[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549078":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":67,"locations":76,"responsibleParty":851,"collaborators":853,"id":857,"slug":858,"hasResults":859,"nctId":860,"briefTitle":861,"officialTitle":862,"acronym":863,"eligibilityCriteria":864,"healthyVolunteers":859,"sex":865,"minAge":866,"maxAge":38,"enrollmentInfo":867,"targetDuration":38,"studyType":870,"phases":871,"briefSummary":873,"conditions":874,"keywords":880,"overallStatus":79,"whyStopped":38,"lastUpdateSubmitDate":891,"lastUpdatePostDateStruct":892,"startDateStruct":895,"completionDateStruct":897,"leadSponsor":899,"locationsCount":900},{"fullName":5,"class":6},"Region Skane","OTHER",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","ACTIVE_COMPARATOR","A range of implementation methods will be used to introduce an active Care Bundle with time- and target-based metrics that involve the rapid correction of abnormal physiological variables over days or hospital discharge (or death, if sooner) and referral pathways",[13,14,15,16,17,18,19,20],"Other: Reversal of Oral anticoagulation within 30 minutes","Other: Early intensive blood pressure lowering","Other: Treatment of pyrexia","Other: Hyperglycemia treatment","Other: Do-not-resuscitate (DNR) or withdrawal of care","Other: Referral to Intensive Care","Other: Referral to Neurosurgery","Diagnostic Test: Repeat brain imaging",{"label":22,"type":23,"description":24,"interventionNames":25},"Usual care","PLACEBO_COMPARATOR","For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.",[26],"Other: Standard care",[28,34,39,43,47,51,55,59,64],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Reversal of Oral anticoagulation within 30 minutes","In situations of either an elevated INR with the use of warfarin - treatment with either 3- or 4-factor prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) within 30 minutes of ICH diagnosis on NCCT to reach and maintain an INR target \\\u003C1.3; or where there has been recent use (\\\u003C48 hours) of a direct oral anticoagulant (DOAC), use of an appropriate reversal agent within 30 minutes, where available, and according to local approvals.",[9],[33],"OAC reversal",{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Early intensive blood pressure lowering","A systolic blood pressure (BP) target of 130-140 mmHg within 30 minutes of ICH diagnosis on NCCT is strived for, and to maintain this BP level for the first 7 days (for patients presenting with blood pressure \\\u003C200 mmHg). If blood pressure ≥200 and \\\u003C220, a target BP of 160 mmHg should be targeted at 30 minutes, and 130-140 mmHg should be achieved in 60 minutes. If BP ≥220, target BP of 160 mmHg and should be achieved in 60 minutes.",[9],null,{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Treatment of pyrexia","To achieve a body temperature target \\\u003C37.5 °C within the first 24h following ICH diagnosis on NCCT",[9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":38},"Hyperglycemia treatment","To maintain a blood glucose level 7-10 mmol\u002FL within the first 24h following ICH diagnosis on NCCT",[9],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":38},"Do-not-resuscitate (DNR) or withdrawal of care","Refrain from the use of DNR or withdrawal of care orders for 48 hours",[9],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":38},"Referral to Intensive Care","Immediate (\\\u003C30 min) referral to intensive care if airway, breathing and\u002For circulation are compromized",[9],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":38},"Referral to Neurosurgery","Immediate (\\\u003C30 min) referral to neurosurgery if any of the following criteria are fulfilled:\n\n* Large and\u002For rapidly evolving supratentorial ICH (\\>20 ml volume)\n* Any intraventricular extension\n* Posterior fossa bleed, irrespective of volume\n* Suspicion of a vascular malformation, independent of volume or location\n* Reduction in reaction to sensory stimulation or drowsiness",[9],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":38},"DIAGNOSTIC_TEST","Repeat brain imaging","Repeat 6-12-hour brain imaging with the physicians choice of modality, preferably computed tomography (CT), if clinical deterioration or the patient received OAC reversal treatment",[9],{"type":6,"name":65,"description":24,"armGroupLabels":66,"otherNames":38},"Standard care",[22],[68,73],{"name":69,"role":70,"phone":71,"phoneExt":38,"email":72},"Teresa Ullberg, MD, PhD","CONTACT","0046175057","i-catcher@med.lu.se",{"name":74,"role":70,"phone":38,"phoneExt":38,"email":75},"Trine Apostolaki-Hansson, MD PhD","trine.apostolaki-hansson@med.lu.se",[77,96,112,126,143,161,176,190,204,219,237,253,266,283,297,313,327,343,357,367,382,397,410,424,438,452,464,478,492,509,523,537,551,566,578,593,607,620,634,649,663,677,688,697,708,723,737,754,768,779,793,810,823,836],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"The University of Oklahoma Health","RECRUITING","Oklahoma City","Oklahoma","73126-0901","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-97.51643,35.46756,{"lat":89,"lon":88},[92],{"name":93,"role":70,"phone":94,"phoneExt":38,"email":95},"Faddi G. 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Vass","46102410000","melania.vass@rjl.se",{"facility":344,"status":79,"city":345,"state":38,"zip":346,"country":331,"countryCode":332,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Sahlgrenska Universitetssjukhuset","Gothenburg","413 45",{"type":86,"coordinates":348},[349,350],11.96679,57.70716,{"lat":350,"lon":349},[353],{"name":354,"role":70,"phone":355,"phoneExt":38,"email":356},"Petra Redfors, MD","46313421000","petra.redfors@vgregion.se",{"facility":358,"status":79,"city":345,"state":38,"zip":359,"country":331,"countryCode":332,"cosmosGeoPoint":360,"geoPoint":362,"contacts":363},"Östra Sjukhuset","41685",{"type":86,"coordinates":361},[349,350],{"lat":350,"lon":349},[364],{"name":365,"role":70,"phone":355,"phoneExt":38,"email":366},"Christina Heden Ståhl","christina.heden-stahl@vgregion.se",{"facility":368,"status":79,"city":369,"state":38,"zip":38,"country":331,"countryCode":332,"cosmosGeoPoint":370,"geoPoint":374,"contacts":375},"Hässleholms 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tumor or cerebral venous thrombosis\n* Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils)\n* Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.","ALL","18 Years",{"count":868,"type":869},3500,"ESTIMATED","INTERVENTIONAL",[872],"PHASE4","Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. 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The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.",[875,876,877,878,879],"Intracerebral Hemorrhage","Intracerebral Haemorrhage","Intraventricular Hemorrhage","Stroke","Cerebrovascular Disease",[881,882,883,884,885,886,887,888,889,890],"intracerebral hemorrhage","oral anticoagulant","blood pressure lowering","early intensive blood pressure lowering","care bundle","implementation study","reversal treatment","outcome","UW-mRS","Modified Rankin Scale","2026-05-20",{"date":893,"type":894},"2026-05-22","ACTUAL",{"date":896,"type":894},"2025-01-07",{"date":898,"type":869},"2027-07",{"name":5,"class":6},54]