Randomized, open label, parallel control, single-center
Mild hypothermia induced by internal () or external cooling () immediately after surgery. Target temperature (35°C)
25 severe ischemic stroke patients (12 craniectomy + hypothermia versus 13 craniectomy). Patients in the craniectomy control group were kept normothermic (°C)
Target temperature reached within h. Does not clear report the % of patients reaching target temperature, apparently all of them
Trend towards clinical improvement for the combined treatment NIHSS ( versus , and BI ( versus , ). No significant difference were observed in mRS ( versus , ) after 6 months
1/12 hypothermic patients died versus 2/13 patients in the craniectomy group
7/18 patients were effectively cooled (39%) and tolerated up to °C versus normothermia in the control group °C (). Target temperature (33°C)
Difference in brain edema during 36–48 h () that vanished after 30 days. No significant difference in NIHSS at catheter removal, and after 7 days. No difference in NIHSS or mRS after 30 days
Mild hypothermia induced by endovascular device within 0–3 or 3–6 hours of symptoms onset. Target temperature (33°C)
58 patients with acute stroke symptoms (NIHSS 7≥) 28 hypothermia versus 30 normothermic controls. Also compared the latency time from symptoms onset and the combination with thrombolytic therapy
Target temperature was reached in 20/28 patients (71.4%) in about 67 min (median time). Patients not reaching target temperature had a mean temperature of °C.
Difference in NIHSS at 24 h due to sedation with meperidine: in the hypothermic group versus in the controls (). The NIHSS was equivalent in both groups at 30 days ( versus ) and 90 days ( versus ). No difference in mRS at 90 days. Thrombolytic therapy (tPA) did not influence clinical outcome or occurrence of adverse events
6/28 patients died in the hypothermic group versus 5/30 in the control group Pneumonia occurred more frequently in hypothermic patients (7/28) than controls (2/30) ()