[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565914":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":62,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":24,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Control arm (usual care)","Control group is treated according to local standard of care",[12],"Other: Standard of care",{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental arm (MAX-ICH care bundle)","EXPERIMENTAL","Experimental group is treated according MAX-ICH care bundle",[18],"Other: MAX-ICH care bundle",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"MAX-ICH care bundle","The MAX-ICH care bundle is a comprehensive treatment approach for intracerebral hemorrhage (ICH). Patients receive 72 hours of care in a high-dependency unit like an ICU or hyperacute stroke unit. Intensive blood pressure control is used if systolic blood pressure exceeds 140mmHg, with rapid reduction to below 140mmHg within 60 minutes, and maintenance at or above 110mmHg for at least 75% of the time, with variability kept under 20%. The protocol includes rapid reversal of anticoagulation within 60 minutes, administration of tranexamic acid (1g bolus within 60 minutes, followed by 1g over 8 hours), and neurosurgical evaluation within 60 minutes. Additionally, family counseling is provided to avoid Do-Not-Resuscitate orders during the first 72 hours.",[14],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Standard of care","The control group will be treated according to the hospital's standard protocol for patients with spontaneous intracerebral hemorrhage, based on the guidelines of the European Stroke Organisation (ESO). The ESO develops evidence-based recommendations for the optimal care of stroke patients. The recommended immediate measures include: immediate stabilization and assessment, blood pressure control and reduction, brain imaging, surgical intervention for large hemorrhages, coagulation control, and monitoring of intracranial pressure. The specific application of these measures varies depending on the hospital and the treating physicians.",[9],[30],{"name":31,"affiliation":32,"role":33},"David J Seiffge, Prof. Dr. med.","Department for Neurology, Inselspital, University Hospital Bern","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","+41 31 66 40 509","david.seiffge@insel.ch",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Bernhard M Siepen, Dr. med.","+41 31 63 24 220","bernhard.siepen@insel.ch",[44],{"facility":45,"status":46,"city":47,"state":24,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Inselspital, University Hospital Bern","RECRUITING","Bern","3010","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],7.44744,46.94809,{"lat":55,"lon":54},[58,60],{"name":31,"role":36,"phone":59,"phoneExt":24,"email":38},"+41 31 664 05 09",{"name":40,"role":36,"phone":61,"phoneExt":24,"email":42},"+41 31 632 89 61",{"type":63,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100565914","maximal-medical-treatment-of-intracerebral-haemorrhage-pilot-trial---max-ich-pilot-trial-100565914",false,"NCT06648369","Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial","MAX-ICH","Inclusion Criteria:\n\n* Symptomatic imaging proven diagnosis of non-traumatic ICH\n* Vascular imaging (MR-\u002FCT-angiogram or DSA) on admission to rule out high suspicion of macrovascular bleeding source\n* Enrolment no later than 6 hours of symptom onset\n* Age \\>18 years, no upper age limit\n* Informed consent as documented by signature or fulfilling the criteria for emergency consent\u002F deferral consent\n\nExclusion Criteria:\n\n* Palliative care\u002Fcomfort therapy decision in the emergency department\n* ICH due to trauma (major head trauma \\\u003C24 hours of symptom onset causing loss of consciousness and thought to be sufficient to have caused the intracerebral bleeding)\n* High suspicion of ICH due to arteriovenous malformation (AVM), aneurysm or sinus-venous-thrombosis confirmed by neuroimaging, brain tumor, vasculitis, RCVS\u002FPRES or system disease (liver disease, inherit coagulopathy)\n* Severe ICH (haematoma volume \\>60ml or GCS \\\u003C8)\n* Haematoma evacuation or decompressive craniectomy within 72 hours planned or highly likely (isolated EVD is not an exclusion criterion)\n* Severe pre-morbid disability \\[modified Rankin scale (mRS) is ≥4\\]\n* Contraindication against the use of tranexamic acid\n* Active participation in another drug or devices trial concurrently\n* Female patient that are either pregnant or breastfeeding\n* Contraindications against Clevidipine (allergy to soja, lipid metabolism defect or known severe aortic stenosis)","ALL","18 Years","100 Years",{"count":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"NA","The MAX-ICH pilot trial is a phase-II study aimed at assessing the feasibility and safety of a comprehensive care bundle for patients with intracerebral hemorrhage (ICH). This \"maximal medical treatment\" approach combines advanced interventions like intensive blood pressure control, rapid anticoagulation reversal, and tranexamic acid administration to potentially improve outcomes. The primary objective is to evaluate recruitment feasibility over 12 months, while secondary objectives include protocol adherence, safety monitoring, and the exploration of clinical outcomes. The study focuses on the critical first 72 hours of care to determine if this approach can be effectively implemented in clinical practice.",[82],"Intra Cerebral Hemorrhage","2026-06-30",{"date":85,"type":86},"2026-07-02","ACTUAL",{"date":88,"type":86},"2025-08-07",{"date":90,"type":76},"2028-11-30",{"name":5,"class":6},1]