PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke—statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment

Abstract

Rationale: Aspiration, infections, and fever are common in the first days after stroke, especially in older patients. The occurrence of these complications has been associated with an increased risk of death or dependency. Aims and design: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3 × 2 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly patients with acute stroke. Discussion: This statistical analysis plan provides a technical description of the statistical methodology and unpopulated tables and figures. The paper is written prior to data lock and unblinding of treatment allocation. Trial registration: ISRCTN registry ISRCTN82217627. Registered on 22 September 2015. The trial was prospectively registered.