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Testing Cooling Added to Clot Removal for Stroke Patients

Tests cooling the body alongside clot removal in adults with acute ischemic stroke.

Plain-language title generated from the registry record
Registry title: Role of Hypothermia in Endovascular Stroke Thrombectomy

Key facts

Where
Xiangtan, ChinaSee the site

Where in China

  • Xiangtan Central HospitalXiangtan, ChinaTaking people

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Trial details

Who runs it
Xinqiao Hospital of Chongqing
Trial code
NCT06109376
Record updated
29 October 2026
Original description
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.Read full original descriptionShow less

Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial

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.

Inclusion: Aged ≥ 18 years or more; acute ischemic stroke within 24 hours from onset to randomization; NIHSS ≥6 points before randomization; Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA; Baseline ASPECTS score ≥ 3 and ≤10, or cerebral infarction core volume < 100ml; The patient decides to undergo endovascular therapy; The patient or patient's representative signs a written informed consent form.

Exclusion: Previous bleeding disorders, severe heart (especially congestive heart failure), liver or kidney disease, or sepsis; CT or MR evidence of hemorrhage; Allergy to radiographic contrast agents, or nitinol devices; Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; Any terminal illness with life expectancy less than 6 months; Pre-randomization rectal temperature ≥ 38℃ or axillary/tympanic temperature ≥ 37.5℃; Currently pregnant or lactating (women patients); Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation); Brain tumors with mass effect (except meningiomas) that are radiographically pleasant; Intracranial aneurysm, arteriovenous malformation; Participating in other clinical trials.

ClinicalTrials.gov NCT06109376