hypothermia
ProcedureIn this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.
NCT Number: NCT06109376
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.
Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.
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
Time frame: 90 days post-randomization
Score of 0-1 on the modified Rankin scale
Time frame: 90 days post-randomization
Score of 0-2 on the modified Rankin scale
Time frame: 90 days post-randomization
Score of 0-3 on the modified Rankin scale
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
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.
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.
Time frame: 48 hours post-randomization
Time frame: 48 hours post-randomization
Time frame: 48 hours post-randomization
using Heidelberg criteria to assess SICH
Time frame: 48 hours post-randomization
Time frame: 90 days post-randomization
Time frame: 24-hour post-randomization
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.
Time frame: 90 days post-randomization
vasospasm, arterial rupture, arterial dissection, vascular puncture point complications, etc.
Time frame: 90 days post-randomization
Contact information is provided by the study sponsor or research team.
Xinqiao Hospital of Chongqing
Other
Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial
Acronym: COOLING
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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.
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