Effect of rFVIIa and placebo treatment on warfarin-treated bleeding duration and blood loss
| . | No. . | Baseline (B0), mean ± SD . | After warfarin treatment (B1), mean ± SD . | After rFVIIa or placebo treatment (B2) LSM (CV) . | Ratio of means at B2 (rFVIIa vs placebo) . | P* . |
|---|---|---|---|---|---|---|
| Bleeding duration, min | ||||||
| Experiment 1 | 11 | 12.7 ± 2.7 | 20.6 ± 5.6 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 18.7 ± 3.1 | 29.5 ± 6.5 | 26.3 (0.2) | ||
| 5 μg/kg rFVIIa | 6 | 23.0 ± 10.3 | 36.9 ± 6.1 | 28.0 (0.2) | 1.1 | .474 |
| 10 μg/kg rFVIIa | 6 | 19.8 ± 3.9 | 33.7 ± 7.3 | 23.7 (0.2) | 0.9 | .252 |
| 20 μg/kg rFVIIa | 13 | 20.1 ± 3.7 | 29.9 ± 7.0 | 28.8 (0.2) | 1.1 | .164 |
| 40 μg/kg rFVIIa | 12 | 20.7 ± 2.8 | 32.3 ± 6.5 | 28.9 (0.2) | 1.1 | .156 |
| 80 μg/kg rFVIIa | 24 | 18.6 ± 4.1 | 31.9 ± 6.2 | 27.7 (0.2) | 1.1 | .347 |
| Blood loss, mL | ||||||
| Experiment 1 | 11 | 2.4 ± 1.1 | 3.8 ± 2.0 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 4.0 ± 2.4 | 5.6 ± 2.2 | 4.7 (0.5) | ||
| 5 μg/kg rFVIIa | 6 | 4.9 ± 2.6 | 9.7 ± 6.5 | 5.6 (0.5) | 1.2 | .392 |
| 10 μg/kg rFVIIa | 6 | 4.3 ± 1.7 | 6.1 ± 2.6 | 4.0 (0.5) | 0.9 | .447 |
| 20 μg/kg rFVIIa | 13 | 4.0 ± 2.3 | 4.9 ± 3.1 | 5.6 (0.5) | 1.2 | .226 |
| 40 μg/kg rFVIIa | 12 | 4.5 ± 2.0 | 4.9 ± 1.8 | 5.9 (0.5) | 1.3 | .150 |
| 80 μg/kg rFVIIa | 24 | 3.8 ± 2.3 | 5.3 ± 2.4 | 5.3 (0.5) | 1.1 | .312 |
| . | No. . | Baseline (B0), mean ± SD . | After warfarin treatment (B1), mean ± SD . | After rFVIIa or placebo treatment (B2) LSM (CV) . | Ratio of means at B2 (rFVIIa vs placebo) . | P* . |
|---|---|---|---|---|---|---|
| Bleeding duration, min | ||||||
| Experiment 1 | 11 | 12.7 ± 2.7 | 20.6 ± 5.6 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 18.7 ± 3.1 | 29.5 ± 6.5 | 26.3 (0.2) | ||
| 5 μg/kg rFVIIa | 6 | 23.0 ± 10.3 | 36.9 ± 6.1 | 28.0 (0.2) | 1.1 | .474 |
| 10 μg/kg rFVIIa | 6 | 19.8 ± 3.9 | 33.7 ± 7.3 | 23.7 (0.2) | 0.9 | .252 |
| 20 μg/kg rFVIIa | 13 | 20.1 ± 3.7 | 29.9 ± 7.0 | 28.8 (0.2) | 1.1 | .164 |
| 40 μg/kg rFVIIa | 12 | 20.7 ± 2.8 | 32.3 ± 6.5 | 28.9 (0.2) | 1.1 | .156 |
| 80 μg/kg rFVIIa | 24 | 18.6 ± 4.1 | 31.9 ± 6.2 | 27.7 (0.2) | 1.1 | .347 |
| Blood loss, mL | ||||||
| Experiment 1 | 11 | 2.4 ± 1.1 | 3.8 ± 2.0 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 4.0 ± 2.4 | 5.6 ± 2.2 | 4.7 (0.5) | ||
| 5 μg/kg rFVIIa | 6 | 4.9 ± 2.6 | 9.7 ± 6.5 | 5.6 (0.5) | 1.2 | .392 |
| 10 μg/kg rFVIIa | 6 | 4.3 ± 1.7 | 6.1 ± 2.6 | 4.0 (0.5) | 0.9 | .447 |
| 20 μg/kg rFVIIa | 13 | 4.0 ± 2.3 | 4.9 ± 3.1 | 5.6 (0.5) | 1.2 | .226 |
| 40 μg/kg rFVIIa | 12 | 4.5 ± 2.0 | 4.9 ± 1.8 | 5.9 (0.5) | 1.3 | .150 |
| 80 μg/kg rFVIIa | 24 | 3.8 ± 2.3 | 5.3 ± 2.4 | 5.3 (0.5) | 1.1 | .312 |
LSM indicates least-square mean, adjusted for Biopsy 1 (B1); and CV, coefficient of variance.
The model used was a generalized linear model with logarithmic link and γ distribution with B1 as a covariate.