THE EFFECT OF RECOMBINANT-HUMAN-ERYTHROPOIETIN ON THE EFFICACY OF AUTOLOGOUS BLOOD DONATION IN PATIENTS WITH LOW HEMATOCRITS - A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED TRIAL

Background: This randomized controlled study was undertaken to determi ne the effect of recombinant human erythropoietin (rHuEPO) on erythrop oiesis, autologous blood collection, and allogeneic transfusion risk i n elective surgery patients with low baseline hematocrits. Study Desig n and Methods: Patients (n = 204) with low baseline hematocrits (less than or equal to 39%), scheduled for orthopedic surgery within 25 to 3 5 days, were seen every 3 to 4 days for 21 days, At each visit, 450 mt of blood was collected if the hematocrit was greater than or equal to 33 percent, and rHuEPO (600 U/kg) or placebo was administered intrave nously. Results: One hundred seventy-three patients were evaluable. Th e number of autologous units collected from the rHuEPO and control gro ups, respectively, was 4.5 +/- 1.0 and 3.0 +/- 1.1 (p < 0.001), and ma rrow production of red cells increased by 668 +/- 222 and 353 +/- 155 mL over and above baseline production (p < 0.05). Allogeneic blood tra nsfusion was required by 31 percent of control and 20 percent of rHuEP O patients (p = 0.09), Excluding 8 patients who received >6 units, 29 percent of control and 14 percent of rHuEPO patients required allogene ic blood (p = 0.015). Logistic regression modeling determined that the risk of allogeneic transfusion was reduced by rHuEPO (p = 0.025). Con clusion: The use of rHuEPO stimulates erythropoiesis, permits the stor age of more autologous blood, and reduces allogeneic transfusion risk in patients with low hematocrits who are undergoing elective orthopedi c surgery. Additional studies are necessary to determine the optimal s chedules of rHuEPO administration and autologous blood collection as w ell as the cost-effectiveness of this strategy.