rFVIIa Doses Required for the 24 Bleeding Episodes and One Surgical Procedure
| Bleeding Site . | Severity* . | Bleeding Episodes (n) . | No. Doses rFVIIa to Stop Bleeding . | Maintenance rFVIIa Doses After Cessation of Bleeding . | ||||
|---|---|---|---|---|---|---|---|---|
| Mean . | Median . | Range . | Mean . | Median . | Range . | |||
| Nose | Severe | 8 | 3.9 | 2.5 | 1-11 | 3.3 | 2.5 | 1-7 |
| Mild | 5 | 3.8 | 2 | 1-11 | 0.8 | 0 | 0-3 | |
| Oropharynx | Severe | 2 | 3.5 | 3.5 | 3 + 4,† 4‡ | — | — | 1‡ |
| Mild | 5 | 1 | 1 | — | 0.8 | 0 | 0-3 | |
| Hematoma | Mild | 1 | — | — | 1 | — | — | 2 |
| GI (patient 1) | Severe | 1 | — | — | 2 | — | — | 4 |
| GI (patient 2) | Severe | 1 | — | — | 3 + 62-153 | — | — | — |
| GI (patient 3) | Severe | 1 | — | — | 252-155 | — | — | 7 |
| Surgery | — | 1 | — | — | 12-153 | — | — | 122-154 |
| Bleeding Site . | Severity* . | Bleeding Episodes (n) . | No. Doses rFVIIa to Stop Bleeding . | Maintenance rFVIIa Doses After Cessation of Bleeding . | ||||
|---|---|---|---|---|---|---|---|---|
| Mean . | Median . | Range . | Mean . | Median . | Range . | |||
| Nose | Severe | 8 | 3.9 | 2.5 | 1-11 | 3.3 | 2.5 | 1-7 |
| Mild | 5 | 3.8 | 2 | 1-11 | 0.8 | 0 | 0-3 | |
| Oropharynx | Severe | 2 | 3.5 | 3.5 | 3 + 4,† 4‡ | — | — | 1‡ |
| Mild | 5 | 1 | 1 | — | 0.8 | 0 | 0-3 | |
| Hematoma | Mild | 1 | — | — | 1 | — | — | 2 |
| GI (patient 1) | Severe | 1 | — | — | 2 | — | — | 4 |
| GI (patient 2) | Severe | 1 | — | — | 3 + 62-153 | — | — | — |
| GI (patient 3) | Severe | 1 | — | — | 252-155 | — | — | 7 |
| Surgery | — | 1 | — | — | 12-153 | — | — | 122-154 |
Severe: decrease in hemoglobin by 20 g/L or more within the 4 days preceding the start of rFVIIa, or compression of a vital organ.
Lip/frenulum bleed stopped after 3 doses; rebled when wound reopened 63 hours later, requiring 4 additional doses.
As a result, in this category of severe oropharyngeal bleeds, only the episode that required 4 doses to stop had a maintanence dose of 1.
Bleeding stopped after 3 doses; rebled 36 hours later, requiring 6 additional doses.
Platelet transfusion used between the 24th and 25th dose with prompt cessation of bleeding.
One rFVIIa dose just before surgery (bilateral herniorrhaphy) and 12 doses over the next 24 hours.