A Phase 2 interventional study of Fibrinogen concentrate and Cryoprecipitate in Cardiac Surgical Procedures, Blood Coagulation Disorders and Fibrinogen, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2013-01-04.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
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.
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.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 63 is above the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
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Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: Fibrinogen concentrate
Drug: Cryoprecipitate
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
Also known as: Haemocompletan
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
Number of patients receiving any allogeneic blood products
Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge.
Time frame: From ICU admission until hospital discharge
Length of ICU stay
Length of ICU stay - days since arrival at ICU until discharge
Time frame: Up to ICU discharge
Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke
Clinical complications since intraoperative until hospital discharge
Time frame: Up to hospital discharge
Mechanical ventilation free-days
Number of days without mechanical ventilation during ICU stay
Time frame: Up to ICU discharge
Length of hospital stay
Number of days since arrival at ICU until hospital discharge
Time frame: Up to hospital discharge
Vasopressors free-days
Number of days without vasopressors during ICU stay
Time frame: Up to ICU discharge
intraoperative transfusion
intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))
Time frame: intraoperative period
postoperative blood losses
postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission
Time frame: from ICU admission until hospital discharge
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo