[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633435":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":41,"locations":47,"responsibleParty":71,"collaborators":73,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":26,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":106,"overallStatus":113,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Auckland City Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-invasive Convective Head Cooling + Standard of Care","EXPERIMENTAL","Participants receive non-invasive convective head cooling in addition to standard clinical care for acute anterior circulation ischaemic stroke undergoing endovascular thrombectomy. Head cooling is initiated as early as possible following randomisation and continued throughout interhospital transfer (if applicable), endovascular thrombectomy, and for one hour after reperfusion.",[13],"Device: Non-invasive convective head cooling",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care (SOC) Alone","ACTIVE_COMPARATOR","Participants receive standard clinical care for acute anterior circulation ischaemic stroke undergoing endovascular thrombectomy, without head cooling.",[19],"Other: Standard of Care (SOC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Non-invasive convective head cooling","Non-invasive convective head cooling delivered using a cooling cap system that circulates chilled fluid around the scalp and neck. Cooling is commenced in the emergency department following randomisation, with a target coolant temperature of -5 °C (adjustable for comfort). Cooling is continued during interhospital transfer (if applicable), during the endovascular thrombectomy procedure, and for one hour following reperfusion. Systemic rewarming measures may be used to maintain core body temperature above 35 °C if required.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Standard of Care (SOC)","Guideline-based management of acute ischaemic stroke, including endovascular thrombectomy, with supportive medical care as determined by the treating clinical team. No head cooling device is applied.",[15],[33,37,39],{"name":34,"affiliation":35,"role":36},"William Diprose, MBChB","University of Auckland, New Zealand","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":36},"Alan Barber, PhD",{"name":40,"affiliation":5,"role":36},"Doug Campbell, MBChB",[42],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Davina J McAllister, DipNursing","CONTACT","+64274891940","davina.mcallister@tewhatuora.govt.nz",[48],{"facility":49,"status":26,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Health New Zealand - Auckland","Grafton","Auckland","1023","New Zealand","NZ",{"type":56,"coordinates":57},"Point",[58,59],174.76566,-36.86029,{"lat":59,"lon":58},[62,64,67,68],{"name":43,"role":44,"phone":63,"phoneExt":26,"email":46},"0274891940",{"name":65,"role":44,"phone":26,"phoneExt":26,"email":66},"Jessica Wiles, BHSc - Nursing","jessica.wiles@TeWhatuOra.govt.nz",{"name":40,"role":36,"phone":26,"phoneExt":26,"email":26},{"name":69,"role":70,"phone":26,"phoneExt":26,"email":26},"Brandon Lucke-Wold, PhD","SUB_INVESTIGATOR",{"type":72,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[74,77],{"name":75,"class":76},"Neurological Foundation of New Zealand","UNKNOWN",{"name":78,"class":76},"Health New Zealand","100633435","head-cooling-in-ischaemic-stroke-patients-undergoing-endovascular-thrombectomy-coolhead-2b-100633435",false,"NCT07526649","Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy (COOLHEAD-2b)","Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy: A Phase 2 Randomised Controlled Trial (COOLHEAD-2b)","COOLHEAD-2B","Inclusion Criteria:\n\n* Acute anterior circulation ischaemic stroke planned for endovascular thrombectomy\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Pre-stroke modified Rankin Scale score \\>2\n* Core body temperature \\\u003C35°C at admission\n* Uncontrolled hypertension (≥185\u002F110 mmHg despite treatment in IVT-eligible patients)\n* Known contraindications to hypothermia (e.g., haemodynamic instability, symptomatic bradyarrhythmia, cryoglobulinaemia, sickle cell disease, cold agglutinins)\n* Vasospastic disorders (e.g., Raynaud's phenomenon)\n* Skin lesions preventing secure application of the cooling cap\n* Inability to participate in 90-day follow-up","ALL","18 Years",{"count":90,"type":91},182,"ESTIMATED","INTERVENTIONAL",[94],"NA","COOLHEAD-2b is a multicentre, phase 2, prospective, randomised, controlled, open-label, blinded-endpoint trial evaluating the safety and efficacy of non-invasive convective head cooling as an adjunct to endovascular thrombectomy (EVT) in patients with acute anterior circulation ischaemic stroke. Head cooling is initiated as early as possible, including during inter-hospital transfer, and continued until one hour after reperfusion. The primary efficacy endpoint is final infarct volume at 24 hours.",[97,98,99,100,101,102,103,104,105],"Stroke","Acute Ischemic Stroke","Brain Ischemia","Ischaemic Stroke","Thrombectomy","Endovascular Procedures","Reperfusion Injury","Cooling","Large Vessel Occlusion",[107,108,109,110,111,112],"Head cooling","Selective brain cooling","Endovascular thrombectomy","Therapeutic hypothermia","Penumbra","Neuroprotection","NOT_YET_RECRUITING","2026-04-09",{"date":116,"type":117},"2026-04-13","ACTUAL",{"date":119,"type":91},"2026-04-10",{"date":121,"type":91},"2029-06-30",{"name":5,"class":6},1]