Combination of Targeted Temperature Management and Thrombectomy After Acute Ischemic Stroke (COTTIS-2) - a Randomised Controlled Study

What this Trial Is About

Researchers are evaluating whether adding targeted cooling (hypothermia) to the standard endovascular treatment can improve outcomes for adults who have suffered an acute ischemic stroke caused by large vessel blockage. This Phase 3 randomized trial compares the use of a noninvasive transnasal cooling device (RhinoChill) combined with thrombectomy versus thrombectomy alone, aiming to see if maintaining a body temperature of 356C for 6 hours after reopening the blocked vessel leads to better recovery three months later without significant complications. Participants are randomly assigned to one of two groups: one receiving standard endovascular treatment (thrombectomy and best medical care including intravenous thrombolysis) and the other receiving the same treatment plus hypothermia. Hypothermia is started immediately after intubation by using RhinoChill to lower the body temperature to 356C, maintained for six hours after vessel reopening via surface cooling, and followed by slow rewarming at 0.26C per hour to 36.56C. The study builds on earlier pilot data showing this cooling method is feasible and safe. During the study, participants undergo assessments including imaging scans to confirm vessel occlusion and evaluate brain infarction, neurological exams, and functional outcome evaluations over a three-month period. Researchers will monitor temperature, recanalization success, infarction volume, neurological improvement, mortality, and hospital stay duration. The primary outcome measure is functional status at three months post-treatment. Participants are observed closely for safety and treatment adherence throughout the trial.

Combination of Hypothermia and Thrombectomy in Acute Stroke