Avoidance of allogeneic blood transfusions by treatment with epoetin beta
(recombinant human erythropoietin) in patients undergoing open- heart
surgery
O Sowade, H Warnke, P Scigalla, B Sowade, W Franke, D Messinger and J Gross
Clinic of Heart Surgery, Medical Faculty (Charite), Humboldt University
Berlin, Germany.
In a double-blind, randomized, placebo-controlled trial, we evaluated the
ability of epoetin beta (recombinant human erythropoietin) to avoid
allogeneic blood transfusions (ABT) and the associated risks in patients
undergoing primary elective open-heart surgery and in whom autologous blood
donation (ABD) was contraindicated. Seventy-six patients overall were
enrolled onto the trial and were randomly assigned to the two treatment
groups, 5 x 500 U/kg body weight (BW) epoetin beta or placebo intravenously
over 14 days preoperatively. All patients received 300 mg Fe2+ orally per
day during the treatment period. Preoperatively, the mean hemoglobin
increase was 1.50 g/dL greater in epoetin beta patients than in placebo
patients (95% confidence interval, 1.10 to 1.90 g/dL), allowing a rapid
return to the baseline value by the seventh postoperative day in most
epoetin beta patients. The mean volume of blood collected by intraoperative
isovolemic hemodilution was 562 mL (red blood cell mass, 274 mL) in the
epoetin beta group and 218 mL (red blood cell mass, 94 mL) in the placebo
group, respectively. Only four patients (11%) in the epoetin beta group
received an ABT, compared with 19 (53%) in the placebo group (P = .0003).
Epoetin beta was most useful in patients with a perioperative blood loss
greater than 750 mL, in those with a baseline hematocrit value less than
0.42, and in those aged > or = 60 years. The iron supplementation proved
adequate despite the fact that a significant decrease in ferritin (median,
48.1%) and transferrin saturation (median, 40.5%) was observed in epoetin
beta patients preoperatively. No influence of epoetin beta therapy on blood
pressure, laboratory safety variables, or the frequency of specific adverse
events was observed. Intravenous epoetin beta treatment of 5 x 500 U/kg BW
in combination with 300 mg Fe2+ orally per day administered over 14 days
preoperatively is an adequate therapy for increasing mean hemoglobin levels
by approximately 1.50 g/dL and reducing the allogeneic blood requirement in
patients undergoing elective open-heart surgery and in whom ABD is
contraindicated.
Volume 89,
Issue 2,
pp. 411-418,
01/15/1997
Copyright © 1997 by The American Society of Hematology
