Four-factor prothrombin complex concentrates in paediatric patients - a retrospective case series

Background: Four-factor prothrombin complex concentrates (PCCs) are human plasma-derived products containing coagulation factors II, VII, IX and X as well as proteins C and S. They are licensed in many countries for treatment of bleeding or urgent periprocedural prophylaxis in patients with acquired deficiency of prothrombin complex coagulation factors, typically in the setting of vitamin K antagonist (VKA) usage. Efficacy and safety have been established in the adult population, but there is little information in the literature regarding their use for these indications in the paediatric population. We report on our institution's experience with these products in paediatric patients over a five-year period.

Method: A retrospective case series study was performed, whereby any patient aged 0-16 years who had received PCCs between 2009 and 2013 was identified. Details regarding patient demographics, indications, dose, relevant bloodwork, additional blood products used, adverse effects and general outcomes were obtained through chart and blood bank reviews.

Results: A total of sixteen patients were included in our study, fourteen of whom received PCCs in a perioperative setting. Eleven received product for VKA reversal. Significant improvements in PT INRs were observed in those patients who had timely bloodwork drawn. Five others received product for reasons not related to VKA use. One thrombotic event was detected a day following PCC infusion, but causation is uncertain.

Conclusion: Within study limitations, when used for rapid reversal of VKAs, efficacy and safety of these products in a paediatric population appear to be similar to those reported in adults.