Clinical trial NCT06109376: Role of Hypothermia in Endovascular Stroke Thrombectomy
Official title: Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Acute Ischemic
Keywords: endovascular thrombectomy
hypothermia
large vessel occlusion
randomized controlled trial
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: Xiangtan Central Hospital
First posted: 2023-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Modified Rankin scale score (mRS)
timeFrame: 90 days post-randomization
Secondary outcomes:
measure: Excellent outcome
timeFrame: 90 days post-randomization
measure: Functional independence
timeFrame: 90 days post-randomization
measure: Moderate outcome
timeFrame: 90 days post-randomization
measure: Early neurological improvement
timeFrame: 72 hours post-randomization
measure: EQ-5D-5L scale score
timeFrame: 90 days post-randomization
measure: Successful reperfusion at final angiogram
timeFrame: At the end of angiography or procedure
measure: Difference between baseline and within 48h after procedure of infarction core volume (ml)
timeFrame: 48 hours post-randomization
measure: Reperfusion on follow-up CT or MR angiography
timeFrame: 48 hours post-randomization
measure: Incidence of symptomatic intracranial hemorrhage (SICH)
timeFrame: 48 hours post-randomization
measure: incidence of any intracranial hemorrhage (any ICH)
timeFrame: 48 hours post-randomization
measure: 90-day mortality
timeFrame: 90 days post-randomization
measure: Difference of hematocrit between baseline and 24-hour post-randomization
timeFrame: 24-hour post-randomization
measure: Non-hemorrhagic serious adverse event rate
timeFrame: 90 days post-randomization
measure: Complications related to operation and device
timeFrame: 90 days post-randomization
measure: Other serious adverse events
timeFrame: 90 days post-randomization
Other outcomes:
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