The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
42
Fibrinogen Concentrate is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given Fibrinogen Concentrate at an individually determined dose based on FIBTEM MCF and body weight as follows: (15 \[mm\] - MCF \[mm\]) \* body weight \[kg\] / 140 \[mm\*kg/g\] = gram fibrinogen to be dosed as Fibrinogen Concentrate. Fibrinogen Concentrate is to be infused over 1 to 2 minutes. After Fibrinogen Concentrate infusion, bleeding treatment will follow the predefined, standardized treatment regimen.
0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF). 0.9% saline is to be infused over 1 to 2 minutes. After 0.9% saline infusion, bleeding treatment will follow the predefined, standardized treatment regimen.
Incor - Heart Institute - University of Sao Paulo
São Paulo, Brazil
RECRUITINGThe amount of postoperative bleeding
The amount of blood loss (tube drainage) in the first 6 hours of ICU admission and daily until the seventh day of ICU. Re-exploration is mandatory if the patient presente excessive bleeding not responsive to clinical measures (warming, coagulopathy correction and/or thrombocytopenia correction), associated hemodynamic instability or evidence of cardiac tamponade.
Time frame: Within 7 days after cardiac surgery
The amount and type of blood transfusion
The amount and type of intraoperative blood transfusion within the first 6 hours of ICU admission and daily up to the seventh day of ICU.
Time frame: within 7 days after cardiac surgery
Rate of acute kidney injury
According to pediatric RIFLE, will be measured daily.
Time frame: within 28 days after cardiac surgery
Rate of cardiac complications
Occurrence of arrhythmias, low cardiac output, cardiogenic shock and the need of postoperative ventricular assistance
Time frame: within 28 days after cardiac surgery
Rate of neurological complications
Incidence of stroke
Time frame: within 28 days after cardiac surgery
Rate of infection complications
Infection (surgical wound infection, pneumonia, urinary tract infection and bloodstream infection), sepsis, severe sepsis and septic shock.
Time frame: within 28 days after cardiac surgery
Correlation between clot firmness (FIBTEM) and plasma fibrinogen
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Relationship among the results of FIBTEM-A10 and plasma fibrinogen level will be performed at the same time
Time frame: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Evaluation of the clot firmness before and after the intervention
Evaluation between FIBTEM-A10 that will be measured after the cardiopulmonary bypass (CPB) weaning and after drug intervention
Time frame: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Evaluation of plasma fibrinogen before and after the intervention
Evaluation between the fibrinogen level that will be measured after the cardiopulmonary bypass (CPB) weaning, after drug intervention and in the ICU admission.
Time frame: After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission.
Duration of mechanical ventilation
number of hours in which the patient reiman intubated between the date of surgery and discharge from the ICU
Time frame: within 28 days after cardiac surgery
Length of vasoactive drugs
number of hours in which the patient will use vasoactive drugs between the date of surgery and discharge from the ICU
Time frame: within 28 days after cardiac surgery
Length of ICU stay
number of days between the admission and discharge from the ICU.
Time frame: within 28 days after cardiac surgery
Length of hospital stay
number of days between the date of surgery and hospital discharge.
Time frame: within 28 days after cardiac surgery
Rate of mortality
Death from all causes occurring up to 28 days after surgery.
Time frame: within 28 days after cardiac surgery