Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective Coronary Artery Bypass Grafting
Phase 1
- Conditions
- Patients undergoing elective coronary artery bypass grafting surgery, the study investigates the prevention of postoperative infections and blood transfusions.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004901-41-FI
- Lead Sponsor
- Hospital District of Southwestern Finland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 220
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Survival, cardiac function, quality of life, pharmacoeconomics;Timepoint(s) of evaluation of this end point: 360 days postoperatively