, thrombocytopenia platelets \\<100,000/uL\\], trauma, AVM, aneurysm, cerebral sinus thrombosis, or other causes)\n* Evidence of sepsis\n* Spontaneous hypothermia (core Temperature \\<36C)\n* Inability to obtain written informed consent\n* Participation in another trial.'}, 'identificationModule': {'nctId': 'NCT01607151', 'acronym': 'TTM-ICH', 'briefTitle': 'Safety and Feasibility Study of Targeted Temperature Management After ICH', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage', 'orgStudyIdInfo': {'id': '12CRP12050342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normothermia', 'description': 'Core temperature 36-37 C', 'interventionNames': ['Other: Normothermia']}, {'type': 'EXPERIMENTAL', 'label': 'Hypothermia', 'description': 'Core temperature 32-34 C', 'interventionNames': ['Other: Hypothermia']}], 'interventions': [{'name': 'Normothermia', 'type': 'OTHER', 'description': '72 hours of targeted temperature management to achieve normothermia (36-37°C)', 'armGroupLabels': ['Normothermia']}, {'name': 'Hypothermia', 'type': 'OTHER', 'description': '72 hours of targeted temperature management to achieve hypothermia (32-34°C)', 'armGroupLabels': ['Hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Fred Rincon, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}