Overview

Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery

Status:
Completed
Trial end date:
2021-01-02
Target enrollment:
0
Participant gender:
All
Summary
Several studies using new forms of intravenous iron showed that it is effective in treating perioperative anemia in orthopedic and digestive surgery. Effects of ferric carboxymaltose have not been assessed in the settings of cardiac surgery. This study will compare ferric carboxymaltose to placebo in a randomized trial design where ferric carboxymaltose / placebo will be administered in the postoperative period (Day 1) after cardiac surgery. A total sample size of 200 patients (100 per group) will be needed. The FCAACS trial will assess the impact of administering intravenous iron (Ferric carboxymaltose) after cardiac surgery with cardiopulmonary bypass (CPB) on the: - incidence of postoperative anemia - incidence of postoperative transfusion - incidence of complications related to intravenous iron All the surgeries will be performed by the same surgical team and follow-up will be ensured by the same Cardiac Surgery Unit (CSU) team according to department's standard protocols. Participants in the Ferric carboxymaltose group will receive 1g of Ferric carboxymaltose diluted in 100 mL of IV isotonic serum saline, whereas participants in the Placebo group will receive 100 mL of IV Placebo
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St Joseph University, Beirut, Lebanon
Collaborators:
Saint-Joseph University
Vifor Pharma
Treatments:
Ferric Compounds
Criteria
Inclusion Criteria:

- Adult patients admitted for elective cardiac surgery under cardiopulmonary bypass,
with no exclusion criteria, and having signed an informed consent, will be enrolled in
the study.

Exclusion Criteria:

- Patients < 18 years

- Urgent surgery

- Off-pump cardiac surgery

- Redo cardiac surgery

- Preoperative anemia (Hb < 10g/l or Ht < 30%)

- Transfusion within 72h preoperatively

- Pregnancy

- History of asthma or other specific allergies

- History of allergy to iron

- Acute infection

- Hepatic insufficiency

- Renal insufficiency (creatinine Clearance < 30ml/min)