NCT07526649Not yet recruiting
Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy (COOLHEAD-2b)
Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy: A Phase 2 Randomised Controlled Trial (COOLHEAD-2b)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- First submitted
- 29 Mar 2026
- Start date
- 10 Apr 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Auckland City Hospital
- Diseases
- Stroke
- NCT number
- NCT07526649
What you commit to
- Study type: Interventional
- Planned participants: 182
- From 10 Apr 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Core body temperature \<35°C at admission
- Skin lesions preventing secure application of the cooling cap
- Inability to participate in 90-day follow-up
Who the study is looking for
- Acute anterior circulation ischaemic stroke planned for endovascular thrombectomy
- Age ≥18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health New Zealand - Auckland Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.