Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06109376

Role of Hypothermia in Endovascular Stroke Thrombectomy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypothermia

Procedure

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

Thrombectomy

Procedure

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

Primary outcomes

  1. Modified Rankin scale score (mRS)

    Time frame: 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 outcomes

  1. Excellent outcome

    Time frame: 90 days post-randomization

    Score of 0-1 on the modified Rankin scale

  2. Functional independence

    Time frame: 90 days post-randomization

    Score of 0-2 on the modified Rankin scale

  3. Moderate outcome

    Time frame: 90 days post-randomization

    Score of 0-3 on the modified Rankin scale

  4. Early neurological improvement

    Time frame: 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

  5. EQ-5D-5L scale score

    Time frame: 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.

  6. Successful reperfusion at final angiogram

    Time frame: 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.

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

    Time frame: 48 hours post-randomization

  8. Reperfusion on follow-up CT or MR angiography

    Time frame: 48 hours post-randomization

  9. Incidence of symptomatic intracranial hemorrhage (SICH)

    Time frame: 48 hours post-randomization

    using Heidelberg criteria to assess SICH

  10. incidence of any intracranial hemorrhage (any ICH)

    Time frame: 48 hours post-randomization

  11. 90-day mortality

    Time frame: 90 days post-randomization

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

    Time frame: 24-hour post-randomization

  13. Non-hemorrhagic serious adverse event rate

    Time frame: 90 days post-randomization

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

  14. Complications related to operation and device

    Time frame: 90 days post-randomization

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

  15. Other serious adverse events

    Time frame: 90 days post-randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Guangxiong Yuan, M.S.

CONTACT

[email protected]

18973223018

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Collaborators

  • Xiangtan Central Hospital

Registry information

Official study title

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

Acronym: COOLING

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 31, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.