Role of Hypothermia in Endovascular Stroke Thrombectomy

NCT06109376 | Not Yet Recruiting DMC

• 1 other identifier: COOLING
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  90 days post-randomization

Secondary Outcomes (15)

• Excellent outcome

  90 days post-randomization

• Functional independence

  90 days post-randomization

• Moderate outcome

  90 days post-randomization

• Early neurological improvement

  72 hours post-randomization

• EQ-5D-5L scale score

  90 days post-randomization

Study Arms (2)

Hypothermia

EXPERIMENTAL

Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.

Procedure: hypothermia; Procedure: thrombectomy

Control

ACTIVE COMPARATOR

Patients in Control group received endovascular thrombectomy alone.

Procedure: thrombectomy

Interventions

hypothermia PROCEDURE

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

Hypothermia

thrombectomy PROCEDURE

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

Control; Hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤8, 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.

You may not qualify if:

• CT or MR evidence of hemorrhage;
• Currently pregnant or lactating (women patients);
• 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;
• Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
• Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
• Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
• Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
• Intracranial aneurysm, arteriovenous malformation;
• Any terminal illness with life expectancy less than 6 months;
• Participating in other clinical trials.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• Xiangtan Central Hospital: collaborator

MeSH Terms

Conditions

Ischemic Stroke; Hypothermia

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Guangxiong Yuan, M.S.

CONTACT

18973223018; yuanguangxiong74@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 31, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years after the trial results are revealed.
• Access Criteria: after approval of a proposal from principal investigator