Comparison of the Coagulation Effect Achieved by OctaplasLG Versus Fresh Frozen Plasma in Pediatric Cardiac Surgical Patients

Abstract

OctaplasLG is indicated for use in patients undergoing cardiac surgery who require replacement of multiple clotting factors. The use of OctaplasLG over single-donor fresh frozen plasma (FFP) may have beneficial effects when considering the transmission of enveloped viruses. Additionally, it has the potential for fewer adverse reactions, reduced disease transmission, and a more homogenous coagulation factor composition. However, its efficacy and safety have not yet been evaluated in the pediatric population. Pediatric patients aged less than 2 years old and less than 10 kg, who underwent complete tetralogy of Fallot repair and received either OctaplasLG or FFP intraoperatively were identified over a 10-year period for this retrospective analysis. A review of case notes, intra-operative, and laboratory data were used to assess intraoperative blood product usage, blood loss, and postoperative coagulopathy. Data were analyzed to assess the efficacy of OctaplasLG in achieving hemostasis when compared to FFP. Results showed clinically better hemostasis postoperatively in OctaplasLG group compared with FFP group and better coagulation results. OctaplasLG was as effective as FFP when used in pediatric patients undergoing cardiac surgery.

Solvent/Detergent-Treated Plasma in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors: An Open-Label, Multicenter, Post-marketing Study

“…Immediately after surgery, INR and aPTT were significantly lower in patients who received octaplas than in those who received FFP, and the proportion of patients who received additional plasma transfusions was significantly higher in the FFP group compared with the octaplas group. Furthermore, the rate of postoperative infections requiring the use of antibiotics was significantly higher in the FFP group compared with the octaplas group, and no transfusion reactions were observed in either group (18). In a secondary analysis of a prospective, observational study that included 443 critically ill children who received plasma transfusions, FFP and SDP were associated with similar reductions in INR (p = 0.80).…”

“…Octaplas was compared with FFP in a retrospective analysis that included 105 pediatric patients aged <2 years who were undergoing tetralogy of Fallot repair (18). Most patients received octaplas and FFP transfusions in the operating room after cardiopulmonary bypass (93.8 and 85.0%, respectively).…”

Acute haemolytic transfusion reaction after transfusion of fresh frozen plasma in a neonate—Preventable by using solvent/detergent‐treated pooled plasma?

“…4 A retrospective study investigated paediatric cardiac surgical patients that were aged below 2 years and less than 10 kg (undergoing complete tetralogy of Fallot repair), that received either FFP or SD plasma (OctaplasLG) during surgery. 7 The study included 105 patients over a 10-year period, of which 5 years of FFP use and 5 years of SD plasma use. The study showed that SD plasma was as effective in achieving haemostasis as FFP.…”

“…The study showed that SD plasma was as effective in achieving haemostasis as FFP. 7 In a recently published phase IV study in which the safety, tolerability and efficacy of SD plasma (Octaplas) was investigated, 50 patients aged <16 years were included, of which 37 were 0-2 years old. 5 No hyperfibrinolytic or thromboembolic events or adverse drug reactions were reported after transfusion of SD plasma.…”

“…The evidence available consists of smaller or observational studies investigating SD plasma in paediatric use. [4][5][6][7][8] Due to this limited evidence, the product information of SD plasma states that experience with use in children is limited. 9 However, it should be noted that highquality large trials for FFP in paediatric or neonatal use are lacking as well, but the main difference is that FFP is not registered as drug, and therefore stricter regulations apply for SD plasma.…”