Randomized controlled trial.
Anaemia and iron deficiency are highly prevalent in cardiac surgery patients and may adversely affect postoperative rehabilitation. Moderate postoperative anaemia is typically corrected with oral iron supplements. Oral iron is however poorly absorbed after cardiac surgery and may cause debilitating gastrointestinal side-effects. It has also been shown that iron deficiency, even in the absence of anaemia, is associated with reduced exercise capacity, quality of life and survival in chronic heart failure patients. Here, treatment with intravenous iron improves clinical symptoms, exercise capacity and quality of life. It therefore seems desirable to replenish body iron stores rapidly after cardiac surgery with the aim to effectively correct anaemia, optimize exercise tolerance and improve patient wellbeing.
Modern intravenous iron formulations permit fast replenishment of body iron stores and have emerged as potential alternatives to oral iron. We hypothesize that single-dose intravenous iron therapy is superior to oral iron supplementation for the correction of anaemia following cardiac surgery. Moreover, we believe that single-dose intravenous iron therapy results in a greater postoperative exercise capacity, an improved quality of life and less fatigue.
The primary objective of the PICS-trial is to compare the efficacy of single-, high-dose intravenous iron infusion versus oral iron supplementation for the treatment of anaemia following cardiac surgery.
The PICS-trial is supported by an unrestricted research grant of 50.000 € from Pharmacosmos A/S (Holbæk, Denmark), the manufacturer of the study drug MonoFer®.
Start: 18 May 2021
End: 1 August 2022