Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT01584167
Status:
UNKNOWN
Last Update Posted:
2013-06-24
First Post:
2012-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'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': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077331', 'term': "Ringer's Solution"}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2012-04-21', 'studyFirstSubmitQcDate': '2012-04-21', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain temperature', 'timeFrame': '-15 to +60min', 'description': 'Primary endpoint: Change of brain temperature during one hour after start of cooling. Repeated measurement ANOVA for within subject contrasts (phase 1 (0 to 15min), 2 (15 to 30min), 3 (30 to 45min) and 4 (45 to 60min)) vs. baseline (-15 to 0min)'}], 'secondaryOutcomes': [{'measure': '(Neuro-)vital parameters', 'timeFrame': '-15 to +180 min', 'description': 'Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered'}, {'measure': 'Cerebral autoregulation', 'timeFrame': '15 to +180 min', 'description': 'Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.'}, {'measure': 'Safety', 'timeFrame': '0 - 7 days', 'description': 'Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypothermia', 'induction of hypothermia', 'cold infusion', 'whole-body cooling', 'external cooling', 'surface cooling', 'non invasive cooling', 'stroke', 'intracranial hemorrhage', 'cerebrovascular disease', 'neuro intensive care'], 'conditions': ['Ischemic Stroke', 'Hemorrhagic Stroke']}, 'descriptionModule': {'briefSummary': 'Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sedation\n* Combined ICP-temperature-probe\n* Indication to lower body temperature \\> 1.5°C\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Body weight \\> 120 kg\n* Severe renal insufficiency\n* Acute pulmonary embolism\n* Acute myocardial infarction\n* High-grade heart valve stenosis or insufficiency\n* Severe cardiac insufficiency (NYHA ≥ III)\n* Threatening ventricular dysrhythmia\n* Cardiac dysrhythmia with bradycardia (heart rate \\< 45 /min, QTc \\> 450 ms, sick sinus syndrome, AV-block II-III°).\n* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)\n* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)\n* Skin lesions not allowing a secure application of the EMCOOLS Flex.Pads"}, 'identificationModule': {'nctId': 'NCT01584167', 'acronym': 'iCOOL 2', 'briefTitle': 'A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'iCOOL 2 (Induction of COOLing 2): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads', 'orgStudyIdInfo': {'id': 'iCOOL 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cold infusions', 'description': 'Infusion of 2L cold crystalloid solution (4°C) over 30 minutes', 'interventionNames': ["Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EMCOOLS Flex.Pads', 'description': 'Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria)', 'interventionNames': ['Device: EMCOOLS Flex.Pads']}], 'interventions': [{'name': "Cold crystalloid infusions, 0.9%NaCl or Ringer's solution", 'type': 'DRUG', 'description': 'Infusion of 2L cold crystalloid solution (4°C) over 30 minutes', 'armGroupLabels': ['Cold infusions']}, {'name': 'EMCOOLS Flex.Pads', 'type': 'DEVICE', 'otherNames': ['Emergency Medical Cooling Systems AG, Wien, Austria'], 'description': 'Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads', 'armGroupLabels': ['EMCOOLS Flex.Pads']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sven Poli, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jan C Purrucker, Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Sven Poli, Dr. med.', 'role': 'CONTACT', 'email': 'sven.poli@med.uni-heidelberg.de', 'phone': '0049 6221 56', 'phoneExt': '0'}], 'overallOfficials': [{'name': 'Sven Poli, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Sven Poli, Consultant Neurologist, Principical Investigator', 'investigatorFullName': 'Dr. Sven Poli', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}