Tests head cooling alongside clot removal in acute ischemic stroke
Tests head cooling with clot removal in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy (COOLHEAD-2b)
Key facts
- Where
- Grafton, New ZealandSee the site
Where in New Zealand
- Health New Zealand - AucklandGrafton, New ZealandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Auckland City Hospital
- Trial code
- NCT07526649
- Record updated
- 13 April 2026
- Original description
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.Read full original descriptionShow less
Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy: A Phase 2 Randomised Controlled Trial (COOLHEAD-2b)
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.
Inclusion: Acute anterior circulation ischaemic stroke planned for endovascular thrombectomy; Age ≥18 years.
Exclusion: Pre-stroke modified Rankin Scale score >2; 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); Vasospastic disorders (e.g., Raynaud's phenomenon); Core body temperature <35°C at admission; Skin lesions preventing secure application of the cooling cap; Inability to participate in 90-day follow-up.