Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke

Completed

Phase 1 Results

Results

In total 59 patients were enrolled. One patient was enrolled but not treated. The mean±SE age was 65.5±12.1 years and the NIHSS was 14.0±5.0. Thirty-two (55%) patients were male. Baseline demographics and risk factors did not differ between groups. All 44 patients enrolled within 3 hours and four of 14 patients enrolled between 3-6 hours received t-PA. Overall, 28 patients were randomized to hypothermia and 30 to normothermia. In 2 patients cooling could not be achieved due to technical failure. Mean time from stroke onset to target temperature was over 6 hours. At 3 months 18% of patients treated with hypothermia had a mRS of 0 or 1, versus 24% in the control group (NS). Symptomatic intracranial hemorrhage occurred in 4 patients, all were treated with t-PA less than 3 hours (1 received hypothermia). Six patients in the hypothermia and five in the normothermia group died within 90 days (NS). Pneumonia occurred in 14 patients treated with hypothermia and in three of the control group (p=0.001). The pneumonia rate did not significantly adversely affect 3 month mRS (p=0.32). Conclusion: Endovascular hypothermia after stroke can be safely combined with intravenous thrombolysis. Pneumonia was more frequent after hypothermia, but further studies are needed to determine its effect on patient outcome and whether it can be prevented.