Management and treatment outcomes of the severe BEs in PERSEPT 1 and PERSEPT 2
| Patient (age, y) . | BE type . | Treatment regimen, μg/kg . | Time to treatment∗ . | Time to bleed control . |
|---|---|---|---|---|
| Patient 1 (34) | Traumatic soft tissue/muscle bleed | 225 | 2 hours 35 minutes | 25 minutes |
| Patient 2 (50) | Spontaneous right hip bleed | 225† | 0 minutes | 6.5 hours |
| Patient 3 (31) | Spontaneous renal hemorrhage | 225 | 3 hours | 10 hours |
| Patient 4 (9) | Spontaneous renal hemorrhage | 225 | 1 hour | 93 hours |
| Patient 5 (8) | Traumatic intracranial bleed | 225† | 2 hour 10 minutes | 2 days‡ |
| Patient 6 (1) | Two (2) traumatic intracranial bleeds | 225†, 225† | 61 minutes Not captured | 30.8 hours 2.9 hours |
| Patient 7 (6) | Traumatic left elbow bleed | 225† | 0 minutes | Insufficient response at 33.5 hours |
| Patient (age, y) . | BE type . | Treatment regimen, μg/kg . | Time to treatment∗ . | Time to bleed control . |
|---|---|---|---|---|
| Patient 1 (34) | Traumatic soft tissue/muscle bleed | 225 | 2 hours 35 minutes | 25 minutes |
| Patient 2 (50) | Spontaneous right hip bleed | 225† | 0 minutes | 6.5 hours |
| Patient 3 (31) | Spontaneous renal hemorrhage | 225 | 3 hours | 10 hours |
| Patient 4 (9) | Spontaneous renal hemorrhage | 225 | 1 hour | 93 hours |
| Patient 5 (8) | Traumatic intracranial bleed | 225† | 2 hour 10 minutes | 2 days‡ |
| Patient 6 (1) | Two (2) traumatic intracranial bleeds | 225†, 225† | 61 minutes Not captured | 30.8 hours 2.9 hours |
| Patient 7 (6) | Traumatic left elbow bleed | 225† | 0 minutes | Insufficient response at 33.5 hours |
Elapsed time between BE recognition and initial eptacog beta infusion. Initial treatment that closely followed BE recognition by the patient/caregiver is indicated by “0 minutes”
The severe BE dosing regimen was not followed: eptacog beta amounts and dosing intervals other than those specified by the 225 μg/kg severe BE dosing protocol were used.
The intracranial bleed resolved with sustained treatment. Patient 5 received eptacog beta for 3 days, followed by aPCC for 17 days. CT scans revealed no further active bleeding after 2 days of eptacog beta treatment.