COOLING: Role of Hypothermia in Endovascular Stroke Thrombectomy

Sponsor

Xinqiao Hospital of Chongqing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06109376

Collaborator

Xiangtan Central Hospital (Other)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Ischemic	Procedure: hypothermia Procedure: thrombectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypothermia Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.	Procedure: hypothermia In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C. Procedure: thrombectomy Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.
Active Comparator: Control Patients in Control group received endovascular thrombectomy alone.	Procedure: thrombectomy Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.

Arm

Intervention/Treatment

Experimental: Hypothermia

Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.

Procedure: hypothermia

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

Procedure: thrombectomy

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

Active Comparator: Control

Patients in Control group received endovascular thrombectomy alone.

Procedure: thrombectomy

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

Outcome Measures

Primary Outcome Measures

Modified Rankin scale score (mRS) [90 days post-randomization]
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

Secondary Outcome Measures

Excellent outcome [90 days post-randomization]
Score of 0-1 on the modified Rankin scale
Functional independence [90 days post-randomization]
Score of 0-2 on the modified Rankin scale
Moderate outcome [90 days post-randomization]
Score of 0-3 on the modified Rankin scale
Early neurological improvement [72 hours post-randomization]
Compared with baseline NIHSS, the 72h NIHSS score is reduced by 8 points or more, or the 72h NIHSS is 0~1 point
EQ-5D-5L scale score [90 days post-randomization]
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.
Successful reperfusion at final angiogram [At the end of angiography or procedure]
Successful reperfusion was defined as grade 2b to 3 on the extended Thrombectomy in the Cerebral Ischemia system.
Difference between baseline and within 48h after procedure of infarction core volume (ml) [48 hours post-randomization]
Reperfusion on follow-up CT or MR angiography [48 hours post-randomization]
Incidence of symptomatic intracranial hemorrhage (SICH) [48 hours post-randomization]
using Heidelberg criteria to assess SICH
incidence of any intracranial hemorrhage (any ICH) [48 hours post-randomization]
90-day mortality [90 days post-randomization]
Difference of hematocrit between baseline and 24-hour post-randomization [24-hour post-randomization]
Non-hemorrhagic serious adverse event rate [90 days post-randomization]
including pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc.
Complications related to operation and device [90 days post-randomization]
vasospasm, arterial rupture, arterial dissection, vascular puncture point complications, etc.
Other serious adverse events [90 days post-randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.