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