Haemorrhage during and following surgery results in increased morbidity and mortality. Low plasma
fibrinogen levels have been associated with increased blood loss and transfusion requirements.
Fibrinogen supplementation has been shown to reduce
bleeding in coagulopathic patients. This post hoc study evaluated
fibrinogen repletion and pharmacokinetic data from the REPLACE study. One hundred and fifty-two adult patients undergoing elective aortic surgery requiring
cardiopulmonary bypass (CPB) with defined
bleeding of 60-250 g at first 5 min
bleeding mass were included in the phase III trial. Patients were randomized to receive either
fibrinogen concentrate (FCH) or placebo following CPB removal. Plasma
fibrinogen levels and viscoelastic testing parameters (ROTEM-based FIBTEM and EXTEM assays) were measured before, during, and after study treatment administration. A mean dose of 6.3 g FCH was administered in the FCH group, with a median infusion duration of 2 min. Immediately following completion of FCH administration, a rapid increase in plasma
fibrinogen levels to near baseline (median change from baseline -0.10 g/l) was seen in the FCH group but not in the placebo group (median change from baseline -1.29 g/l). FCH administration also caused an immediate increase in FIBTEM maximum clot firmness (MCF) to 23 mm and improvements in EXTEM coagulation time and clot formation time by the end of infusion. There was a strong correlation between the plasma
fibrinogen level and FIBTEM MCF. Treatment with high doses of FCH with a rapid infusion time resulted in immediate recovery to baseline levels of plasma
fibrinogen and viscoelastic testing parameters.