Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke (THIS)
Stroke, Ischemic
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring Therapeutic hypothermia, AIS, Neurological function prognosis
Eligibility Criteria
Inclusion Criteria: Aged 18-85 years(inclusive); Patients have clinical signs consistent with acute ischemic stroke, Patients with acute large vessel occlusion including internal carotid artery and middle cerebral artery M1 and M2 demonstrated by CTA,MRA or DSA The possibility to receive arterial thrombus removal treatment (within6 or24 hr of large vessel occlusion ); Provide the informed consent form of the patient or the patient's agent. Exclusion Criteria: Coma or altered vigilance defined as a score ≥2 on the level of consciousness 1A subscale of the NIHSS. Associated cerebral hemorrhage. There is dysfunction before the onset, mRS score >= 2 points; Accompanied by severe comorbidities (such as severe cardiopulmonary insufficiency, the expected survival period of advanced malignant tumors is less than 90 days); Multi-mode CT/MRI examination of the corresponding contrast agent use contraindications (such as contrast agent allergy, etc.); Women during pregnancy or lactation; Patients currently participating in other clinical research trials; Other conditions judged by the investigator as not suitable for inclusion in the clinical study.
Sites / Locations
- Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Normothermia arm
Therapeutic hypothermia arm
Patients randomized to normothermia will be maintained at 36-37°C during the entire study period.
Patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C