4. Low‐dose vs high‐dose rFVIIa in people with haemophilia and inhibitors undergoing surgery ‐ Treatment efficacy time assessments (Shapiro 1998).
Time of assessment | Number (%)* of participants with satisfactory haemostasis | ||||
Minor surgery | Major surgery | P for difference^ | |||
35 µg/kg rFVIIa n = 10 |
90 µg/kg rFVIIa n = 8 |
35 µg/kg rFVIIa n = 5 |
90 µg/kg rFVIIa n = 6 |
||
Intra‐operative | 10 (100) | 7 (88) | 5 (100) | 6 (100) | NS |
Hour 0 | 9 (90) | 8 (100) | 5 (100) | 6 (100) | NS |
Hour 8 | 9 (90) | 8 (100) | 4 (80) | 6 (100) | NS |
Hour 24 | 10 (100) | 8 (100) | 4 (80) | 6 (100) | NS |
Hour 48 | 9 (90) | 8 (100) | 3 (60) | 6 (100) | NS |
Day 3 | 8 (80) | 8 (100) | 2 (40) | 6 (100) | 0.014 |
Day 4 | 7 (70) | 8 (100) | 2 (40) | 6 (100) | 0.008 |
Day 5 | 7 (70) | 8 (100) | 2 (40) | 5 (83) | 0.030 |
*rated by the investigators; ^calculated across both surgery categories.
NS: not significant rFVIIa: recombinant activated factor VII