Overview

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