Role of Hypothermia in Endovascular Stroke Thrombectomy

N/ANot Yet RecruitingNCT06109376

Xinqiao Hospital of Chongqing200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Stroke, Acute Ischemic

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Modified Rankin scale score (mRS)

Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death

Time frame: 90 days post-randomization

Secondary Outcomes

Excellent outcome

Score of 0-1 on the modified Rankin scale

Time frame: 90 days post-randomization

Functional independence

Score of 0-2 on the modified Rankin scale

Time frame: 90 days post-randomization

Moderate outcome

Score of 0-3 on the modified Rankin scale

Time frame: 90 days post-randomization

Early neurological improvement

Compared with baseline NIHSS, the 72h NIHSS score is reduced by 8 points or more, or the 72h NIHSS is 0\~1 point

Time frame: 72 hours post-randomization

EQ-5D-5L scale score

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Time frame: 90 days post-randomization

Successful reperfusion at final angiogram

Successful reperfusion was defined as grade 2b to 3 on the extended Thrombectomy in the Cerebral Ischemia system.

Time frame: At the end of angiography or procedure

Difference between baseline and within 48h after procedure of infarction core volume (ml)

Time frame: 48 hours post-randomization

Reperfusion on follow-up CT or MR angiography

Time frame: 48 hours post-randomization

Incidence of symptomatic intracranial hemorrhage (SICH)

using Heidelberg criteria to assess SICH

Time frame: 48 hours post-randomization

incidence of any intracranial hemorrhage (any ICH)

Time frame: 48 hours post-randomization

90-day mortality

Time frame: 90 days post-randomization

Difference of hematocrit between baseline and 24-hour post-randomization

Time frame: 24-hour post-randomization

Non-hemorrhagic serious adverse event rate

including pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc.

Time frame: 90 days post-randomization

Complications related to operation and device

vasospasm, arterial rupture, arterial dissection, vascular puncture point complications, etc.

Time frame: 90 days post-randomization

Other serious adverse events

Time frame: 90 days post-randomization

Role of Hypothermia in Endovascular Stroke Thrombectomy

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts