Table 5.
Reagent | Measure | Hour | Kcentra/ Placebo GMR | Lower 95% CI | Upper 95% CI | p‐value |
---|---|---|---|---|---|---|
PPP low | Peak thrombin generation | 24 | 1.24 | 0.87 | 1.77 | 0.239 |
PPP low | Peak thrombin generation | 48 | 0.88 | 0.62 | 1.26 | 0.476 |
PPP low | Peak thrombin generation | 72 | 0.71 | 0.50 | 1.02 | 0.065 |
PPP | Peak thrombin generation | 24 | 1.24 | 1.08 | 1.42 | 0.003 |
PPP | Peak thrombin generation | 48 | 1.09 | 0.95 | 1.25 | 0.210 |
PPP | Peak thrombin generation | 72 | 1.03 | 0.90 | 1.18 | 0.677 |
PPP low | ETP | 24 | 1.28 | 1.01 | 1.62 | 0.041 |
PPP low | ETP | 48 | 0.96 | 0.76 | 1.22 | 0.740 |
PPP low | ETP | 72 | 0.81 | 0.64 | 1.03 | 0.080 |
PPP | ETP | 24 | 1.32 | 1.23 | 1.41 | <0.001 |
PPP | ETP | 48 | 1.20 | 1.12 | 1.28 | <0.001 |
PPP | ETP | 72 | 1.11 | 1.04 | 1.18 | 0.003 |
PPP low | Lag time | 24 | 1.08 | 0.97 | 1.21 | 0.168 |
PPP low | Lag time | 48 | 1.11 | 0.99 | 1.24 | 0.070 |
PPP low | Lag time | 72 | 1.07 | 0.96 | 1.20 | 0.232 |
PPP | Lag time | 24 | 1.02 | 0.93 | 1.11 | 0.725 |
PPP | Lag time | 48 | 1.06 | 0.98 | 1.16 | 0.150 |
PPP | Lag time | 72 | 1.01 | 0.93 | 1.11 | 0.733 |
PPP low | Time to peak thrombin generation | 24 | 1.06 | 0.98 | 1.15 | 0.117 |
PPP low | Time to peak thrombin generation | 48 | 1.11 | 1.03 | 1.20 | 0.008 |
PPP low | Time to peak thrombin generation | 72 | 1.09 | 1.01 | 1.18 | 0.030 |
PPP | Time to peak thrombin generation | 24 | 1.04 | 0.98 | 1.10 | 0.184 |
PPP | Time to peak thrombin generation | 48 | 1.07 | 1.01 | 1.13 | 0.018 |
PPP | Time to peak thrombin generation | 72 | 1.02 | 0.97 | 1.08 | 0.389 |
PPP low | mVRI | 24 | 1.19 | 0.75 | 1.89 | 0.451 |
PPP low | mVRI | 48 | 0.80 | 0.50 | 1.27 | 0.335 |
PPP low | mVRI | 72 | 0.64 | 0.41 | 1.02 | 0.062 |
PPP | mVRI | 24 | 1.17 | 0.95 | 1.42 | 0.131 |
PPP | mVRI | 48 | 1.03 | 0.84 | 1.25 | 0.790 |
PPP | mVRI | 72 | 1.00 | 0.82 | 1.22 | 0.999 |
CI, confidence interval; ETP, endogenous thrombin potential; GMR, geometric mean ratio; mVRI, mean velocity rate index.