Role of Hypothermia in Endovascular Stroke Thrombectomy
ConditionStroke, Acute Ischemic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinqiao Hospital of Chongqing
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- hypothermia
- thrombectomy
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Xinqiao Hospital of Chongqing
Lead sponsor
Xiangtan Central Hospital
Collaborator
Source ClinicalTrials.gov