Decreased disability with early intensive care bundle for patients presenting with acute hemorrhagic stroke

Reference

Ma L, Hu X, Song L, et al, for the INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (NTERACT3): an international, stepped wedge cluster randomized controlled trial. Lancet 2023:402(10395):27-40.

Synopsis

These investigators enrolled 121 hospital sites in 10 mostly low-income and middle-income countries to implement a care bundle protocol for patients presenting within 6 hours of the onset of acute cerebral hemorrhagic stroke. The selected hospitals did not already have consistent management protocols for these patients. The care bundle consisted of intensive blood pressure lowering (< 140 mmHg), strict glucose control (110-140 mg/dL without diabetes; 140-180 mg/dL with diabetes), treatment of fever (< 37.5 degrees Celsius), and rapid reversal of warfarin-related anticoagulation (international normalized ratio < 1.5) within 1 hour of treatment. Treatment goals continued for 7 days or until discharge or death. Hospitals were randomized to 3 different sequences that dictated the order in which they would switch from usual care to the intervention care bundle. Overall, 7036 patients were enrolled in the study with 3221 allocated to the care bundle and 3815 allocated to usual care. Baseline characteristics were similar in the 2 groups. For the primary end point of functional recovery at 6 months, measured by the modified Rankin scale, patients who received the care bundle were less likely to have a poor outcome (odds ratio 0.86; 95% CI 0.76 - 0.97; P = .015). Additionally, patients in the care bundle group had fewer serious adverse events (16.0% vs 20.1%; P = .0098). Secondary outcomes including death at 6 months and hospital discharge by day 7 also favored the care bundle group, but these results were no longer significant in adjusted analyses.