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

Auckland City Hospital

Status: Not yet enrolling

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

Treatments: Other: Standard of Care (SOC); Device: Non-invasive convective head cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT07526649

COOLHEAD-2B

A+10418 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Despite advances in reperfusion therapy, a substantial proportion of patients undergoing EVT for acute ischaemic stroke experience poor functional outcomes, particularly those with delayed reperfusion due to interhospital transfer. Therapeutic hypothermia is a potent neuroprotective intervention in preclinical stroke models but has not been successfully translated into clinical practice due to delayed initiation and systemic complications.

Convective head cooling is a non-invasive, portable method capable of selectively reducing brain temperature while minimizing systemic hypothermia. Phase 1 and feasibility studies (COOLHEAD-1 and COOLHEAD-2a) demonstrated that this approach is safe, well-tolerated, and feasible in patients undergoing EVT.

COOLHEAD-2b will test whether convective head cooling reduces infarct volume and improves clinical outcomes when applied early and continued throughout the EVT workflow, including interhospital transfer. Participants will be randomised 1:1 to head cooling plus standard care or standard care alone. Outcome assessors and imaging core laboratory staff will be blinded to treatment allocation.

All outcome measures are derived from prospectively collected clinical, imaging, and procedural data. Imaging outcomes are assessed by a blinded core laboratory using standardized methods. Functional outcome assessments are performed by trained assessors blinded to treatment allocation. Safety outcomes are actively monitored throughout the peri-procedural and post-procedural periods.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

182 participants in 2 patient groups

Non-invasive Convective Head Cooling + Standard of Care

Experimental group

Description:

Participants receive non-invasive convective head cooling in addition to standard clinical care for acute anterior circulation ischaemic stroke undergoing endovascular thrombectomy. Head cooling is initiated as early as possible following randomisation and continued throughout interhospital transfer (if applicable), endovascular thrombectomy, and for one hour after reperfusion.

Treatment:

Device: Non-invasive convective head cooling

Standard of Care (SOC) Alone

Active Comparator group

Description:

Participants receive standard clinical care for acute anterior circulation ischaemic stroke undergoing endovascular thrombectomy, without head cooling.

Treatment:

Other: Standard of Care (SOC)