Efficacy Studies of Perioperative Recombinant Erythropoietin (rHuEPO) Alone
| Study | No. of patients | Evidence level | Design | rHuEPO intervention | Increase in hemoglobin or hematocrit | Decrease in allogeneic exposure | Decrease in allogeneic units used | Comment |
|---|---|---|---|---|---|---|---|---|
| Orthopedic surgery | ||||||||
| Canadian Orthopedic Preoperative Erythropoietin Study Group, 19934 | 208 | I | Multicentre, randomized, double blinded | 300 u/kg × 14 d (D−10–D+3) | S | S | S (Hgb 100–130 g/L) | |
| Placebo | 300 u/kg × 9 d (D−5–D+3) | S | NS | S (Hgb 100–130 g/L) | ||||
| de Andrade et al, 199620 | 316 | I | Multicentre, randomized, double blind | 300 u/kg × 15 d (D−10–D+4) | S (Hgb 100–130 g/L) | S (Hgb 100–130 g/L) | S (Hgb 100–130 g/L) | S increase in DVT (by ultrasonography) in Hgb × 130 g/L |
| Placebo | 100 u/kg × 15 d (D−10–D+4) | S (Hgb 100–130 g/L) | NS | S (Hgb 100–130 g/L) | ||||
| Faris, Ritter and Abels,199621 | 200 | I | Multicentre, randomized, double blind | 300 u/kg × 15 d (D−10–D+4) | NS (D−10 D0) | S (NS if Hgb > 130 g/mL | S | |
| Placebo | 100 u/kg × 15 d (D−10–D+4) | NS (D−10–D0) | S | S | ||||
| Goldberg et al, 199622 | 145 | I | Multicentre, randomized open label (dose finding) | 600 u/kg × 4 doses (D−21,D−14,D−7, D0) | NS between 2 dosing groups | NS between 2 dosing groups | NS between 2 dosing groups | |
| 300 u/kg× 15 d (D−10–D+4) | ||||||||
| Cardiac studies | ||||||||
| D’Ambra et al, 19925 | 41 | II | Randomized, double blind | 300 u/kg × 8 d (D−5–D+2) | S | |||
| Placebo | 150 u/kg × 8 d (D−5–D+2) | S | ||||||
| D’Ambra, 199623 | 182 | I | Randomized, double blind | 300 u/kg × 8 d (D−5–D+2) | NS (S if pts with surgical complications are excluded) | 7/126 receiving rHuEPO died v. 0/56 receiving placebo; 4/7 deaths were associated with vascular or thrombotic events | ||
| Placebo | 150 u/kg × 8 d (D−5–D+2) | NS | ||||||
| Kyo et al, 199224 | 95* | II | Multicentre, randomized, controlled | 3000 u 2–3 ×/wk × 4 wk | NS | NS | ||
| 6000 u 2–3 ×/wk× 4 wk | NS | NS | ||||||
| 9000 u 2–3 ×/wk× 4 wk | S | NS | ||||||
| Other surgery | ||||||||
| Heiss et al, 199625 (colorectal surgery) | 30 | II | Randomized, double blind | 150 u/kg q 2 d (D−10–D+2) | NS | NS | ||
| Placebo | ||||||||
S = significant, NS = not significant, u = units of rHuEPO, d = day, D = day no. (D0 is day of surgery, D− = preop day, D+ = postop day) DVT = deep vein thrombosis
↵* Subset of full study, includes only rHuEPO arm