HYPoxic Enhancement Before Major Surgery (HYPE): A pilot randomised controlled trial of preoperative Roxadustat vs placebo in patients undergoing major surgery - Statistical Analysis Plan

Abstract

This is a phase 2, single-centre, double-blind, placebo-controlled randomized trial to evaluate the safety and potential eZicacy of preoperative roxadustat in patients undergoing elective major noncardiac surgery. Patients take three preoperative doses of roxadustat 100mg or placebo with dose 1 four days before surgery, dose 2 two days before surgery and dose 3 on the morning of surgery.