Fibrinogen Concentrate In Children Cardiac Surgery 2

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Filomena R B G Galas

Criteria

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