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

Summary

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.

Conditions

• Thrombectomy
• Endovascular Procedures
• Reperfusion Injury
• Cooling
• Large Vessel Occlusion
• Stroke
• Acute Ischemic Stroke
• Brain Ischemia
• Ischaemic Stroke

Interventions

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.

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.

Sponsors & Collaborators

• Neurological Foundation of New Zealand

  collaborator UNKNOWN

• Health New Zealand

  collaborator UNKNOWN

• Auckland City Hospital

  lead OTHER_GOV

Principal Investigators

• William Diprose, MBChB · University of Auckland, New Zealand

• Alan Barber, PhD · University of Auckland, New Zealand

• Doug Campbell, MBChB · Auckland City Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-10

Primary Completion

2028-12-31

Completion

2029-06-30

Countries

• New Zealand

Study Locations