1.
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
Stowell CP, Jones SC, Enny C, Langholff W, Leitz G
Spine. 2009;34((23):):2479-85.
Abstract
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.
2.
An open-label, randomized study to compare the safety and efficacy of perioperative epoetin alfa with preoperative autologous blood donation in total joint arthroplasty
Stowell CP, Chandler H, Jove M, Guilfoyle M, Wacholtz MC
Orthopedics. 1999;22((1, Suppl):):s105-12.
Abstract
A multicenter, randomized, open-label, parallel-group study was conducted to compare the safety and efficacy of perioperative recombinant human erythropoietin (Epoetin alfa) with the safety and efficacy of preoperative autologous donation (PAD) in total joint arthroplasty. A total of 490 patients scheduled for total joint (i.e., hip or knee) surgery and having hemoglobin (Hb) levels > or = 11 to < or = 13 g/dL were randomized to receive weekly doses of subcutaneous Epoetin alfa on preoperative Days -21, -14, and -7, and on the day of surgery, or to participate in a PAD program. The mean baseline Hb level in both groups was 12.3+/-0.6 g/dL, increasing to 13.8 g/dL in the Epoetin alfa-treated group and decreasing to 11.1 g/dL in the PAD group before or on the day of surgery. In the PAD group, 156/219 (71.2%) patients were transfused with autologous blood, and 42/219 (19.2%) patients were transfused with allogeneic blood. A smaller proportion, 27/209 (12.9%) patients, in the Epoetin alfa-treated group were transfused with allogeneic blood (P = .078 compared with the PAD group). Moreover, patients in the PAD group received a total of 325 units of blood (79 allogeneic units and 246 autologous units) compared with patients in the Epoetin alfa group who received a total of 54 units of blood. The mean postoperative Hb level was 11.0 g/dL in the Epoetin alfa-treated group and 9.2 g/dL in the PAD group. Compared with the PAD arm, mean Hb levels measured preoperatively, postoperatively on Day 1, and at discharge visits were significantly greater in the Epoetin alfa-treated arm (P < .0001 ).
3.
Perceptions and preferences of autologous blood donors
Lee SJ, Liljas B, Churchill WH, Popovsky MA, Stowell CP, Cannon M, Johannesson M
Transfusion. 1998;38((8):):757-763.
4.
Epoetin alfa benefits patients at risk for transfusion in orthopedic surgery
Stowell CP, deAndrade JR, Jove M, Landon G, Frei D, Guilfoyle M, Young D
Transfusion. 1996;36((9S):):29S.. Abstract No. S114.