Question: In patients having total hip joint arthroplasty,
does erythropoietin (epoetin alfa) (Eprex; Janssen-Ortho Inc.,
Toronto, Ontario, Canada) reduce the need for allogeneic blood transfusions?
Design: Randomized, double-blind, placebo-controlled
trial with 5-day follow-up.
Setting: 13 teaching hospitals and 4 community hospitals
in Canada.
Patients: 216 patients scheduled for total hip joint
arthroplasty had a preoperative hemoglobin concentration between
98 and 137 g/L and did not predonate blood. Exclusion criteria
were rheumatoid arthritis, recent gastrointestinal or
intracranial bleeding, iron deficiency, seizures, blood dyscrasias,
uncontrolled hypertension, need for revision arthroplasty, and necessity
for red blood-cell-salvage devices. 201 patients (93%)
(mean age, 68 years; 90% women) were included in the intention-to-treat analysis.
Intervention: Beginning 4 weeks before surgery,
patients were allocated to 4 weekly injections of high-dose epoetin
alfa (40,000 U, n = 44), low-dose epoetin alfa
(20,000 U, n = 79), or placebo (n = 78),
at a patient distribution ratio of 3:5:5, respectively. All patients received
450 mg/day of oral iron, from 42 days before surgery until
hospital discharge.
Main outcome measures: Allogeneic blood transfusion. Secondary
outcome measures were changes in reticulocyte count and hemoglobin
concentration, adverse events, and incidence of thromboembolic disease.
Results: The number of patients requiring a blood
transfusion in both the high-dose (P = 0.001) and the low-dose
(P = 0.003) epoetin group was lower than in the placebo
group (table). The increase in reticulocyte count in patients who
received high-dose epoetin alfa (58.8 ¥ 109 cells/L)
was greater than the increase in patients who received low-dose epoetin
alfa (37.0 ¥ 109 cells/L) or placebo (1.8 ¥ 109
cells/L) (P £ 0.003 for both comparisons). Both
epoetin groups had substantial increases in hemoglobin concentration
(high-dose, 19.5 g/L and low-dose, 17.2 g/L) compared
with the placebo group (1.2 g/L) (P < 0.001).
The groups did not differ for incidence of any deep venous thrombosis
or pulmonary embolism (4.5%, 6.3%, and 7.7% for
the high-dose epoetin, low-dose epoetin, and placebo groups,
respectively). The groups did not differ significantly for serious
adverse events (6.5%, 3.5%, and 8.5%, respectively).
Conclusion: In patients having total hip joint arthroplasty,
preoperative epoetin alfa reduced the need for allogeneic blood
transfusions.