Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery
Status:
Completed
Trial end date:
2021-01-02
Target enrollment:
Participant gender:
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