However, clinical efficacy of FXIII
administration to treat acquired FXIII
deficiency in paediatric surgery is
currently based on clinical observation
rather than on evidence-based data. a significantly less volume than plasma
transfusion. Although more clinical data
in children are needed, this approach
seems very likely to permit rapid and
effective targeted management.
Recombinant activated FVII
Management of intractable bleeding has
led to a call for a defined rescue therapy.
Although it is well known that some
prerequisites including normothermia,
undisturbed acid–base status, and
normal calcium levels, as well as sufficient
platelet count and plasma fibrinogen
levels are the mainstay for adequate clot
building, many authors have declared
a special role in improving thrombin
potential to enable cessation of bleeding.
Therefore, administration of recombinant
activated FVII (rFVIIa) has been
advocated, whereby clinical evidence
to support its use are lacking.
Activated rFVII is licensed for the
treatment of patients with haemophilia
A or B with inhibitors, and patients with
congenital FVII deficiency. In Europe,
additional approval was granted for
treatment of Glanzmann’s
thrombasthenia. There are published data
for the off-label treatment using rFVIIa
to stop severe bleeding in children with
bleeding during neurosurgical
procedures 39,40 and cardiac surgery. 41
It has been hypothesised that
administration of rFVIIa for treatment
of severe bleeding in adults may only
be efficacious if critical amounts of
fibrinogen and platelets have been
established. 3 As no clear dose has been
established, sound evidence-based data
are lacking, and the treatment using
rFVIIa increases thromboembolic risk
considerably, a recent Cochrane analysis
has advocated against the use of rFVIIa
outside its licensed indications. 42 References
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