Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery

NCT02632760 | Completed Phase 4 DMC

• 1 other identifier: 605/15
• Study Type: interventional
• Target: 955
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anaemia

Outcome Measures

Primary Outcomes (1)

• Days alive and out of hospital.

  90 days post surgery. the number of days the patient was not in hospital or care facility during the 90 day period from surgery.

  induction of anaesthesia for cardiac surgery up to 90 days post operatively

Secondary Outcomes (9)

• Correction of anemia following administration of trial drug to day of surgery measure by hemoglobin

  from administration of trial drug up to induction of anaesthesia for cardiac surgery up to 10 weeks

• Intensive care stay

  induction of anaesthesia for cardiac surgery to 30 days post operatively

• hospital stay

  induction of anaesthesia for cardiac surgery to 30 days post operatively

• Disability-free survival

  180 days from induction of anaesthesia for cardiac surgery

• 90-day survival

  induction of anaesthesia for cardiac surgery up to 90 days post operatively

Other Outcomes (2)

• Anaphylaxis

  during administration of the trial drug (up to 1 hour)

• Infection

  induction of anaesthesia for cardiac surgery to 30 days post operatively

Study Arms (2)

ferric carboxymaltose

ACTIVE COMPARATOR

ferric carboxymaltose 1000 mg or Iron isomaltoside 1000 mg given Intravenously

Drug: Ferric carboxymaltose

Placebo

PLACEBO COMPARATOR

Placebo intravenous infusion

Drug: Placebo

Interventions

Ferric carboxymaltose DRUG

treatment for Iron deficient anaemia

Also known as: ferinject, Iron isomaltoside

ferric carboxymaltose

Placebo DRUG

placebo - no active drug

Also known as: No active drug

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead
• National Health and Medical Research Council, Australia: collaborator
• Monash University: collaborator

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3181, Australia

Location

Related Publications (1)

• Cameron MJ, Al Kharusi L, Gosselin A, Baradari PG, Chirico A, Amar-Zifkin A, Yang SS. Iron supplementation for patients undergoing cardiac surgery: a protocol for a systematic review and meta-analysis of randomized controlled trials. CMAJ Open. 2021 Jun 4;9(2):E623-E626. doi: 10.9778/cmajo.20200204. Print 2021 Apr-Jun.

  PMID: 34088733 DERIVED

Related Links

• ITACS web site

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Paul S Myles, MD

  Bayside Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 17, 2015
• Study Start: July 15, 2016
• Primary Completion: April 16, 2024
• Study Completion: November 27, 2024
• Last Updated: January 2, 2026

Record last verified: 2024-12

Locations

AU (1)