Reperfusion With Hypothermia in Acute Ischemic Stroke (NCT05676957) | Clinical Trial Compass
UnknownNot Applicable
Reperfusion With Hypothermia in Acute Ischemic Stroke
30 participantsStarted 2023-03-01
Plain-language summary
The primary objective of this study is to determine the feasibility and safety of receiving intravascular hypothermia treatment for patients experiencing endovascular treatment after acute ischemic stroke(AIS) due to a large vessel occlusion.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Aged 18-80 years;
* Patients with symptoms consistent with an AIS;
* Pre-stroke mRS score 0-1;
* NIHSS score 6-30 at the time of randomization;
* Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography(MRA) proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery;
* Imaging showed massive infarction: within 24h of onset and Alberta Stroke Program Early CT Score (ASPECTS) \< 3, and large infarct core 70-100 ml (CT perfusion \[ Relative Cerebral Blood Flow (rCBF) \< 30%\]); within 24h of onset and ASPCECTS score 3-5 (based on NCCT); ASPECTS \> 5, within 6h-24h of onset,and large infarct core 70-100 ml (CTP \[rCBF \< 30%\]);
* Successful recanalization of occluded vessel (modified Thrombolysis in Cerebral Infarction (mTICI) scores 2b/3) after EVT;
* Patients and/or their families agreed to enter the trial.
Exclusion Criteria:
* CT after reperfusion showed PH2 hemorrhagic transformation;
* bilateral stroke or multiple intracranial occlusions;
* known presence of Inferior Vena Cava (IVC) filter;
* end-stage renal disease on hemodialysis;
* known hemorrhagic diathesis, coagulation factor deficiency or platelet count \< 5 × 109/L, International Normalized Ratio(INR) \> 1.7;
* known hypersensitivity to meperidine, buspirone, midazolam and other sedative and analgesic drugs;
* pregnant women;
* combined malignant tumors, sepsis, hypothyroidism;
* unstable vital signs/dying state, requiring vasoactive dr…
What they're measuring
1
Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
Timeframe: 2 hour after thrombectomy
2
final infarct volume（FIV）
Timeframe: three to seven days after endovascular therapy