Pre-operative treatment with Erythropoietin and iron supplement for prevention of perioperative blood transfusion in cardiac surgery

Preoperative anemia is a predictor for the outcome after cardiac surgery, and
specially leads to increased transfusion of red blood cells (RBC). In patients
undergoing cardiac surgery, transfusion is associated with increased mortality
and morbidity. Allogenic blood products increase the risk for postoperative
infections, mortality and hospital stay. In addition, hospital costs increases
by the donation of RBC in the cardiothoracic program in our institution.
In an earlier study of our department, we found that five- and nine-year
survival in non-transfused patients undergoing coronary artery bypass grafting
(CABG) was better than that of transfused patients and even better than matched
populations. Blood transfusion was also identified as an independent predictor
of early mortality after CABG. In addition, female gender, lower body surface
area (BSA), low preoperative Hemoglobin (Hb), previous cardiac surgery,
emergency operation and low preoperative creatinin clearance were found to be
independent risk factors for receiving RBC units. Therefore, we sought to
create a clinical pathway to minimize transfusion of red blood cells in a
selected group of cardiac patients with an increased risk for blood
transfusions in our cardiac surgery program.

Primary objective: To determine the reduction of number of patients who receive
blood transfusion perioperatively in the group pre-treated with erythropoietin
and iron supplement compared to the control patients.

This is a prospective single center study performed in a randomised setting.

Group 1: pre-treated group: patients receive up to two boluses of
erythropoietin subcutaneously and one bolus of iron supplement intravenously
administered at the outpatient clinic by a special trained nurse prior to
surgery. Group 2: control group: no pre-treatment with either medication.

The patients in the pre-treated group receive up to 2 times a bolus of
erythropoietin and one bolus of iron supplement intravenously administered by a
special trained nurse prior to surgery. The surgical intervention that the
patients in both groups will undergo is the standard procedure at the Catharina
hospital. Apart from the study drug administration in the pre-treated group, no
additional invasive procedures will be undertaken. During the hospital stay,
next to routine in-hospital assessments on clinical condition and peri- and
post-operative data collection, patients will be inquired about symptoms and
possible complications. Patients will be requested to come for a follow-up
visit 30 days after surgery (+ 7 days) for a follow-up visit, at which time
information will be collected concerning clinical symptoms and complications
and current medication.
No benefits are expected in the control group. In the pre-treated group,
epoetin alfa and Ferinject injections would improve the outcome by increasing
the preoperative Hb value without additional risks.