临床试验/NCT06335641

NCT06335641进行中（未招募）不适用

Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy

University of Calgary3 个研究点分布在 2 个国家目标入组 40 人开始时间: 2024年7月28日最近更新: 2024年12月30日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: University of Calgary
入组人数: 40
试验地点: 3
主要终点: Adherence to the intervention

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.

排除标准

•Admission core body temperature <35°C.
•Known contraindications to hypothermia, including hemodynamically unstable patients, new/symptomatic arrhythmia, hematological dyscrasias that affect thrombosis (cryoglobulinemia, sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thrombo-angiitis obliterans.
•Skin lesions not allowing secure application of the cooling cap.
•Unable to participate in follow-up at 3 months (e.g., resides outside of Alberta).

结局指标

主要结局

Adherence to the intervention

时间窗: From time of application in the emergency department until the end of the endovascular thrombectomy procedure

Adherence is defined as undergoing active conductive head cooling for ≥50% of the time from first application of the cooling device

次要结局

未报告次要终点

研究者

发起方

University of Calgary

申办方类型

Other

责任方

Principal Investigator

主要研究者

William Diprose

Clinical fellow

University of Calgary

研究点 (3)

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