Efficacy Studies of rHuEPO With Preoperative Autologous Donation (PAD)
| Study | No. of patients | Evidence level | Design | rHuEPO intervention | Increase in preop Hgb or Hct | Increased PAD goal met | Decrease in allogeneic exposure | Decrease in allogeneic units used | Comment |
|---|---|---|---|---|---|---|---|---|---|
| Orthopedic surgery | |||||||||
| Baudoux, 199632 | 103 | I | Multicentre, randomized, placebo PAD goal = 4 units over 1–3 wk | 300 u/kg × 3 over 2–3 wk | S | NS | 59% of placebo pts were able to donate ≥ 4 units | ||
| 600 u/kg × 3 over 2–3 wk | S | NS | |||||||
| Beris, Mermillod and Levy, 199333 | 102 | I | Multicentre, randomized, controlled PAD goal = 3 units over 3 wk | 10 000 units 3×/wk at 2 and 4 wk preop | S | NS | NS | ||
| Biesma et al, 199434 | 60 | III | Nonrandomized, dose-finding PAD goal = 2 units on days 21 and 17 | 500 u/kg 2 ×/wk 3 wk | S | S increased PAD units collected at all dosages | |||
| 250 u/kg 2 ×/wk × 3 wk | S | ||||||||
| 125 u/kg 2 ×/wk × 3 wk | S | ||||||||
| Biesma et al, 199435 | 105 | I | Randomized, controlled PAD goal = 2 units over 1 wk | 500 u/kg 2 ×/wk × 3 wk | NS | NS | S | S | |
| Biesma et al, 199436 | 62 | II | Randomized, controlled PAD goal = 2 units on days 21 and 17 | 500 u/kg 2 ×/wk × 3 wk | S | S | |||
| Biesma et al, 199337 | 40 | II | Randomized, controlled PAD goal = 2 units on days 21 and 17 | 500 u/kg 2 ×/wk × 3 wk | S | NS | NS | NS | |
| Flecknoe-Brown, Ross and Fox, 199538 | 40 | V | Observation, no controlled PAD goal = 2 units/wk | 300 u/kg 2 ×/wk | Average 3.7 units PAD collected | ||||
| Goodnough et al, 199439 | 116 | I | Multicentre, randomized, placebo PAD goal = 6 units over 3 wk | 150 u/kg 2 ×/wk × 3 wk | NS | NS | NS | NS | S increased PAD units collected at all dosages |
| 300 u/kg 2 × /wk × 3 wk | NS | S | NS | NS | |||||
| 600 u/kg 2 ×/wk × 3 wk | S | S | NS | NS | |||||
| Goodnough et al, 198940 | 54 | II | Multicentre, rangomized, placebo PAD goal = 6 units over 3 wk | 600 u/kg 2 ×/wk × 3 wk | S | S | NS | NS | S increased PAD units collected |
| Maeda Hitoma and Hirata, 198941 (colorectal surgery) | 12 | III | Controlled PAD goal = 3 units over 3 wk | 6000 units 3 ×/wk | S | NS | NS | ||
| Mercuriali et al, 199542 | 38 | II | Randomized, double blind, placebo PAD goal = 6 units over 3 wk | 75 u/kg 2 ×/wk × 3 wk | NS | NS | S increased PAD units collected at 300 u/kg | ||
| 150 u/kg 2 ×/wk × 3 wk | S | NS | |||||||
| 300 u/kg 2 ×/wk × 3 wk | S | NS | |||||||
| Mercuriali et al, 199443 | 11 with RA | III | Historical controls PAD goal = 1 unit | 300 u/kg 2 ×/wk × 3 wk | S | NS | S | ||
| Mercuriali, 1993,27 1994,44 199645 | 50 | II | Randomized, Controlled PAD goal = 6 units over 3 wk | 300 u/kg 2 ×/wk × 3 wk | NS | NS | S increased PAD units and RBC volume collected at both dosages | ||
| 600 u/kg 2 ×/wk × 3 wk | |||||||||
| Price et al, 199646 | 204 | I | Multicentre, placebo PAD goal = 6 units over 3 wk | 600 u/kg 2 ×/wk × 3 wk | S | NS (S if pts with > 6 units or Hct 33%–39% excluded | S increased PAD units collected | ||
| Saikawa et al, 199447 | 22 (with RA) | V | Observation, open label PAD goal = 2–3 units | 400 u/kg q wk 600 u/kg q wk | 95% able to donate at least 1 unit | ||||
| Schlaeppi, Gunter and Nydegger, 199448 | 62 | II | Randomized, placebo PAD goal = 4 units over 4 wk | 100 u/kg q wk × 4 wk | S | NS | NS | ||
| 200 u/kg q wk × 4 wk | S | ||||||||
| Tasaki, Ohto and Motoki, 199549 | 20 | IV | Observation, historical control PAD goal = 3 units over 3 wk | 12 000 u/wk × 4 wk | S | NS | NS | ||
| Tryba, 199650 | 125 | II | Randomized, open label PAD goal = 6 units over 3 wk | 50 u/kg 2 ×/wk × 3 wk | NS | NS | S increased RBC volume collected in men at 100 and 150 u/kg dosages | ||
| 100 u/kg 2 ×/wk × 3 wk | NS | NS | |||||||
| 150 u/kg 2 ×/wk × 3 wk | NS | NS | |||||||
| Cardiac studies | |||||||||
| Hayashi et al, 199451 | 114 | I | Multicentre, placebo PAD goal = 2 units over 2 wk | 24 000 u/wk × 3 wk | NS | S | S | ||
| 12 000 u/wk × 3 wk | NS | NS | NS | ||||||
| Hayashi et al, 199352 | 26 | II | Controlled PAD goal = 4 units over 2 wk | 200 u/kg 3 ×/wk × 2 wk | S | S increased RBC mass donated | |||
| Konishi et al, 199353 | 10 | V | Observation | 100 u/kg q d × 2–12 wk | All pts increased Hgb from < 100 g/L to 110–145 g/L | ||||
| 600 u/kg q wk × 2–12 wk | |||||||||
| Kulier et al, 199354 | 24 | II | Randomized, control | 400 u/kg q wk × 4 wk | S | S | S | NS | S increased PAD units and RBC volume |
| PAD goal = 4 units over 4 wk | collected | ||||||||
| Kyo et al, 199224 | 137* | I | Multicentre, randomized, control PAD goal = 2–4 units | 3000 units 2–3 ×/wk × 5 wk | S if dose 3×/wk | S | |||
| 6000 units 2–3×/wk × 5 wk | S if dose 3×/wk | S | |||||||
| 9000 units 2–3×/wk × 5 wk | S if dose 3×/wk | S | |||||||
| Schmoeckel et al, 199355 | 43 | II | Randomized, placebo PAD goal = 1 unit | 100 u/kg 2 ×/wk × 4 wk | NS | NS | S increased RBC volume collected at 200–800 u/kg dosages | ||
| 200 u/kg 2 ×/wk × 4 wk | NS | NS | |||||||
| 400 u/kg 2 ×/wk × 4 wk | S | NS | |||||||
| 800 u/kg 2 ×/wk × 4 wk | S | NS | |||||||
| Walpoth et al, 199656 | 31 | II | Randomized, placebo PAD goal = 3 units over 3 wk | 150 u/kg 2 ×/wk × 4 wk | S | NS | NS | Placebo also collected 3 units | |
| 300 u/kg 2 ×/wk × 4 wk | S | NS | NS | ||||||
| Watanabe et al, 199257 | 40 | II | Randomized, placebo PAD goal = 2 units over 2 wk | 100 u/kg q d × 14 d | S | S | NS | ||
| 600 u/kg q wk × 2 wk | S | S | NS | ||||||
| Watanabe et al, 199158 | 18 | IV | Historical control PAD goal = 1 unit | 100 u/kg q d × 3 wk (with Fe) | S | ||||
| 100 u/kg q d × 3 wk (without Fe) | S | ||||||||
| Other surgery | |||||||||
| Braga et al, 199559 | 22 GI cancer | II | Randomized, open label PAD goal = 2 units over 2 wk | 300 u/kg × 1, then | NS | S increase, able to donate at least 1 unit | |||
| 100 u/kg × 3 doses | |||||||||
| Kajikawa et al, 199460 | 42 hepatic cancer | II | Randomized, control PAD goal = 3 units over 2–3 wk | 3000 u/d subcutaneously × 3 wk | S | S | |||
| Yamawaki et al, 199461 | 9 cervical cancer | V | Observation, historical control PAD goal = 3 units over 3 wk | 6000 units qod | All pts donated 3 units | No pt exposed to allogeneic blood | |||
S = significant, NS = not significant, Hgb = hemoglobin, Hct = hematocrit, u = units of rHuEPO, d = day, RA = rheumatoid arthritis, RBC = red blood cell, GI = gastrointestinal
↵* Subset of full study, includes only rHuEPO with PAD arm