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)
Parallel
Non-invasive convective head cooling
DeviceNon-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.
Standard of Care (SOC)
Other interventionGuideline-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.
Final Infarct Volume
Final infarct volume (mL), defined as the manually segmented volume of infarcted brain tissue on 24-hour follow-up CT or MRI brain imaging. Segmentation will be performed by a blinded imaging core laboratory using de-identified imaging files.
Infarct growth
Infarct growth, defined as the difference between the final infarct volume on 24-hour follow-up imaging and the baseline infarct core volume estimated using automated CT perfusion software (relative cerebral blood flow \<30%).
Penumbral salvage index
Penumbral salvage index, defined as the proportion of baseline hypoperfused or penumbral brain tissue not progressing to infarction, calculated using baseline CT perfusion imaging and final infarct volume on 24-hour follow-up imaging.
Early neurological improvement
Early neurological improvement, defined as the percentage change in the National Institutes of Health Stroke Scale (NIHSS), a neurological deficit scale ranging from 0 to 42 where higher scores indicate worse neurological impairment, from baseline to 24 hours
Modified Rankin Scale (mRS) score
Degree of disability or dependence in daily activities measured using the modified Rankin Scale (mRS), an ordinal scale ranging from 0 (no symptoms) to 6 (death), where higher scores indicate greater disability. Assessment is performed by a trained, blinded study team member using the Rankin Focused Assessment.
All cause mortality
Death from any cause.
Number of Participants with Symptomatic Intracranial Haemorrhage
Symptomatic intracranial haemorrhage defined according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria as a parenchymal haemorrhage type 2 associated with neurological deterioration (increase in NIHSS score ≥4 points) or death.
Number of Participants with New Arrhythmia and Haemodynamic Compromise
Occurrence of a new cardiac arrhythmia associated with haemodynamic instability requiring clinical intervention.
Number of Participants with Uncontrolled Hypertension During Head Cooling
Blood pressure \>185/110 mmHg or an absolute increase in systolic blood pressure ≥30 mmHg from baseline on two consecutive measurements despite standard pharmacological treatment.
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Auckland City Hospital
Lead sponsor
Neurological Foundation of New Zealand
Collaborator
Health New Zealand
Collaborator
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