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

• Status: Terminated
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Donato
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• newborns and infants with weight lower than 10 kg undergoing cardiac surgery with extracorporeal circulation:

• informed consent signed by both parents or legal guardian.

Exclusion Criteria:

• emergency surgery;

• known congenital coagulopathy or suspected based on anamnesis;

• participation to other clinical trials;

• known hypersensitivity to components and excipients of FFP , prothrombin complex concentrate or fibrinogen concentrate.