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Treatment with haemostatic agent does not improve stroke survival

Therapy with the haemostatic agent recombinant activated factor VII (rFVIIa) reduces haematoma growth but does not improve survival or reduce severe disability after intracerebral haemorrhage, findings of a phase III trial show.

The results are in contrast with those of an earlier trial, which showed that rFVIIa produced a relative reduction in mortality when administered within four hours of the onset of stroke (PJ, 5 March 2005, p263).

In the current study, researchers randomly assigned 841 patients to receive placebo or rFVIIa (20 or 80µg/kg body weight) within four hours of the onset of stroke. They found that treatment with rFVIIa 80µg/kg resulted in a reduction in the growth of haemorrhage volume.

The mean estimated increase in volume of intracerebral haemorrhage at 24 hours was 26 per cent in the placebo group compared with 18 per cent (P=0.09) and 11 per cent (P<0.001) in the 20µg and 80µg rFVIIa groups, respectively.

However, no significant difference was seen among the three groups in the proportion of patients with poor clinical outcomes (24 per cent in the placebo group, 26 per cent and 29 per cent in the 20µg and 80µg rFVIIa groups, respectively).

The researchers conclude: “Whether the haemostatic effect can translate to a clinical benefit in a subgroup of patients at high risk for active bleeding, either by treatment within an earlier time window or by demonstration of intrahaematomal contrast extravasation after CT angiography, deserves further study.” (New England Journal of Medicine 2008;358:2127.)

Citation: The Pharmaceutical Journal URI: 10014973

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  • Intracerebral haemorrhage: severe disability not reduced by rFVIIa

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