ITACS: IV iron for Treatment of Anaemia before Cardiac Surgery

The trial completed recruitment in December 2023. The trial recruited 955 patients in New Zealand, Australia, South Africa, Singapore, Hong Kong, Malaysia, Abu Dhabi, Canada, Germany and the United Kingdom. 

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
Four years.

Primary Endpoint
Days alive and at home up to 90 days after surgery (DAH90). This endpoint therefore encompasses death, hospital stay, need for ongoing rehabilitation, and re-admission(s). 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, red cell transfusions, postoperative complications, ICU and hospital stay, disability-free survival, days alive and at home 30 days after surgery (DAH30) and 90-day mortality. Patient reported quality of life will be assessed by the MacNew Heart Disease Questionnaire and EQ5D, and disability using WHODAS. Patients will be assessed at baseline, before operation, at discharge, Day 30, and at three and six months after surgery.

The Australian National Health and Medical Research Council.

ClinicalTrials.gov Identifier: NCT02632760

$A1100

For further information about this study, please contact the ITACS Project Manager, Sophie Wallace by email.