Role of Hypothermia in Endovascular Stroke Thrombectomy

NCT ID: NCT06109376

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-03-31

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.

Conditions

Stroke, Acute Ischemic

Keywords

endovascular thrombectomy; hypothermia; large vessel occlusion; randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypothermia

Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.

Group Type: EXPERIMENTAL

hypothermia

Intervention Type: PROCEDURE

In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.

thrombectomy

Intervention Type: PROCEDURE

Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.

Control

Patients in Control group received endovascular thrombectomy alone.

Group Type: ACTIVE_COMPARATOR

thrombectomy

Intervention Type: PROCEDURE

Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.

Interventions

hypothermia

In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.

Intervention Type: PROCEDURE

thrombectomy

Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangtan Central Hospital

OTHER

Sponsor Role: collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Zhongming Qiu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Guangxiong Yuan, M.S.

Role: CONTACT

Phone: 18973223018

Email: yuanguangxiong74@163.com

Other Identifiers

COOLING

Identifier Type: -

Identifier Source: org_study_id