[Acute treatment with recombinant factor VII is probably indicated for intracerebral haematoma]

G J E Rinkel1

  • 1Universitair Medisch Centrum Utrecht, afd. Neurologie, Heidelberglaan 100, 3584 CX Utrecht. g.j.e.rinkel@umcutrecht.nl

Specific treatment in the acute phase after cerebral haemorrhage is still not available. Corticosteroids and early surgical evacuation have been proven to be ineffective. In the initial 3 hours after a cerebral haemorrhage, the haematoma volume increases in one-third of all patients. Arresting this enlargement may be an effective strategy to improve outcome. Recombinant activated factor VII (rFVIIa) is used to treat bleeding in patients with haemophilia and has also been reported to reduce bleeding in patients without coagulopathy. In a recently published phase-II trial totalling 399 patients given placebo or one of three doses of rFVIIa, treatment with rFVIIa reduced haematoma volume 24 hours after administration. Treatment with rFVIIa was also superior to placebo for several secondary endpoints, including death, handicap and neurological deficits. However, more thromboembolic complications, including myocardial infarction and ischaemic stroke, occurred in the groups given rFVIIa. A new trial, with death or dependency as the primary outcome, has recently been started. The results are expected early in 2007.

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