ITACS: IV iron for Treatment of Anaemia before Cardiac Surgery

Outcomes

The ITACS trial investigated whether a single dose of intravenous (IV) iron given before elective cardiac surgery improves recovery in patients with preoperative anaemia. The international, double-blind, placebo-controlled randomised trial enrolled 955 adults across 33 hospitals in 10 countries between 15 July 2016 and 15 December 2023.

IV iron increased preoperative haemoglobin concentrations and partially corrected anaemia before surgery. Patients receiving IV iron had a median of 81.1 days alive and at home within 90 days of surgery, compared with 80.0 days in the placebo group, representing an adjusted median difference of 1.0 day. Exploratory analyses suggested that the benefit was greater among patients with poorer postoperative recovery profiles.

IV iron also significantly reduced red cell transfusion requirements. During the hospital stay, 61.1 per cent of patients in the IV iron group received a red cell transfusion compared with 68.2 per in the placebo group, and the investigators estimated that IV iron saved approximately 44 units of blood products for every 100 patients treated. The benefits were similar in patients with and without demonstrable iron deficiency. There were no significant differences in major complications or hospital length of stay. Adverse events were generally similar between groups, apart from an increased risk of hypophosphataemia with IV iron.

Overall, the findings support preoperative intravenous iron as an effective component of patient blood management for patients with anaemia undergoing elective cardiac surgery.

Media release

Check out our media release, Iron infusion before heart surgery helps patients recover faster.

Main publication

Myles PS, Klein AA, Smith JA, Wallace S, Forbes A, Zavarsek S, et al. Intravenous iron to treat anaemia before cardiac surgery (ITACS): international, double blind, placebo controlled randomised trial. BMJ. 2026;394:e100407. doi:10.1136/bmj-2026-100407.

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Summary

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.

Funding

The Australian National Health and Medical Research Council.

Trial registration

ClinicalTrials.gov Identifier: NCT02632760

Participating hospitals

Contact

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