Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Collaborators: Monash University; National Health and Medical Research Council, Australia
• Treatments: Ferric Compounds; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

• Patients with anaemia (males Hb <130 g/L, females <120 g/L) undergoing elective cardiac surgery, and available to receive trial drug 1- 10 weeks prior to surgery

Exclusion Criteria:

• Pregnancy

• Known hypersensitivity to study drug (ferric carboxymaltose or equivalent) or its excipients

• Known or suspected haemoglobinopathy/thalassaemia

• Bone marrow disease

• Haemochromatosis

• Renal dialysis

• Erythropoietin or IV iron in the previous 4 weeks