Comparison of the effect of fibrinogen concentrate with fresh frozen plasma (FFP) in management of hypofibrinogenemic bleeding after congenital cardiac surgeries: A clinical trial study*

BACKGROUND: Hypofibrinogenemia is an independent factor of excessive bleeding after congenital cardiac surgeries. Fresh frozen plasma (FFP) and fibrinogen concentrate are examples of recommended products for management of hypofibrinogenemic bleedings. Unfortunately, there is no study to compare these treatments in pediatric cardiac surgeries. Therefore, this study aimed to compare the effect of fibrinogen concentrate with FFP on postoperative bleeding and clinical outcome after congenital cardiac surgeries in pediatric population. METHODS: Phis prospective clinical trial study was carried out on 90 consecutive pediatric patients who underwent congenital cardiac surgeries. The eligible pediatrics who met our study criteria, randomly received FFP (10 ml/kg) or fibrinogen concentrate (70 mg/kg) to assess postoperative bleeding and blood-products requirements. RESULTS: Each of FFP and fibrinogen concentrate significantly reduced total chest tube drainage (CTD) at 3, 6, 12, and 24 postoperative hours (P = 0.04). The analysis of time*intervention revealed that our intervention (fibrinogen group) significantly reduced CTD more (P = 0.01). Moreover, fibrinogen group had a significantly higher plasma fibrinogen level in first 24 hours (P = 0.02). CONCLUSION: Nowadays, both of fibrinogen concentrate and FFP product are widely used for management of hypofibrinogenic bleedings after cardiac surgeries. According to our results, we concluded that although the both product had a comparable effect on management of hypofibrinogenemic bleeding in pediatrics undergoing congenital cardiac surgeries, choosing better product depended on general condition of patients such as their body fluid status.