1. INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial
- Author
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Lili Song, Xin Hu, Lu Ma, Xiaoying Chen, Menglu Ouyang, Laurent Billot, Qiang Li, Paula Muñoz-Venturelli, Carlos Abanto, Octavio Marques Pontes-Neto, Arauz Antonio, Mohammad Wasay, Asita de Silva, Nguyen Huy Thang, Jeyaraj Durai Pandian, Kolawole Wasiu Wahab, Chao You, Craig S. Anderson, and for the INTERACT3 investigators
- Subjects
Stepped-wedge cluster-randomized trial ,Clinical trial ,Care bundle ,management ,Intracerebral hemorrhage ,Stroke ,Medicine (General) ,R5-920 - Abstract
Abstract Background Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH. Methods INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (
- Published
- 2021
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