NCT06109376Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 22 Oct 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Diseases
- Stroke
- NCT number
- NCT06109376
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Dec 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous bleeding disorders, severe heart (especially congestive heart failure), liver or kidney disease, or sepsis;
Other illness
- CT or MR evidence of hemorrhage;
- 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;
- Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- Any terminal illness with life expectancy less than 6 months;
Other
- Pre-randomization rectal temperature ≥ 38℃ or axillary/tympanic temperature ≥ 37.5℃;
- Currently pregnant or lactating (women patients);
- Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
- Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
- Intracranial aneurysm, arteriovenous malformation;
- Participating in other clinical trials.
Who the study is looking for
- 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 ≤10, 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangtan Central Hospital Coordinator of this site? Confirm its status | Xiangtan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.