BACKGROUND: Measurements of activated coagulation time do not correlate with plasma concentration of heparin. This study investigated the effects of a patient-specific method to manage anticoagulation and its reversal in pediatric patients undergoing cardiopulmonary bypass. METHODS:Infants and children were randomly assigned to receive either a standard dose of heparin (300 IU/kg; group C, n = 13) or an individualized dose, calculated by an in vitro heparin dose-response test (group HC, n = 13). Protamine dose was based on a 1 mg/l mg ratio of total administered heparin for patients in group C and of the residual heparin concentration in group HC. RESULTS: Administered heparin was significantly higher and total protamine dose was significantly reduced in the HC group (both p < or = 0.001). There was less thrombin generation (p = 0.02) and fibrinolysis (p = 0.05) in group HC. Blood loss and requirement for transfusion of blood and fresh frozen plasma were also lower in group HC (all p < or =0.05). CONCLUSIONS: An individualized management of anticoagulation and its reversal results in less activation of the coagulation cascade, less fibrinolysis, and reduced blood loss and need for transfusions. Further studies are warranted to better define the clinical impact of these findings.
RCT Entities:
BACKGROUND: Measurements of activated coagulation time do not correlate with plasma concentration of heparin. This study investigated the effects of a patient-specific method to manage anticoagulation and its reversal in pediatric patients undergoing cardiopulmonary bypass. METHODS:Infants and children were randomly assigned to receive either a standard dose of heparin (300 IU/kg; group C, n = 13) or an individualized dose, calculated by an in vitro heparin dose-response test (group HC, n = 13). Protamine dose was based on a 1 mg/l mg ratio of total administered heparin for patients in group C and of the residual heparin concentration in group HC. RESULTS: Administered heparin was significantly higher and total protamine dose was significantly reduced in the HC group (both p < or = 0.001). There was less thrombin generation (p = 0.02) and fibrinolysis (p = 0.05) in group HC. Blood loss and requirement for transfusion of blood and fresh frozen plasma were also lower in group HC (all p < or =0.05). CONCLUSIONS: An individualized management of anticoagulation and its reversal results in less activation of the coagulation cascade, less fibrinolysis, and reduced blood loss and need for transfusions. Further studies are warranted to better define the clinical impact of these findings.
Authors: Colleen E Gruenwald; Cedric Manlhiot; Lynn Crawford-Lean; Celeste Foreman; Leonardo R Brandão; Brian W McCrindle; Helen Holtby; Ross Richards; Helen Moriarty; Glen Van Arsdell; Anthony K Chan Journal: J Extra Corpor Technol Date: 2010-03