Clinical Trials Logo

Fibrinogenopenia; Acquired clinical trials

View clinical trials related to Fibrinogenopenia; Acquired.

Filter by:
  • Terminated  
  • Page 1

NCT ID: NCT04434001 Terminated - Clinical trials for Congenital Heart Disease

ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

ZEPLAST-PED
Start date: February 27, 2020
Phase: Phase 2
Study type: Interventional

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.