Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery (PREFER-CABG)

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    210
  • sponsor
    Turku University Hospital
Updated on 15 February 2022
stenosis
coronary artery disease
heart disease
percutaneous coronary intervention
coronary artery stenosis
heart surgery
aortic valve disease
mitral valve disease
arterial disease
aortic valve surgery
revascularisation
three vessel disease

Summary

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.

Details
Condition Coronary Artery Disease, Postoperative Complications, Aortic Valve Stenosis, Mitral Valve Disease, Aortic Aneurysm, Thoracic
Treatment Ferric carboxymaltose, physiological saline
Clinical Study IdentifierNCT03574311
SponsorTurku University Hospital
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients presenting with cardiac disease requiring surgical operation
Open heart surgery is considered the best appropriate treatment strategy according to the current guidelines
significant three vessel disease
left main disease single, two or three vessel disease
two-vessel disease with proximal LAD stenosis
coronary artery disease requiring revascularization not amenable to percutaneous coronary intervention
Aortic valve disease requiring aortic valve surgery
Mitral valve disease requiring surgical mitral surgery
Combined surgery for revascularization and valve disease
surgery of ascending aorta
Have provided signed written informed consent

Exclusion Criteria

Age < 35 years
Patients requiring , emergency or salvage cardiac surgical operation
Participation in another clinical study or treatment with another investigational product 30 days prior to randomization
Moribund patient not expected to survive surgery 12 months after surgery
Active malignant disease with a short life expectancy, not eligible for surgery
Hemoglobin levels > 155 g/dL for women and >167 g/dl for men (upper reference limits for TYKSlab)
Ferritin levels >150 ug/l for women and >400 ug/l for men
Renal dialysis therapy for chronic renal failure or severe preoperative renal impairment (eGFR<30ml/min)
Study treatment can't be infused during the required time window: minimum 48 hours and maximum 21 days before the operation
Ongoing oral or parenteral iron medication at the time of randomization
Iron or haemoglobin metabolism or synthesis disorders
Primary or secondary hemochromatosis (in males and postmenopausal females, a serum ferritin value of over 300 ng/mL (670 pmol/L); and in premenopausal females, a serum ferritin value of over 150[17] or 200[18] ng/mL (330 or 440 pmol/L) indicates iron overload)
Porphyria cutanea tarda
Liver failure (Child-Pugh class B or C)
Pregnancy
Body weight less than 50kg
Ongoing antibiotic treatment other than prophylactic urine tract infection antibiotics
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