{ "FullStudy":{ "Rank":218182, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511666", "OrgStudyIdInfo":{ "OrgStudyId":"Prague OHCA study" }, "Organization":{ "OrgFullName":"Charles University, Czech Republic", "OrgClass":"OTHER" }, "BriefTitle":"Hyperinvasive Approach in Cardiac Arrest", "OfficialTitle":"Hyperinvasive Approach to out-of Hospital Cardiac Arrest Using Mechanical Chest Compression Device, Prehospital Intraarrest Cooling, Extracorporeal Life Support and Early Invasive Assessment Compared to Standard of Care. A Randomized Parallel Groups Comparative Study. \"Prague OHCA Study\"" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2013", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 2018", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"May 2018", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 29, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 31, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Jan Belohlavek", "ResponsiblePartyInvestigatorTitle":"Jan Belohlavek, MD, PhD., Consultant in Cardiology and Critical Care", "ResponsiblePartyInvestigatorAffiliation":"Charles University, Czech Republic" }, "LeadSponsor":{ "LeadSponsorName":"Charles University, Czech Republic", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsFDARegulatedDrug":"No", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated \"hyperinvasive\" approach might improve outcome of out-of hospital cardiac arrest victims.", "DetailedDescription":"Background: Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized study of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population with OHCA that would benefit from ECLS.\n\nAim: to perform a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, ECLS and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care.\n\nPlanned intervention: patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS by emergency medical service (EMS) team will be after fulfilling of inclusion/exclusion criteria for the study randomized in a 1:1 design to standard vs. hyperinvasive arm. Patients in standard arm will be further managed as per recent guidelines. In hyperinvasive arm, mechanical compression device together with intranasal cooling will be immediately instituted and patients will be transferred to cardiac center directly to cathlab under ongoing CPR. After admission to cathlab, overall status, ROSC and ECLS inclusion/exclusion criteria will be evaluated and in case of no contraindications to ECLS and no ROSC or ROSC with shock, veno-arterial ECLS will be started as soon as possible, not later than 60 minutes after cardiac arrest onset. After ECLS institution, mild hypothermia will be continued by means of ECLS cooling and immediate invasive investigation will be performed in all patients.\n\nStandard postresuscitation care will follow." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Out-of Hospital Cardiac Arrest" ] }, "KeywordList":{ "Keyword":[ "cardiac arrest", "mechanical chest compressions", "intraarrest cooling", "ECLS" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"170", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Hyperinvasive arm", "ArmGroupType":"Experimental", "ArmGroupDescription":"Hyperinvasive arm encompasses immediate institution of a mechanical chest compression device (LUCAS) and pre-hospital intraarrest cooling by Rhino-Chill device. Immediately after institution of these two devices the patients will be directly transferred to cardiac center cathlab under continuous CPR. The use of drugs and further defibrillations are on a discretion of the emergency physician. After admission to cathlab, overall status, ROSC presence and ECLS inclusion/exclusion criteria will be evaluated.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS" ] } },{ "ArmGroupLabel":"Standard arm", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients in standard arm will be further managed as per recent ERC guidelines, ie. continued ACLS. The use of drugs and further defibrillations are on a discretion of the emergency physician. If ROSC is attained, patients will be transferred to the same hospital to one of intensive care units, coronary angiography/PCI will be performed only if indicated according to routine practice and mild therapeutic hypothermia will be instituted as soon as possible as per recent guidelines recommendation.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Standard care" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS", "InterventionDescription":"ECLS states for extracorporeal life support.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Hyperinvasive arm" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "LUCAS", "Rhinochill", "ECLS" ] } },{ "InterventionType":"Other", "InterventionName":"Standard care", "InterventionDescription":"Standard care as per recent guidelines will be provided.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Standard arm" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Composite endpoint of survival with good neurological outcome (CPC 1-2).", "PrimaryOutcomeTimeFrame":"6 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Neurological recovery", "SecondaryOutcomeDescription":"Neurological recovery will be defined as no or minimal neurological impairment (CPC 1 or 2) at any timepoint within first 30 days after initial cardiac arrest.", "SecondaryOutcomeTimeFrame":"30 days" },{ "SecondaryOutcomeMeasure":"Cardiac recovery", "SecondaryOutcomeDescription":"Cardiac recovery will be assessed by the clinical status of hemodynamic stability defined as no need for pharmacological or mechanical cardiac support. Systolic function will be measured by echocardiography .", "SecondaryOutcomeTimeFrame":"30 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nminimum of 18 and maximum of 65 years\nwitnessed out-of-hospital cardiac arrest of presumed cardiac cause\nminimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC\nunconsciousness (Glasgow Coma Score < 8)\nECMO team and bed-capacity in cardiac center available.\n\nExclusion Criteria:\n\nOHCA of presumed non-cardiac cause\nunwitnessed collapse\npregnancy\nsustained ROSC within 5 minutes of ACLS performed by EMS team\nconscious patient\nknown bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding\nsuspected or confirmed acute stroke\nknown severe chronic organ dysfunction or other limitations in therapy\n\"do not resuscitate\" order or other circumstances making 180 day survival unlikely\nknown pre-arrest cerebral performance category CPC ≥ 3.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Jan Belohlavek, MD, PhD.", "CentralContactRole":"Contact", "CentralContactPhone":"+420 724 371 594", "CentralContactEMail":"jan.belohlavek@vfn.cz" },{ "CentralContactName":"Ondrej Smid, MD", "CentralContactRole":"Contact", "CentralContactPhone":"+420 22496 2618", "CentralContactEMail":"ondrej.smid@vfn.cz" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jan Belohlavek", "OverallOfficialAffiliation":"General University Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"General Teaching Hospital", "LocationStatus":"Recruiting", "LocationCity":"Prague", "LocationZip":"128 02", "LocationCountry":"Czech Republic", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Jan Belohlavek, MD, PhD.", "LocationContactRole":"Contact", "LocationContactPhone":"+420 724 371 594", "LocationContactEMail":"jan.belohlavek@vfn.cz" } ] } } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"22883307", "ReferenceType":"derived", "ReferenceCitation":"Belohlavek J, Kucera K, Jarkovsky J, Franek O, Pokorna M, Danda J, Skripsky R, Kandrnal V, Balik M, Kunstyr J, Horak J, Smid O, Valasek J, Mrazek V, Schwarz Z, Linhart A. Hyperinvasive approach to out-of hospital cardiac arrest using mechanical chest compression device, prehospital intraarrest cooling, extracorporeal life support and early invasive assessment compared to standard of care. A randomized parallel groups comparative study proposal. \"Prague OHCA study\". J Transl Med. 2012 Aug 10;10:163. doi: 10.1186/1479-5876-10-163." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Undecided" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006323", "ConditionMeshTerm":"Heart Arrest" },{ "ConditionMeshId":"D000058687", "ConditionMeshTerm":"Out-of-Hospital Cardiac Arrest" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M7994", "ConditionBrowseLeafName":"Heart Arrest", "ConditionBrowseLeafAsFound":"Cardiac Arrest", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M27795", "ConditionBrowseLeafName":"Out-of-Hospital Cardiac Arrest", "ConditionBrowseLeafAsFound":"Out-of-hospital Cardiac Arrest", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }