Fibrinogen Concentrate In Children After Cardiac Surgery

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac surgery with pump.

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

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: CSL Behring

Criteria

Inclusion Criteria:

• Cardiac surgery with pump

• Age until 18 years

• Written informed consent

• Clinically important bleeding in intraoperative

• Fibrinogen lower than 1 g/L or TEG < 7 mm

Exclusion Criteria:

• Previous coagulopathy (clinical history or INR > 1.5)

• Low platelet count (lower than 100.000)

• Product allergy

• Urgent procedures

• Active infection