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Role of Hypothermia in Endovascular Stroke Thrombectomy
Sponsor: Xinqiao Hospital of Chongqing
Summary
Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach. In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear. The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.
Official title: Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-12-01
Completion Date
2026-12-31
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
hypothermia
In this trial, intra-arterial selective cooling infusion is used to reduce brain tissue temperature. After thrombectomy, a microcatheter was advanced to the segment between the C6 segment of the internal carotid artery and the proximal M1 segment of the middle cerebral artery. To achieve rapid targeted cooling of the ischemic cerebral region, 0-4℃ of pre-cooled normal saline was infused through the microcatheter using precision infusion pumps. The brain temperature is monitored continuously at the sigmoid sinus as a surrogate marker. Participants are assigned to one of four target cooling gradients (0.3 °C, 0.4 °C, 0.6 °C, or 1.0 °C) relative to their baseline sigmoid sinus temperature.
thrombectomy
Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.
Locations (2)
Xiangtan Central Hospital
Xiangtan, Hunan, China
Xiangtan Central Hospital
Xiangtan, Hunan, China