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, 1996 (32) | 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, 1993 (33) | 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, 1994 (34) | 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, 1994 (35) | 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, 1994 (36) | 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, 1993 (37) | 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, 1995 (38) | 40 | V | Observation, no controlled PAD goal = 2 units/wk | 300 u/kg 2 ×/wk | Average 3.7 units PAD collected | ||||
Goodnough et al, 1994 (39) | 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, 1989 (40) | 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, 1989 (41) (colorectal surgery) | 12 | III | Controlled PAD goal = 3 units over 3 wk | 6000 units 3 ×/wk | S | NS | NS | ||
Mercuriali et al, 1995 (42) | 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, 1994 (43) | 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) 1996 (45) | 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, 1996 (46) | 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, 1994 (47) | 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, 1994 (48) | 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, 1995 (49) | 20 | IV | Observation, historical control PAD goal = 3 units over 3 wk | 12 000 u/wk × 4 wk | S | NS | NS | ||
Tryba, 1996 (50) | 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, 1994 (51) | 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, 1993 (52) | 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, 1993 (53) | 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, 1993 (54) | 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, 1992 (24) | 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, 1993 (55) | 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, 1996 (56) | 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, 1992 (57) | 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, 1991 (58) | 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, 1995 (59) | 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, 1994 (60) | 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, 1994 (61) | 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