[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384203":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":104,"collaborators":26,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":26,"enrollmentInfo":116,"targetDuration":26,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Milrinone","EXPERIMENTAL","\"milrinone\" group benefiting from an identical treatment to the standard care group and in addition, administration of milrinone (0.75 μg \u002F kg \u002F min, intravenous) from Day 4 to Day 14. In case of suspicion of vasospasm and after ineffective effect of medical measures (euvolemia and increase in mean arterial pressure), an endovascular treatment will be possible. The occurrence of vasospasm will be monitored closely with clinical examination and cerebral tissue oxygen pressure (PtiO2). From D4 to D14, general and biological data, clinical examination will be collected daily. Intensive care unit complications (neurologic, pulmonary, cardiac and septic complications) will be collected. At 1 month, the volume of DCI lesions will be measured on CT scan. Neurologic prognosis, quality of life and mortality will be studied at 1 month, 3 month, 6 month and 1 year. Adverse events will be monitored closely.",[13],"Drug: Milrinone Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","PLACEBO_COMPARATOR","The standard care group will follow the recommended management of SAHa and will receive a placebo (intravenous glucose 5%) from Day 4 to Day 14. In case of suspicion of vasospasm and after ineffective effect of medical measures (euvolemia and increase in mean arterial pressure), an endovascular treatment will be possible. The occurrence of vasospasm will be monitored closely with clinical examination and cerebral tissue oxygen pressure (PtiO2). From D4 to D14, general and biological data, clinical examination will be collected daily. Intensive care unit complications (neurologic, pulmonary, cardiac and septic complications) will be collected. At 1 month, the volume of DCI lesions will be measured on CT scan. Neurologic prognosis, quality of life and mortality will be studied at 1 month, 3 month, 6 month and 1 year. Adverse events will be monitored closely.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Milrinone Injection","administration of milrinone (0.75 μg \u002F kg \u002F min, intravenous) from Day 4 to Day 14",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","administration of placebo (intravenous glucose 5%) from Day 4 to Day 14",[15],[32],{"name":33,"affiliation":5,"role":34},"Thomas Geeraerts, MD PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","056-177-2100","33","geeraerts.t@chu-toulouse.fr",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Nadera AINAOUI","056-177-2498","nadera.ainaoui@inserm.fr",[46,58,66,78,91],{"facility":47,"status":48,"city":49,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":26},"University Hospital Bordeaux","ACTIVE_NOT_RECRUITING","Bordeaux","France","FR",{"type":53,"coordinates":54},"Point",[55,56],-0.58046,44.84124,{"lat":56,"lon":55},{"facility":59,"status":48,"city":60,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":61,"geoPoint":65,"contacts":26},"CHUGA","Grenoble",{"type":53,"coordinates":62},[63,64],5.71479,45.17869,{"lat":64,"lon":63},{"facility":67,"status":68,"city":69,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University Hospital of La Réunion","RECRUITING","La Réunion",{"type":53,"coordinates":71},[72,73],0.11776,44.29707,{"lat":73,"lon":72},[76],{"name":77,"role":37,"phone":26,"phoneExt":26,"email":26},"Romain ASMOLOV, MD",{"facility":79,"status":68,"city":80,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"HCL","Lyon",{"type":53,"coordinates":82},[83,84],4.84789,45.74906,{"lat":84,"lon":83},[87,89],{"name":88,"role":37,"phone":26,"phoneExt":26,"email":26},"Baptiste BALANCA, MD",{"name":90,"role":37,"phone":26,"phoneExt":26,"email":26},"Baptiste BALANCA",{"facility":92,"status":68,"city":93,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University Hospital of Toulouse","Toulouse",{"type":53,"coordinates":95},[96,97],1.44367,43.60426,{"lat":97,"lon":96},[100,102],{"name":101,"role":37,"phone":26,"phoneExt":26,"email":26},"GEERAERTS Thomas, MD",{"name":103,"role":37,"phone":26,"phoneExt":26,"email":26},"Thomas GEERAERTS, MD",{"type":105,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100384203","phase-2-cerebral-hemodynamic-optimization-by-milrinone-to-prevent-delayed-cerebral-ischemia-100384203",false,"NCT04282629","Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia","Efficacy of 10 Days Intravenous Milrinone Treatment to Optimize Cerebral Hemodynamic and Prevent Delayed Cerebral Ischemia (DCI) in Patients with Severe Subarachnoid Hemorrhage Due to Intracranial Aneurysm Rupture","OPTIMIL","Inclusion Criteria:\n\n* patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma (Glasgow coma score of 8 or less) or need for sedation at D3\n* absence of pre-existing neurological handicap (mRS 0-2)\n* major patient (≥ 18 years)\n* affiliation to social security or benefiting through a third person\n* free patient, without tutorship or curatorship or under judicial protection\n* obtaining a signed informed consent by a relative (or the person of trust) after clear and fair information about the study.\n\nExclusion Criteria:\n\n* patients with non-severe SAHa (WFNS I, II and III)\n* Occurrence of a major complication (haemorrhagic or ischaemic) documented during the procedure of securing the aneurysm and endangering the short-term vital prognosis\n* heart failure requiring inotropic administration at the time of randomization\n* ICHT at the time of randomisation (ICP\\> 25 mmHg for at least 20 min)\n* known severe obstructive heart diseases\n* flutter patient or atrial fibrillation\n* hypotension and \u002F or severe hypovolemia with hemodynamic instability\n* septic shock\n* acute \u002F chronic renal insufficiency (Cl \\\u003C50ml \u002F min)\n* major hydroelectrolytic disorders (hypokalemia \\\u003C3 mmol \u002F L)\n* known hypersensitivity to milrinone or any of the excipients\n* early limitation of life-sustaining care\n* pregnancy, breastfeeding\n* permanent contraindications to MRI\n* participation in another clinical interventional study","ALL","18 Years",{"count":117,"type":118},234,"ESTIMATED","INTERVENTIONAL",[121],"PHASE2","The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and \u002F or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.",[124],"Aneurysmal Subarachnoid Hemorrhage",[9,126,127],"Vasospasm","Delayed Cerebral Ischemia","2024-09-23",{"date":130,"type":131},"2024-09-25","ACTUAL",{"date":133,"type":131},"2021-07-25",{"date":135,"type":118},"2025-07",{"name":5,"class":6},5]