Safety Trial of Low-Intensity Monitoring After Thrombolysis: Optimal Post Tpa-Iv Monitoring in Ischemic STroke (OPTIMIST)

Background and Purpose: At present, stroke patients receiving intravenous thrombolysis (IVT) undergo monitoring of their neurological status and vital signs every 15 minutes for the first 2 hours, every 30 minutes for the next 6 hours, and every hour thereafter up to 24 hours post-IVT. The present study sought to prospectively evaluate whether post-IVT stroke patients with low risk for complications may safely be cared for utilizing a novel low-intensity monitoring protocol. Methods: In this pragmatic, prospective, single-center, open-label, single-arm safety study, we enrolled 35 post-IVT stroke patients. Adult patients were eligible if their NIH Stroke Scale (NIHSS) was less than 10 at the time of presentation, and if they had no critical care needs by the end of the IVT infusion. Patients underwent a low-intensity monitoring protocol during the first 24 hours after IVT. The primary outcome was need for a critical care intervention in the first 24 hours after IVT. Results: The median age was 54 years (range: 32-79), and the median pre-IVT NIHSS was 3 (interquartile range [IQR]: 1-6). None of the 35 patients required transfer to the intensive care unit or a critical care intervention in the first 24 hours after IVT. The median NIHSS at 24 hours after IVT was 1 (IQR: 0-3). Four (11.4%) patients were stroke mimics, and the vast majority was discharged to home (82.9%). At 90 days, the median NIHSS was 0 (IQR: 0-1), and the median modified Rankin Scale was 0 (range: 0-6). Conclusion: Post-IVT stroke patients may be safely monitored in the setting of a low-intensity protocol.