PREFER-CBP trial

Efficacy of Ferric Carboxymaltose in Reducing Postoperative Blood Transfusions and Nosocomial Infections after Cardiac Surgery – Randomized, Double-blinded PREFER-CPB –trial

Background: Iron supplementation may reduce the incidence of postoperative anemia and need for blood transfusions (BT) as well as nosocomial infections in patients undergoing surgery, but this concept has not been tested in cardiac surgery in a prophylactic setting. We sought to assess the efficacy and safety of prophylactic intravenous iron supplementation in patients undergoing open-heart surgery.

Methods: In this investigator-initiated industry-sponsored single-center randomized double-blind parallel group trial, we enroll patients undergoing coronary bypass, aortic or mitral valve or ascending aortic surgery and fulfilling prespecified iron blood test safety criteria. Patients are randomized to receive either a single intravenous 1000 mg dose of ferric carboxymaltose (FCM) or placebo (saline only). Independent unblinded study nurse administers the infusion with masked lines and cannula 2 –21 days before surgery. Primary efficacy endpoint is a composite of BT over two units and nosocomial infection during the index hospitalization. Trial was registered in Eudract (2017-004901-41).

Authors

Tuomas O. Kiviniemi MD, PhD1,2; Vesa Anttila MD, PhD 1,3; Kristiina Pälve MD, PhD 1,3; Marko Vesanen MD 2,4; Joonas Lehto MD, PhD 1,2; Markus Malmberg MD, PhD 1,3; Tuija Vasankari MS1; K.E. Juhani Airaksinen MD, PhD 1,2; Jarmo Gunn MD, PhD 1,3

1 Heart Center, Turku University Hospital, Turku, Finland

2 Department of Clinical Medicine, University of Turku, Turku, Finland

3 Department of Surgery, University of Turku, Turku, Finland

4 Medicine, Turku University Hospital, Turku, Finland