The use of recombinant activated factor VII in three patients with central nervous system hemorrhages associated with factor VII deficiency.
BACKGROUND
Recombinant activated factor VII (rFVIIa) is being tested to improve hemostasis in a variety of bleeding disorders. Clinical indications and efficacy are still being evaluated for this product.


METHODS
Over a 17-month period, rFVIIa was used to treat central nervous system hemorrhage in three patients who were found to have isolated FVII deficiency (21%, 40%, 27%). Patient A fell 30 feet, Patient B suffered a motor vehicle accident, and Patient C had a spinal cord hematoma. None of the patients had a history of bleeding diathesis. All three patients received rFVIIa after failing initial treatment with fresh-frozen plasma.


RESULTS
Patient A was treated with 11 doses (initial dose 95 microg/kg; subsequent doses 8-38 microg/kg) over 10 days; Patient B received 13 doses (45-60 microg/kg) over 13 days; and Patient C received 5 doses (12-24 microg/kg) over 4 days. The prothrombin time corrected from 16.2 +/- 1.8 (mean +/- SD) to 11.2 +/- 1.6 seconds after infusion of rFVIIa, but returned to pretreatment level in 14 +/- 4 hours. At the cessation of therapy, all patients showed neurologic improvement. No complications related to the infusion of rFVIIa occurred.


CONCLUSIONS
The use of rFVIIa may be of value both for its general effect on hemostasis, and specifically in the setting where there is a documented reduction in FVII. Doses lower than those used in patients with FVIII inhibitors appear to be effective in the setting of central nervous system hemorrhage.
Huang
Weei-Yuarn
WY
Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA.
Kruskall
Margot S
MS
Bauer
Kenneth A
KA
Uhl
Lynne
L
Shaz
Beth H
BH
D000293:Adolescent; D000328:Adult; D002493:Central Nervous System Diseases; D005168:Factor VII Deficiency / Q000150:complications / Q000188:drug therapy*; D015942:Factor VIIa / Q000008:administration & dosage / Q000627:therapeutic use*; D006407:Hematoma, Epidural, Cranial / Q000188:drug therapy* / Q000601:surgery; D006408:Hematoma, Subdural / Q000188:drug therapy; D006801:Humans; D020198:Intracranial Hemorrhage, Traumatic / Q000188:drug therapy*; D007796:Laminectomy / Q000009:adverse effects; D008297:Male; D011183:Postoperative Complications / Q000188:drug therapy; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D020206:Subarachnoid Hemorrhage, Traumatic / Q000188:drug therapy
D011994:Recombinant Proteins; D015942:Factor VIIa