Effect of rFVIIa and placebo treatment on warfarin-treated coagulation parameters
| . | No. . | Baseline at B0, mean ± SD . | After warfarin treatment at B1, mean ± SD . | After rFVIIa or placebo treatment at B2, mean ± SD . | P* . | After rFVIIa or placebo treatment at B3, mean ± SD . |
|---|---|---|---|---|---|---|
| aPTT, seconds | ||||||
| Experiment 1 | 11 | 29.8 ± 1.6 | 45.2 ± 6.0 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 28.3 ± 3.1 | 44.9 ± 6.6 | 44.6 ± 6.4 | 43.0 ± 5.4 | |
| 5 μg/kg rFVIIa | 6 | 27.5 ± 1.2 | 41.9 ± 2.3 | 39.3 ± 2.2 | .080 | 41.0 ± 2.3 |
| 10 μg/kg rFVIIa | 6 | 29.1 ± 2.4 | 44.8 ± 4.1 | 39.5 ± 3.5 | .014 | 44.2 ± 6.4 |
| 20 μg/kg rFVIIa | 13 | 29.4 ± 2.6 | 45.2 ± 8.3 | 40.9 ± 10.0 | .012 | 40.1 ± 4.8 |
| 40 μg/kg rFVIIa | 12 | 28.9 ± 1.1 | 45.2 ± 4.1 | 38.2 ± 3.2 | .002 | 39.3 ± 3.6 |
| 80 μg/kg rFVIIa | 24 | 29.3 ± 2.9 | 49.2 ± 9.4 | 38.8 ± 5.9 | < .001 | 39.3 ± 5.2 |
| PT, seconds | ||||||
| Experiment 1 | 11 | 14.2 ± 0.3 | 31.1 ± 4.6 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 13.0 ± 0.6 | 27.3 ± 2.9 | 26.7 ± 2.4 | 25.9 ± 3.0 | |
| 5 μg/kg rFVIIa | 6 | 13.3 ± 0.7 | 28.3 ± 2.3 | 17.9 ± 4.9 | < .001 | 22.9 ± 2.5 |
| 10 μg/kg rFVIIa | 6 | 13.4 ± 0.6 | 27.5 ± 1.2 | 15.7 ± 0.6 | < .001 | 20.6 ± 1.1 |
| 20 μg/kg rFVIIa | 13 | 13.3 ± 0.9 | 26.4 ± 1.5 | 14.9 ± 0.8 | < .001 | 19.5 ± 1.9 |
| 40 μg/kg rFVIIa | 12 | 12.9 ± 0.5 | 26.8 ± 2.3 | 14.7 ± 0.8 | < .001 | 17.9 ± 1.2 |
| 80 μg/kg rFVIIa | 24 | 13.3 ± 0.6 | 30.4 ± 2.1 | 15.0 ± 1.0 | < .001 | 18.0 ± 1.7 |
| INR | ||||||
| Experiment 1 | 11 | 1.1 ± 0.04 | 2.5 ± 0.3 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 1.0 ± 0.1 | 2.5 ± 0.3 | 2.5 ± 0.3 | 2.4 ± 0.3 | |
| 5 μg/kg rFVIIa | 6 | 1.1 ± 0.1 | 2.7 ± 0.3 | 1.5 ± 0.5 | < .001 | 2.1 ± 0.3 |
| 10 μg/kg rFVIIa | 6 | 1.1 ± 0.1 | 2.6 ± 0.2 | 1.3 ± 0.1 | < .001 | 1.8 ± 0.1 |
| 20 μg/kg rFVIIa | 13 | 1.1 ± 0.1 | 2.4 ± 0.2 | 1.2 ± 0.1 | < .001 | 1.7 ± 0.2 |
| 40 μg/kg rFVIIa | 12 | 1.0 ± 0.1 | 2.5 ± 0.3 | 1.2 ± 0.1 | < .001 | 1.5 ± 0.1 |
| 80 μg/kg rFVIIa | 24 | 1.1 ± 0.1 | 2.8 ± 0.2 | 1.2 ± 0.1 | < .001 | 1.5 ± 0.2 |
| . | No. . | Baseline at B0, mean ± SD . | After warfarin treatment at B1, mean ± SD . | After rFVIIa or placebo treatment at B2, mean ± SD . | P* . | After rFVIIa or placebo treatment at B3, mean ± SD . |
|---|---|---|---|---|---|---|
| aPTT, seconds | ||||||
| Experiment 1 | 11 | 29.8 ± 1.6 | 45.2 ± 6.0 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 28.3 ± 3.1 | 44.9 ± 6.6 | 44.6 ± 6.4 | 43.0 ± 5.4 | |
| 5 μg/kg rFVIIa | 6 | 27.5 ± 1.2 | 41.9 ± 2.3 | 39.3 ± 2.2 | .080 | 41.0 ± 2.3 |
| 10 μg/kg rFVIIa | 6 | 29.1 ± 2.4 | 44.8 ± 4.1 | 39.5 ± 3.5 | .014 | 44.2 ± 6.4 |
| 20 μg/kg rFVIIa | 13 | 29.4 ± 2.6 | 45.2 ± 8.3 | 40.9 ± 10.0 | .012 | 40.1 ± 4.8 |
| 40 μg/kg rFVIIa | 12 | 28.9 ± 1.1 | 45.2 ± 4.1 | 38.2 ± 3.2 | .002 | 39.3 ± 3.6 |
| 80 μg/kg rFVIIa | 24 | 29.3 ± 2.9 | 49.2 ± 9.4 | 38.8 ± 5.9 | < .001 | 39.3 ± 5.2 |
| PT, seconds | ||||||
| Experiment 1 | 11 | 14.2 ± 0.3 | 31.1 ± 4.6 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 13.0 ± 0.6 | 27.3 ± 2.9 | 26.7 ± 2.4 | 25.9 ± 3.0 | |
| 5 μg/kg rFVIIa | 6 | 13.3 ± 0.7 | 28.3 ± 2.3 | 17.9 ± 4.9 | < .001 | 22.9 ± 2.5 |
| 10 μg/kg rFVIIa | 6 | 13.4 ± 0.6 | 27.5 ± 1.2 | 15.7 ± 0.6 | < .001 | 20.6 ± 1.1 |
| 20 μg/kg rFVIIa | 13 | 13.3 ± 0.9 | 26.4 ± 1.5 | 14.9 ± 0.8 | < .001 | 19.5 ± 1.9 |
| 40 μg/kg rFVIIa | 12 | 12.9 ± 0.5 | 26.8 ± 2.3 | 14.7 ± 0.8 | < .001 | 17.9 ± 1.2 |
| 80 μg/kg rFVIIa | 24 | 13.3 ± 0.6 | 30.4 ± 2.1 | 15.0 ± 1.0 | < .001 | 18.0 ± 1.7 |
| INR | ||||||
| Experiment 1 | 11 | 1.1 ± 0.04 | 2.5 ± 0.3 | |||
| Experiment 2 | ||||||
| Placebo | 24 | 1.0 ± 0.1 | 2.5 ± 0.3 | 2.5 ± 0.3 | 2.4 ± 0.3 | |
| 5 μg/kg rFVIIa | 6 | 1.1 ± 0.1 | 2.7 ± 0.3 | 1.5 ± 0.5 | < .001 | 2.1 ± 0.3 |
| 10 μg/kg rFVIIa | 6 | 1.1 ± 0.1 | 2.6 ± 0.2 | 1.3 ± 0.1 | < .001 | 1.8 ± 0.1 |
| 20 μg/kg rFVIIa | 13 | 1.1 ± 0.1 | 2.4 ± 0.2 | 1.2 ± 0.1 | < .001 | 1.7 ± 0.2 |
| 40 μg/kg rFVIIa | 12 | 1.0 ± 0.1 | 2.5 ± 0.3 | 1.2 ± 0.1 | < .001 | 1.5 ± 0.1 |
| 80 μg/kg rFVIIa | 24 | 1.1 ± 0.1 | 2.8 ± 0.2 | 1.2 ± 0.1 | < .001 | 1.5 ± 0.2 |
Based on paired t tests that compared rFVIIa values at B2 with placebo values.