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Currently, rFVIIa is registered for peri-operative prophylaxis and the treatment
of bleeding episodes in hemophilic patients. Recent studies have indicated,
however, that the agent can be used for bleeding disorders associated with
surgical procedures in patients without any known congenital hemostasis or
coagulation defects.
To investigate further, Marco Ranucci and colleagues from IRCCS Policlinico
S. Donato in Milan conducted a search of the BioMedCentral, CENTRAL, PubMed,
and PubMed Central databases for randomized controlled trials on the use
of rFVIIa in patients undergoing major surgery.
In all, seven trials involving a total of 772 patients were included. Of
the participants, 265 were placebo controlled, and 507 underwent treatment
with rFVIIa. Patients receiving active treatment were split into those who
received a low dose of rFVIIa of less than 50 µg/kg and those who received
a high dose of 50 µg/kg or more.
Analysis revealed that rFVIIa treatment was associated with a reduced risk
for receiving allogeneic packed red blood cells, at an odds ratio of 0.29,
the researchers report in the Archives of Surgery.
However, analysis by the two dose categories demonstrated that only patients
given an rFVIIa dose of at least 50 µg/kg experienced a significant
benefit, at an odds ratio of 0.43. No other association with thromboembolic
complications or mortality was recorded.
“We believe that this meta-analysis may offer quantitative information on
the size effects of rFVIIa in the surgical setting: its results confirm that
prophylactic use is significantly but marginally effective and probably burdened
by a high cost-benefit ratio,” the researchers conclude.
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