This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
210
A single dose of drug or placebo is administered preoperatively to participants
Single infusion 100 ml physiological saline infusion preoperatively
Turku University Hospital
Turku, Finland
RECRUITINGIncidence of allogeneic blood transfusion and/or nosocomial infection
Composite of transfused red blood cell units and/or nosocomial infection
Time frame: 0-90 days
Mortality
All-cause mortality
Time frame: 0-90 days
ICU/CCU days
Days in the ICU (intensive care unit) and/or CCU (cardiac care unit)
Time frame: 0-90 days
Perioperative myocardial infarction
MI (myocardial infarction) assessed by postoperative CK-Mbm or Troponin t levels
Time frame: 3 days
Length of stay
Days in hospital
Time frame: 0-90 days
Days on vasoactive drugs
Days on vasopressors (e.g. epinephrine, norepinephrine, milrinone etc.)
Time frame: 0-90 days
Ventilator free days
Days not on ventilator (intubated or non-invasive ventilation)
Time frame: 0-90 days
AKI (acute kidney injury)
Rate of acute renal failure
Time frame: 0-90 days
New onset atrial fibrillation (AF) or flutter
New AF or flutter (i.e. patient without previous history of AF/flutter) assessed from ECG-telemetry during index hospitalization or ECG-verified AF/flutter after discharge
Time frame: 0-90 days
Acute heart failure
Acute congestive heart failure (diagnosed by a clinician) requiring hospitalization
Time frame: 90 days
Worsening heart failure
Worsening to NYHA -class (New York Heart Association) III/IV or readmission for heart failure
Time frame: 0-90 days
Health related quality of life
Assessed with self-reporting questionnaire
Time frame: 12 months
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