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

Stopped The study encountered unexpected difficulties in enrolling patients due to requirements for the Informed Consent. 60% of our patients comes from abroad with only one accompanying parent. The rules of our EC require both parents to sign the consent.

Conditions

• Bleeding
• Cardiac Defect
• Surgery--Complications
• Fibrinogenopenia; Acquired
• Transfusion-Related Acute Lung Injury
• Transfusion-Associated Circulatory Overload
• Congenital Heart Disease

Interventions

• DRUG: Fibrinogen Concentrate Human
• DRUG: Prothrombin Complex Concentrate
• BIOLOGICAL: Fresh Frozen Plasma

Sponsor

IRCCS Policlinico S. Donato