Fibrinogen Concentrate In Children Cardiac Surgery 2

Profilatic Fibrinogen Concentrate Reduces Postoperative Bleeding in Pediatric Cardiac Surgery With Cardiopulmonary Bypass: Randomized Study

The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.

Cardiac surgery in children may be associated with excessive perioperative bleeding. Perioperative excessive bleeding is associated with need of transfusion with allogeneic blood products such as red blood cells, fresh frozen plasma, platelet pools, and cryoprecipitate. Furthermore, bleeding may result in re-exploration, which is associated with increased morbidity and mortality.Recent studies have shown that patients and children undergoing cardiac surgery with pump often experience a significant drop in their levels and function of fibrinogen, and it would be in part responsible for the bleeding. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.

Inclusion Criteria:

• Cardiac surgery with pump
• Written informed consent
• Age under 28 days of life or RACHS-1 equal or greater than 3 or reoperation with age under 10 years

Exclusion Criteria:

• Coagulopathy (INR > 1.5)
• Low platelet count (lower than 100.000)
• Product or albumin allergy
• Active endocarditis
• Blalock-Taussig
• Heart transplant
• Anemia (hemoglobin < 10 g/dL)
• Impossibility to receive blood transfusion
• Hepatic dysfunction (total bilirubin > 1.5 mg/dL)
• Known or suspected hypersensitivity to fibrinogen concentrate
• Thrombophilia or previous thrombosis
• Participation in another study