Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy (COOLHEAD-2b)

Starting soon · Not applicable

Conditions studied: Stroke, Acute Ischemic Stroke, Brain Ischemia, Ischaemic Stroke, Thrombectomy, Endovascular Procedures, Reperfusion Injury, Cooling, Large Vessel Occlusion

In brief

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.

Key facts

Study ID

NCT07526649

Run by

Auckland City Hospital

People needed

182

Starts

2026-04-10

Expected to finish

2029-06-30

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute anterior circulation ischaemic stroke planned for endovascular thrombectomy
• Age ≥18 years

You may not qualify if…

• 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)
• Vasospastic disorders (e.g., Raynaud's phenomenon)
• Skin lesions preventing secure application of the cooling cap
• Inability to participate in 90-day follow-up

Where it is running

• Health New Zealand - Auckland — Grafton, Auckland, New Zealand

Full record on ClinicalTrials.gov

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