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Not yet recruiting NCT06109376

Role of Hypothermia in Endovascular Stroke Thrombectomy

No phase Interventional Stroke, Acute Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hypothermia, thrombectomy.
Who it may be relevant to
Registry conditions: Stroke, Acute Ischemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Modified Rankin scale score (mRS) [Time frame: 90 days post-randomization]
Secondary outcome measures (12)
  • Excellent outcome [Time frame: 90 days post-randomization]
  • Functional independence [Time frame: 90 days post-randomization]
  • Moderate outcome [Time frame: 90 days post-randomization]
  • Early neurological improvement [Time frame: 72 hours post-randomization]
  • EQ-5D-5L scale score [Time frame: 90 days post-randomization]
  • Successful reperfusion at final angiogram [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) [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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06109376 · COOLING

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗