Phase
Condition
Cardiac Surgery
Anemia
Treatment
0.9% sodium chloride solution
Monoferric Injectable Product
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (CPB) and who meet all following criteria:
Age greater than 18 years old
Preoperative iron-deficiency with or without anemia (defined as Hb <130 g/L) withany one of:
ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or
reticulocyte Hb content < 29 pg, where available
Exclusion
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the study:
specialized procedures (e.g., ventricular assist device insertion, thoracoabdominalaneurysm, complex adult congenital surgery and heart transplant)
established contraindications to IV iron:
hypersensitivity to the iron product
history of >2 food and/or drug allergic reactions (excluding drug intolerance)
non-iron deficiency anemias such as myelodysplastic syndrome
history of iron overload or disturbances in use of iron such as hemochromatosisor hemosiderosis
decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
active infection
preoperative unstable hemodynamics defined as the requirement for vasopressors orinotropes, or active bleeding (as noted in the clinical record and/or defined as arequirement for red blood cell transfusion for ongoing clinical bleeding)
refusal of blood products for religious or other reasons
known pregnancy
already enrolled in this trial
enrolment in another interventional trial which may impact anemia or transfusionmanagement (for example, a trial of hemostatic therapies, such as tranexamic acid)
receipt of intravenous iron at any point in the 6 weeks prior to randomization
Study Design
Connect with a study center
Kingston Health Sciences Centre
Kingston, Ontario K7L 3N6
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
Toronto General Hospital - University Health Network
Toronto, Ontario M5G 2C4
CanadaActive - Recruiting
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