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 | | |