Role of Hypothermia in Endovascular Stroke Thrombectomy (COOLING)

Army Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Stroke, Acute Ischemic

Treatments: Procedure: hypothermia; Procedure: thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06109376

COOLING

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥ 18 years or more;
2. acute ischemic stroke within 24 hours from onset to randomization;
3. NIHSS ≥6 points before randomization;
4. Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;
5. Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume < 100ml;
6. The patient decides to undergo endovascular therapy;
7. The patient or patient's representative signs a written informed consent form.

Exclusion criteria

1. CT or MR evidence of hemorrhage;
2. Currently pregnant or lactating (women patients);
3. Allergy to radiographic contrast agents, or nitinol devices;
4. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
5. Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
6. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
7. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
8. Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
9. Intracranial aneurysm, arteriovenous malformation;
10. Any terminal illness with life expectancy less than 6 months;
11. Participating in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Hypothermia

Experimental group

Description:

Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.

Treatment:

Procedure: hypothermia

Procedure: thrombectomy

Control

Active Comparator group

Description:

Patients in Control group received endovascular thrombectomy alone.

Treatment:

Procedure: thrombectomy