An open-label, randomized, parallel-group study of perioperative epoetin alfa versus standard of care for blood conservation in major elective spinal surgery: safety analysis
STUDY DESIGN Prospective, open-label, randomized, parallel-group study at 80 centers. OBJECTIVE To demonstrate there is no clinically important additional risk for deep vein thrombosis with perioperative use of epoetin alfa versus standard of care in spine surgery without prophylactic anticoagulation. SUMMARY OF BACKGROUND DATA Trials of epoetin alfa in orthopedic surgery that demonstrated no additional risk of thrombovascular events included perioperative pharmacologic anticoagulation. METHODS Subjects received epoetin alfa 600 U/kg subcutaneously once weekly starting 3 weeks before spinal surgery plus standard of care for blood conservation, or standard of care alone. Perioperative anticoagulation therapy was not permitted; mechanical deep vein thrombosis prophylaxis was allowed. Doppler imaging for deep vein thrombosis was done on postoperative day 4 (or day of discharge), or for suspected deep vein thrombosis. Deep vein thrombosis was diagnosed by Doppler result or adverse event report. The criterion for no additional risk of deep vein thrombosis was a 1-sided 97. 5% upper confidence limit < or =4% between groups. RESULTS Of the 680 subjects analyzed (340 in each treatment group), 16 (4. 7%) in the epoetin alfa group and 7 (2. 1%) in the standard of care group had a diagnosis of deep vein thrombosis either by Doppler or by adverse event report with normal Doppler. The between-group difference was 2. 6% (97. 5% upper confidence limit, 5. 4%). Deep vein thrombosis confirmed by Doppler (4. 1% vs. 2. 1%), other clinically relevant thrombovascular events (1. 5% vs. 0. 9%), and all adverse events combined (76. 5% vs. 73. 2%) occurred with similar frequency in the 2 treatment groups. CONCLUSION This study documented a higher incidence of deep vein thrombosis and similar rates of other clinically relevant thrombovascular events with epoetin alfa versus standard of care for blood conservation in subjects who did not receive prophylactic anticoagulation before spinal surgery. Antithrombotic prophylaxis should be considered when erythropoietin is used in the surgical setting.
Minimal effective dosage of recombinant human erythropoietin in spinal surgery
Clinical Orthopaedics and Related Research. 2003;412:71-6.
Preoperative autologous blood donation is one of the most widely used methods of autotransfusion. However securing a predetermined amount of blood (3 units of whole blood) may be difficult in patients with a low preoperative hematocrit. To determine the minimum effective pretreatment dosage of recombinant human erythropoietin required to secure an adequate amount of preoperative blood for autologous transfusion during posterior decompression and instrumentation fusion using the pedicle screw-rod system in the lumbar spine, a prospective randomized clinical trial was done. Forty-five patients who had a preoperative hematocrit less than 40% were selected and were divided blindly into three groups. Fifty units per kilogram of recombinant human erythropoietin seems to be the minimal effective dosage for securing an adequate amount of preoperative autologous blood donation.
The use of Epoetin alfa in complex spine deformity surgery
STUDY DESIGN A prospective, randomized trial comparing Epoetin alfa (Procrit) with placebo saline injection to determine effectiveness in increasing erythropoietic recovery in complex spine deformity surgery. OBJECTIVES To determine if Epoetin alfa can allow preoperative autologous donation completion more effectively and reduce perioperative homologous blood transfusion. SUMMARY OF BACKGROUND DATA The use of Epoetin alfa has been studied, primarily in the arthroplasty literature, for its effectiveness in decreasing transfusion requirements and increasing hemoglobin levels. It has not been studied in patients undergoing complex spine deformity surgery. METHODS A total of 48 patients were prospectively randomized into an Epoetin alfa group and a control group. All patients attempted to donate 4 units of preoperative autologous donation at weekly intervals; 40,000 units of Epoetin alfa were injected subcutaneously at the time of preoperative autologous donation in the Epoetin alfa group. Hematocrit levels were recorded weekly during the donation process and daily in the preoperative period. RESULTS Preoperative autologous donation was completed more effectively in the patients receiving Epoetin alfa. Epoetin alfa resulted in statistically higher hematocrit levels during preoperative autologous donation and perioperatively (P < 0.005). Homologous transfusion was decreased by 2.4 units and hospital stay was 1.8 days shorter in patients receiving Epoetin alfa. CONCLUSION Patients who received Epoetin alfa were able to complete preoperative autologous donation more effectively, increase erythropoietic recovery, decrease homologous transfusion requirements, and had shorter hospital stays.