Unexpected posthemorrhagic hydrocephalus in patients treated with rFVIIa.

摘要

One-third of patients with intracerebral hemorrhage (ICH) are dead within 1 month of symptom onset, and only 20% regain functional independence. In a recent Phase KB study, recombinant Factor Vila (rFVIIa) given within 4 hours after the onset of ICH significantly reduced hematoma growth and improved clinical outcomes; this effect is being evaluated in a Phase HI trial. Enthusiasm for the use of rFVIIa is tempered by safety concerns". An increased frequency of thromboembolic complications, notably arterial ischemic events, among patients with ICH treated with rFVIIa has been observed. We report our open-label experience with rFVIIa used within an institution-approved protocol and the occurrence of posthemorrhagic hydrocephalus as an unexpected complication.rFVIIa was administered at a dose of 40 ug/kg body weight to nine patients with ICH diagnosed by CT scan within 3 hours from symptom onset. The inclusion and exclusion criteria for administration of rFVIIa were similar to that of the Phase IIB trial of rFVIIa, and patients were treated after the completion of the Phase IIB trial. Demographic, clinical, and radiologic data were reviewed. Hydrocephalus was defined radiographically on the follow-up CT scan as enlargement of temporal horns with or without ballooning of frontal/occipital horns of the lateral ventricle and third ventricle compared with baseline scans.