Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy: A Phase 2 Randomised Controlled Trial (COOLHEAD-2b)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Final Infarct Volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute anterior circulation ischaemic stroke planned for endovascular thrombectomy
- •Age ≥18 years
排除标准
- •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
研究组 & 干预措施
Non-invasive Convective Head Cooling + Standard of Care
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.
干预措施: Non-invasive convective head cooling (Device)
Standard of Care (SOC) Alone
Participants receive standard clinical care for acute anterior circulation ischaemic stroke undergoing endovascular thrombectomy, without head cooling.
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Final Infarct Volume
时间窗: 24 hours after endovascular thrombectomy
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.
次要结局
- Infarct growth(Baseline imaging to 24 hours after endovascular thrombectomy)
- Penumbral salvage index(Baseline imaging to 24 hours after endovascular thrombectomy)
- Early neurological improvement(Baseline to 24 hours after endovascular thrombectomy)
- Modified Rankin Scale (mRS) score(90 days after endovascular thrombectomy)
- Proportion of Participants with Functional Independence(90 days after endovascular thrombectomy)
- Proportion of Participants with Excellent Functional Outcome(90 Days post endovascular thrombectomy)
- Days Alive and Out of Hospital (DAOH-90)(First 90 days after endovascular thrombectomy)