Anemia Clinical Trial
Official title:
Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac
surgery. The study will answer the question of whether preoperative treatment of anemia or
iron deficiency indeed improves transfusion needs (primary outcome) and important clinical
outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of
inclusion and exclusion criteria was deliberately chosen short so that this patient group
largely reflects today's clinical practice .
- Trial with medical product
Anemic or iron deficiency patients are randomized into treatment and placebo groups.
Treatment (see below) will be given the day before the operation (day -1) or a maximum of 2
days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days
prior to the operation in anemic patients (day -3). The treatment will not be disclosed to
the patient or the health care workers treating the patients during and after the operation.
Patients without anemia or iron deficiency will also be observed and the same postoperative
measurements performed. They will serve as a natural comparison group.
Treatment:
Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose
(Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml sodiumchloride (NaCl)
over 30 min.
Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum
folicum, Streuli Pharma AG, Uznach) 5 mg po.
The current transfusion and coagulation guidelines of the University Hospital of Zurich are
followed in both groups identically. Postoperatively on the regular ward a Hb transfusion
trigger of 80 g/L is applied
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