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Clinical Trial Summary

The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.


Clinical Trial 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. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03884725
Study type Interventional
Source Instituto do Coracao
Contact Filomena RG Galas
Phone +551126615232
Email filomenagalas@hotmail.com
Status Recruiting
Phase Phase 4
Start date March 1, 2019
Completion date June 2019

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