Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-06 @ 8:09 AM
Study NCT ID:
NCT02011568
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2013-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
Sponsor:
Organization:
Raw JSON
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Neurologic outcome will be assessed by a specialist in rehabilitation medicine using the Disability Ratings Scale (DRS. Patients will be judged to have had a poor neurologic outcome if the score on the DRS scale is \\>5.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days and 6 months', 'description': 'All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'title': '30 days', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days and 6 months', 'description': 'Stroke will be classified as hemorrhagic versus non-hemorrhagic.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During index hospitalization, up to 40 days', 'description': 'Bleeding will be assessed using the TIMI definition and will be scored as major or minor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay in the Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '15'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission to unit to discharge from unit', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay in the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '30'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission to hospital to discharge from hospital.', 'description': 'The length of stay participant was in hospital (day of admission to day of discharge from facility)', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiogenic Shock', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission)', 'description': 'The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Six months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During index hospitalization (*up to 45 days post admission day while in hospital)', 'description': 'Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Renal Failure Requiring Renal Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During index hospitalization - day of admission up to 45 days post admission while in hospital', 'description': 'Participants who required renal replacement therapy (e.g. CRRT, IHD)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Ventilator Associated Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During index hospitalization - from day of admission up to 45 days post admission (while in hospital)', 'description': 'The number of participants who developed ventilator associated pneumonia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of their admission', 'description': 'Participants who are diagnosed with stent thrombosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discharged Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'OG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Six months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Survivors discharged to home from hospital.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'FG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '183'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients with out-of-hospital cardiac arrest surviving to hospital admission and referred for post-cardiac arrest care were recruited.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Moderate Hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius\n\nTherapeutic Hypothermia'}, {'id': 'BG001', 'title': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius\n\nTherapeutic Hypothermia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '61.7', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-03-22', 'size': 752683, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-03T13:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2013-11-08', 'resultsFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Death or Poor Neurologic Outcome at 6 Months', 'timeFrame': 'Six months', 'description': 'The primary outcome of the study will be death or poor neurologic outcome at six months. Neurologic outcome will be assessed by a specialist in rehabilitation medicine using the Disability Ratings Scale (DRS. Patients will be judged to have had a poor neurologic outcome if the score on the DRS scale is \\>5.'}], 'secondaryOutcomes': [{'measure': 'Number of Mortality', 'timeFrame': '30 days and 6 months', 'description': 'All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.'}, {'measure': 'Number of Participants With Stroke', 'timeFrame': '30 days and 6 months', 'description': 'Stroke will be classified as hemorrhagic versus non-hemorrhagic.'}, {'measure': 'Number of Participants With Bleeding', 'timeFrame': 'During index hospitalization, up to 40 days', 'description': 'Bleeding will be assessed using the TIMI definition and will be scored as major or minor.'}, {'measure': 'Length of Stay in the Unit', 'timeFrame': 'Admission to unit to discharge from unit'}, {'measure': 'Length of Stay in the Hospital', 'timeFrame': 'Admission to hospital to discharge from hospital.', 'description': 'The length of stay participant was in hospital (day of admission to day of discharge from facility)'}, {'measure': 'Number of Participants With Cardiogenic Shock', 'timeFrame': 'During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission)', 'description': 'The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility)'}, {'measure': 'Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)', 'timeFrame': 'Six months'}, {'measure': 'Number of Participants With Seizures', 'timeFrame': 'During index hospitalization (*up to 45 days post admission day while in hospital)', 'description': 'Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility)'}, {'measure': 'Number of Participants With Renal Failure Requiring Renal Replacement Therapy', 'timeFrame': 'During index hospitalization - day of admission up to 45 days post admission while in hospital', 'description': 'Participants who required renal replacement therapy (e.g. CRRT, IHD)'}, {'measure': 'Number of Participants With Ventilator Associated Pneumonia', 'timeFrame': 'During index hospitalization - from day of admission up to 45 days post admission (while in hospital)', 'description': 'The number of participants who developed ventilator associated pneumonia'}, {'measure': 'Number of Participants With Stent Thrombosis', 'timeFrame': 'Within 6 months of their admission', 'description': 'Participants who are diagnosed with stent thrombosis'}, {'measure': 'Number of Participants Discharged Home', 'timeFrame': 'Six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Therapeutic Hypothermia', 'Out of hospital cardiac arrest', 'Mild hypothermia', 'Moderate hypothermia'], 'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '34665203', 'type': 'DERIVED', 'citation': 'Le May M, Osborne C, Russo J, So D, Chong AY, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, De Roock S, Labinaz M, Bernick J, Marshall S, Maze R, Wells G. Effect of Moderate vs Mild Therapeutic Hypothermia on Mortality and Neurologic Outcomes in Comatose Survivors of Out-of-Hospital Cardiac Arrest: The CAPITAL CHILL Randomized Clinical Trial. JAMA. 2021 Oct 19;326(15):1494-1503. doi: 10.1001/jama.2021.15703.'}]}, 'descriptionModule': {'briefSummary': 'This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The plan is to expand the trial shortly as a multi-center project. The patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC defined as the resumption of sustained perfusing cardiac activity.\n\nThe primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Out of hospital cardiac arrest patient\n2. Return of spontaneous circulation\n3. Glasgow Coma Score equal or lesser than 8.\n\nExclusion Criteria:\n\n1. Patients residing in a Nursing Home or patients unable to reside independently,\n2. Intracranial bleed responsible for the cardiac arrest,\n3. Severe coagulopathy with clinical evidence of major bleeding,\n4. Coma that is not attributable to cardiac arrest,\n5. Pregnancy,\n6. Life expectancy of \\< one year due to any cause unrelated to the cardiac arrest,\n7. Known coagulation disorder (i.e. INR \\>2.0, platelets \\<100,000 / mm3),\n8. Participation in a study with another investigational device or drug \\< four weeks,\n9. The Endovascular cooling (ZOLL) device is not available.'}, 'identificationModule': {'nctId': 'NCT02011568', 'acronym': 'CAPITALCHILL', 'briefTitle': 'Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)', 'orgStudyIdInfo': {'id': '2013106-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Moderate hypothermia', 'description': 'Therapeutic hypothermia at 31 degrees celsius', 'interventionNames': ['Other: Therapeutic Hypothermia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mild Hypothermia', 'description': 'Therapeutic Hypothermia at 34 degrees Celsius', 'interventionNames': ['Other: Therapeutic Hypothermia']}], 'interventions': [{'name': 'Therapeutic Hypothermia', 'type': 'OTHER', 'armGroupLabels': ['Mild Hypothermia', 'Moderate hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'k1y 4w7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Michel R Le May, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}