Nishita Singh, Jeffrey Saver, Aravind Ganesh, Jonathan Coutinho, Bob Roozenbeek, Salome Bosshart, Alexander Stebner, Andrew Demchuk, Michael D Hill, Philip M Bath, Cheryl Carcel, Craig S Anderson, Mayank Goyal, H B Van Der Worp
Prehospital stroke trials enable assessments of ultraearly administration of treatments and management strategies, but face unique challenges in their design, conduct, and analysis. We outline important considerations and recommendations for planning prehospital stroke trials, focusing on patient identification, consent models, randomization strategies, end point selection, and statistical frameworks. As this field evolves, multidisciplinary collaboration, pragmatic study design, and scalable technology integration are critical to ensuring scientific rigor and equitable access. This framework is intended to inform and support future investigators in designing effective, ethically sound, and operationally feasible prehospital stroke trials in conventional emergency medical services settings.