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ScenarioYou are caring for a 68 year old man who has hypertension (intermittently controlled) with a remote gastrointestinal bleed and non-valvular atrial fibrillation (NVAF) for 3 months, and an enlarged left atrium (so cardioversion is unlikely). The patient has no history of stroke or transient ischaemic attack. His father experienced a debilitating stroke several years ago and when he learns that his atrial fibrillation places him at higher risk for a stroke, he is visibly distressed.

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The number of patients undergoing noncardiac surgery is growing worldwide. To optimally assist patients during the perioperative period, we must improve our knowledge of how to prevent major perioperative cardiovascular events around the time of noncardiac surgery. To achieve this goal there is a need for large randomized controlled trials that can provide reliable and conclusive results in this field. This narrative review describes a proposal for the design, conduct and management of large controlled trials in perioperative cardiovascular medicine.

BackgroundApproximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020.Methods and DesignThe Aqueous-PREP trial is a pragmatic, multicentre, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites.ResultsThe primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention’s National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture.ConclusionThis manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.Trial Registrationclinicaltrials.gov, NCT03385304. Registered December 28 2017, https://www.clinicaltrials.gov/ct2/show/NCT03385304?term=slobogean&draw=2&rank=3