NCT01187225

Fibrinogen Concentrate In Children After Cardiac Surgery

Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 blood cells, fresh frozen plasma, platelet pools, and cryoprecipitate. Furthermore, bleeding may result in re-exploration, which is associated with increased morbidity and mortality.Recent studies have shown that patients and children undergoing cardiac surgery with pump often experience a significant drop in their levels and function of fibrinogen, and it would be in part responsible for the bleeding. In most centre world-wide, it is common practice to treat bleeding in these patients with cryoprecipitate in order to substitute fibrinogen. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump, compared to cryoprecipitate.

Conditions

• Cardiac Surgical Procedures
• Blood Coagulation Disorders
• Fibrinogen
• Cryoprecipitate

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-01-01
• Completion: 2011-11-01
• First posted: 2010-08-24
• Last updated: 2013-01-04

Locations

1 site across 1 country: Brazil