Statistical analysis plan for the “Does longer peripheral intravenous catheter Length optimise Antimicrobial Delivery: a randomised controlled trial to reduce interruptions to intravenous antimicrobial delivery (The LEADER Study)”

The “Does longer peripheral intravenous catheter (PIVC) Length optimise Antimicrobial Delivery: a randomised controlled trial to reduce interruptions to intravenous antimicrobial delivery (The LEADER Study)”, is a randomised controlled trial (RCT). This RCT aims to assess if long peripheral intravenous catheters (PIVCs) (4.5-6.4 cm) when compared with short-PIVCs (<4 cm) optimise antimicrobial delivery by reducing PIVC failure rates. The purpose for this document is to minimise bias and ensure transparency and internal validity for the findings of the trial, by defining and making publicly available the analysis approach prior to reviewing or analysing trial data. The statistical analysis plan (SAP) will inform analysis and reporting of the main effectiveness findings of the trial. It provides a detailed description of the primary and secondary trial outcomes and the methods for statistical comparison. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial The trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621001199808) ### Clinical Protocols . ### Funding Statement This study was funded by the Royal Brisbane and Women Hospital and Royal Brisbane Hospital Foundation, and Cardinal Health Infection Control Scholarship 2021 through competitive granting schemes.The funders have had no input into study design or conduct, data acquisition or analysis, or manuscript preparation. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. * ### List of abbreviation BSI : blood stream infection CI : confidence interval CVAD : central venous access devices ID : identification number IQR : interquartile range IV : intravenous PIVC : peripheral intravenous catheter RCT : randomised controlled trial research nurse ReN REDCap RR : research electronic data capture risk ratio SD SAP US : standard deviation statistical analysis plan ultrasound