Fibrinogen Concentrate In Children After Cardiac Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

January 31, 2011

Study Completion Date

November 30, 2011

Conditions
Cardiac Surgical ProceduresBlood Coagulation DisordersFibrinogenCryoprecipitate
Interventions
DRUG

Fibrinogen concentrate

In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive fibrinogen concentrate (60 mg/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm

DRUG

Cryoprecipitate

In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive cryoprecipiate (10 ml/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm

Trial Locations (1)

05403000

Incor - Heart Institute - University of Sao Paulo, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CSL Behring

INDUSTRY

lead

University of Sao Paulo

OTHER