Professor Paul Myles (Monash University and Alfred Health).
The trial is now recruiting at 27 centres in New Zealand, Australia, South Africa, Singapore, Hong Kong, Malaysia, Abu Dhabi, Canada, Germany and the United Kingdom. As a result of the worldwide COVID pandemic recruitment to the ITACS trial has slowed down but many countries are now in the process of commencing recruitment. The trial has recruited 850 patients worldwide.
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.
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.
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
For further information about this study, please contact the ITACS Project Manager, Sophie Wallace by email.