Epoetin Alfa in Low Hematocrit Patients to Facilitate Autologous Blood Donation in Total Hip Replacement: A Randomized, Double-Blind, Placebo- Controlled, Dose-Ranging Study

Abstract

We investigated the safety and efficacy of preoperative epoetin alfa used in conjunction with preoperative autologous blood donation (PAD) in 40 anemic orthopedic surgical patients undergoing hip replacement surgery [hematocrit (Hct) ≤39%]. Patients were randomized 25–35 days before surgery to twice weekly intravenous (i.v.) epoetin alfa (300, 150, or 75 IU/kg) or placebo treatments supplemented with 200 mg i.v. iron. Epoetin alfa facilitated dose-dependent increases in PAD (4.3 units, 300 IU/kg; 3.4 units, 150 IU/kg; 3.0 units, 75 IU/kg; 2.1 units, placebo), and minimized reductions in Hct associated with repeated phlebotomy. All epoetin alfa doses were well tolerated and safe. Our results indicate that preoperative epoetin alfa dose-dependently stimulates erythropoiesis and facilitates PAD in anemic orthopedic patients, which may benefit patients by reducing their exposure to the risks of allogeneic transfusion, hastening recovery and discharge from hospital.

Iron deficiency syndromes and iron‐restricted erythropoiesis (CME)

“…A study of “very low” dose EPO therapy in autologous blood donors found that 400 U/kg administered over a 2‐week interval resulted in clinically significant erythropoiesis 28 . As shown in Table 2, 24,27,29‐31 patients treated with ESA therapy during aggressive autologous blood phlebotomy had 358 to 1102 mL (28%‐48% RBC) expansion over 25 to 35 days, or the equivalent of 2 to 5 blood units. The range in response (erythropoiesis) to dose (EPO) was not related to patient sex or age, 32,33 suggesting that iron‐restricted erythropoiesis accounted for the blunted and variable responses.…”

“…All patients received supplemental oral iron. Reproduced from Mercuriali et al., 29 with permission from AABB.…”

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“…In patients who were to undergo total hip replacement, rHuEPO facilitated dose-dependent increases in PAD amounting to 4.3 units (300 IU/kg), 3.4 units (150 IU/kg), and 3.0 units (75 IU/kg), as compared with 2.1 units with placebo, and it minimized reductions in hematocrit associated with repeated phlebotomy [42]. Treatment with rHuEPO resulted in rapid increases in RBC production (3.5 days) in nonanemic (hematocrit >39%) patients who were participating in an aggressive program for autologous blood donation [43,44].…”

Practice Guidelines for Perioperative Blood Management

“…[48][49][50][51][52][53][54][55][56][57][58][59][60][61][62] The literature is insufficient to evaluate the efficacy of erythropoietin with iron compared with erythropoietin without iron. [48][49][50][51][52][53][54][55][56][57][58][59][60][61][62] The literature is insufficient to evaluate the efficacy of erythropoietin with iron compared with erythropoietin without iron.…”