Status:
COMPLETED
Fibrinogen Concentrate In Children After Cardiac Surgery
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
CSL Behring
Conditions:
Cardiac Surgical Procedures
Blood Coagulation Disorders
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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 cryoprecipitat...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Previous coagulopathy (clinical history or INR \> 1.5)
- Low platelet count (lower than 100.000)
- Product allergy
- Urgent procedures
- Active infection
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01187225
Start Date
August 1 2010
End Date
November 1 2011
Last Update
January 4 2013
Active Locations (1)
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1
Incor - Heart Institute - University of Sao Paulo
São Paulo, São Paulo, Brazil, 05403000