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

Официальное название

Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy: A Phase 2 Randomised Controlled Trial (COOLHEAD-2b)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 temperat
• Другое 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.

Первичные конечные точки

• Final Infarct Volume [Срок оценки: 24 hours after endovascular thrombectomy]

Вторичные конечные точки (7)

• Infarct growth [Срок оценки: Baseline imaging to 24 hours after endovascular thrombectomy]
• Penumbral salvage index [Срок оценки: Baseline imaging to 24 hours after endovascular thrombectomy]
• Early neurological improvement [Срок оценки: Baseline to 24 hours after endovascular thrombectomy]
• Modified Rankin Scale (mRS) score [Срок оценки: 90 days after endovascular thrombectomy]
• Proportion of Participants with Functional Independence [Срок оценки: 90 days after endovascular thrombectomy]
• Proportion of Participants with Excellent Functional Outcome [Срок оценки: 90 Days post endovascular thrombectomy]
• Days Alive and Out of Hospital (DAOH-90) [Срок оценки: First 90 days after endovascular thrombectomy]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Новая Зеландия · 1 центр

• Health New Zealand - Auckland — Grafton

Публикации

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• Diprose WK, Wang MTM, Campbell D, Sutcliffe JA, McFetridge A, Chiou D, Lai J, Barber PA. Intravenous Propofol Versus Volatile Anesthetics For Stroke Endovascular Thrombectomy. J Neurosurg Anesthesiol. 2021 Jan;33(1):39-43. doi: 10.1097/ANA.0000000000000639. PMID 31453877
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• Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborator PMID 26898852

Идентификаторы

NCT: NCT07526649 · COOLHEAD-2B · A+10418

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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