Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).

. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).

Pediatric HD

Bleeding

Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).

Fibrinogen

Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).

Cryoprecipitate

University of Virginia Health System

Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU

(intraoperatively = cell saver volume in ml; postoperatively = chest drain output in ml)

Comparison between the study groups of the number of RBC units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Comparison between the study groups of the number of platelets units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Comparison between the study groups of the number of plasma units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Comparison between the study groups of the number of additional cryoprecipitate units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7

Comparison between study groups of the incidence of postoperative surgical chest re-exploration in the ICU/OR for excessive bleeding or cardiac tamponade

comparison of percent of patients requiring factor VIIa for bleeding (intraoperatively or postoperatively in the ICU between the study groups

comparison of the incidence of in-hospital mortality between the study groups

comparison of the incidence of postoperative AKI between study groups. AKI will be assessed based on the Acute Kidney Injury Network (AKIN) classification (stages 0-3, with higher stage reflecting worse outcome)

comparison of the incidence of pneumonia, sternal wound infection, mediastinitis, sepsis between study groups

Comparison between study groups of the percent of patients with seizures/stroke that occur after surgery

comparison of the time to extubation from the completion of surgery until extubation in the ICU between the study groups

comparison of the incidence of DVT/PE/shunt thrombosis between the study groups

comparison of the postoperative time period spent in the ICU

comparison between the study groups of the time in the hospital from admission to the ICU postoperatively until discharge from the hospital

comparison between the groups of the incidence of the need for postoperative circulatory support with ECMO

Jacob Raphael

Professor UVA Department of Anesthesiology

University of Virginia

Octapharma

Death, Sudden, Cardiac

HEART ARREST

Shock, Cardiogenic

Arrhythmias, Cardiac

Hemorrhage

Venous Thrombosis

Embolism

Blood Transfusion

Disseminated Intravascular Coagulation

St Vincent's Hospital

Blood Management During ECMO for Cardiac Support

International Observational Study on BLood Management for Mechanical Circulatory Support Using Extracorporeal Membrane Oxygenation (OBLEX)

Fraction of patients not surviving the index hospital admission

Number of days alive and not treated with ECMO during the first 28 days after the start of the treatment

Number of days alive and not treated in ICU during the first 28 days after the start of the treatment

Number of days alive and not treated with mechanical ventilation during the first 28 days after the start of the treatment

cardiac tamponade/ataque epiléptico

Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

Blood Management During ECMO for Cardiac Support

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