Comparison Between Our Trial Results and Those of Other Studies in Patients With Preoperative rhEPO Therapy Without Autologous Blood Donation and With the Study Results of Biesma et al6
| Trial (indication) Preoperative Treatment With rhEPO/Placebo and Iron . | Trial Group . | Mean ± SD . | Rate of ABT (%) . | |||
|---|---|---|---|---|---|---|
| . | . | Baseline Hb (g/dL) . | Hb Change From Baseline (g/dL) . | Age (yr) . | Total Blood Loss (mL) . | . |
| Our trial (cardiac surgery) 5 × 500 U rhEPO/kg (total, 2,500 U/kg) over 14 days IV; 300 mg Fe2+/d orally over 14 d | rhEPO (n = 36) | 14.31 ± 0.98 | 1.53 ± 0.82 | 54.3 ± 8.6 | 939 ± 493 | 11.1 |
| Placebo (n = 36) | 13.78 ± 1.03 | 0.19 ± 0.92 | 57.0 ± 8.8 | 894 ± 557 | 52.8 | |
| Laupacis (orthopedic) 10 × 300 U rhEPO/kg (total, 3,000 U/kg) over 10 days SC; 3 × 300 mg iron-sulfate/d orally over 19 d | rhEPO (n = 77) | 13.7 ± 1.2 | 0.88 ( — ) | 64.0 ± 12 | 674 ± 4465-150 | 23 |
| Placebo (n = 78) | 13.8 ± 1.2 | −0.26 ( — ) | 63.0 ± 12 | 725 ± 3715-150 | 44 | |
| Kyo (cardiac surgery) 4 or 6 × 9,000 U rhEPO (total, 700-1,000 U/kg) over 14 days IV; 6 × 40 mg Fe IV over 14 d | rhEPO (n = 18) | 13.25 ± 1.90 | 0.8 (0.3)5-151 | 51.3 ± 14.5 | 1,250 (−)5-152 | 50.0 |
| Control (n = 26) | 13.80 ± 2.00 | −0.5 (0.2)5-151 | 51.2 ± 13.9 | 1,350 (−)5-152 | 57.7 | |
| Biesma (orthopedic) 6 × 500 rhEPO U/kg (total, 3,000 U/kg) over 21 days SC; 3 × 66 mg Fe2+/d orally over 21 dρ | rhEPO (n = 50) | 14.05 ± 1.00 | −0.27 ± 1.24 | 66.2 ± 8.0 | 1,225 ± 748 | 10.0¶ |
| Control (n = 45) | 13.82 ± 1.19 | −1.77 ± 0.69 | 65.9 ± 10.4 | 1,194 ± 608 | 35.6¶ | |
| Trial (indication) Preoperative Treatment With rhEPO/Placebo and Iron . | Trial Group . | Mean ± SD . | Rate of ABT (%) . | |||
|---|---|---|---|---|---|---|
| . | . | Baseline Hb (g/dL) . | Hb Change From Baseline (g/dL) . | Age (yr) . | Total Blood Loss (mL) . | . |
| Our trial (cardiac surgery) 5 × 500 U rhEPO/kg (total, 2,500 U/kg) over 14 days IV; 300 mg Fe2+/d orally over 14 d | rhEPO (n = 36) | 14.31 ± 0.98 | 1.53 ± 0.82 | 54.3 ± 8.6 | 939 ± 493 | 11.1 |
| Placebo (n = 36) | 13.78 ± 1.03 | 0.19 ± 0.92 | 57.0 ± 8.8 | 894 ± 557 | 52.8 | |
| Laupacis (orthopedic) 10 × 300 U rhEPO/kg (total, 3,000 U/kg) over 10 days SC; 3 × 300 mg iron-sulfate/d orally over 19 d | rhEPO (n = 77) | 13.7 ± 1.2 | 0.88 ( — ) | 64.0 ± 12 | 674 ± 4465-150 | 23 |
| Placebo (n = 78) | 13.8 ± 1.2 | −0.26 ( — ) | 63.0 ± 12 | 725 ± 3715-150 | 44 | |
| Kyo (cardiac surgery) 4 or 6 × 9,000 U rhEPO (total, 700-1,000 U/kg) over 14 days IV; 6 × 40 mg Fe IV over 14 d | rhEPO (n = 18) | 13.25 ± 1.90 | 0.8 (0.3)5-151 | 51.3 ± 14.5 | 1,250 (−)5-152 | 50.0 |
| Control (n = 26) | 13.80 ± 2.00 | −0.5 (0.2)5-151 | 51.2 ± 13.9 | 1,350 (−)5-152 | 57.7 | |
| Biesma (orthopedic) 6 × 500 rhEPO U/kg (total, 3,000 U/kg) over 21 days SC; 3 × 66 mg Fe2+/d orally over 21 dρ | rhEPO (n = 50) | 14.05 ± 1.00 | −0.27 ± 1.24 | 66.2 ± 8.0 | 1,225 ± 748 | 10.0¶ |
| Control (n = 45) | 13.82 ± 1.19 | −1.77 ± 0.69 | 65.9 ± 10.4 | 1,194 ± 608 | 35.6¶ | |
Abbreviations: IV, intravenous; SC, subcutaneous; ( — ), SD not available.
Only intraoperative blood loss specified in the report.
Kyo et al.23
Estimated by figure.22
ρ Autologous blood donation 21 and 17 days preoperatively; data not included in publication6; D.H. Biesma and W. Franke, personal communciation, October 1993.
Additionally, autologous blood was administered in 88.9% of controls and 46.0% of rhEPO patients.