Trial Summary

Design

This randomised double-blind, controlled phase 4 trial will compare the efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery.

Sample Size

1000 patients

Study Duration

4 years

Primary Endpoint

Days alive and out of hospital (DAOH) from surgery to 30 days following operation. This endpoint therefore encompasses death, hospital stay, need for ongoing rehabilitation, and re-admission. It reflects personal, social and economic benefits of a good recovery after surgery.

Secondary Endpoints

Correction of anaemia (∆Hb) from treatment to day of surgery, units of allogeneic blood transfused, postoperative complications, ICU and hospital stay, disability-free survival, and 90-day mortality. Patient reported quality of life will be assessed by the MacNew Heart Disease Questionnaire and EQ-5D, and disability using WHODAS. Patients will be assessed at baseline, before operation, at discharge, Day 30, and at 3 and 6 months after surgery.

Funding

NHMRC project grant

Further Information

Contact Sophie Wallace: s.wallace@alfred.org.au