ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery
Status:
Terminated
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac
surgery with extracorporeal circulation postoperative bleeding represents a known
complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding
management is associated, particularly in this kind of patients, to volume overload and a
significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening
the postoperative outcome. In the adult patient FFP employment could be almost completely
canceled by administration of concentrated hemostatic components - the fibrinogen concentrate
and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish
whether an analogous strategy, modified accordingly to pediatric physiology, could be safely
and successfully applied in newborns and infants.