Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective Coronary Artery Bypass Grafting

A Phase IV Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective Coronary Artery Bypass Grafting - PREFER-CABG

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004901-41-FI

Enrollment

220

Registered

2018-04-06

Start date

2018-04-19

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing elective coronary artery bypass grafting surgery, the study investigates the prevention of postoperative infections and blood transfusions.

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing non-urgent and non-emergent coronary artery bypass grafting surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: Iron transport and iron storage parameters above normal population values and iron or hemoglobin metabolism disorders (e.g. hemochromatosis, thalassemia). Need for urgent or emergent coronary surgery. Concomitant surgery other than coronary artery surgery planned.

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate if preoperative ferric carboxymaltose administration is effective in preventing postoperative infections and blood transfusions in patients undergoing coronary artery bypass grafting surgery.;Secondary Objective: Investigate if preoperative ferric carboxymaltose administration is effective in improving survival and cardiac function in patients undergoing coronary artery bypass grafting surgery.;Primary end point(s): Postoperative in-hospital nosocomial infections and/or blood transfusions.;Timepoint(s) of evaluation of this end point: In-hospital stay for coronary surgery	—

Measure

Time frame

Main Objective: Investigate if preoperative ferric carboxymaltose administration is effective in preventing postoperative infections and blood transfusions in patients undergoing coronary artery bypass grafting surgery.;Secondary Objective: Investigate if preoperative ferric carboxymaltose administration is effective in improving survival and cardiac function in patients undergoing coronary artery bypass grafting surgery.;Primary end point(s): Postoperative in-hospital nosocomial infections and/or blood transfusions.;Timepoint(s) of evaluation of this end point: In-hospital stay for coronary surgery

—

Secondary

Measure	Time frame
Secondary end point(s): Survival, cardiac function, quality of life, pharmacoeconomics;Timepoint(s) of evaluation of this end point: 360 days postoperatively	—

Countries

Finland

Contacts

Public ContactHeart Center

Turku University Hospital

jarmo.gunn@tyks.fi35823130548

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026