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.
Acute anterior circulation ischaemic stroke planned for endovascular thrombectomy
Age ≥18 years
Pre-stroke modified Rankin Scale score >2
Core body temperature <35°C at admission
Uncontrolled hypertension (≥185/110 mmHg despite treatment in IVT-eligible patients)
Known contraindications to hypothermia (e.g., haemodynamic instability, symptomatic bradyarrhythmia, cryoglobulinaemia, sickle cell disease, cold agglutinins)
Auckland City Hospital
Lead sponsor
Neurological Foundation of New Zealand
Collaborator
Health New Zealand
Collaborator