Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
160
CHU Amiens Picardie
Amiens, France
Caen
Caen, France
Number of patients transfused
Number of patients transfused at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group
Time frame: 15 dys
acute pulmonary edema due to the overload
acute pulmonary edema due to overload or TACO, defined as acute pulmonary edema overload confirmed by clinical examination and echocardiography and leading to medical treatment
Time frame: 15 days
lesional pulmonary edema or TRALI,
lesional pulmonary edema or TRALIassociating acute respiratory distress within 6 hours of transfusion, bilateral infiltrates on chest radiograph, but without respiratory or elevated left ventricular load conditions precedent to echocardiography, and possibly confirmed by tests biological HLA
Time frame: 6 h
myocardial infarction
myocardial infarction, defined by elevated serum troponin dosing greater than 10 times the 99th percentile associated with electrocardioscopic changes (appearance of new Q waves or left bundle branch block), ultrasound (appearance of segmental disorder myocardial kinetics) or angiographic (occlusion of a coronary artery or bypass surgery), as defined by the European society of cardiology in 2012,
Time frame: 15 days
stroke
stroke, defined by a computed tomography documentation
Time frame: 15 days
acute renal failure,
acute renal failure, defined as an increase of at least 50% and / or 26.5 micromol / l of postoperative serum creatinine with respect to the preoperative baseline value and / or urine output less than 0.5 mL / kg / hr about 6 hours (definition of the international society of nephrology KDIGO)
Time frame: 15 days
immunological complications including allo-immunization
immunological complications including allo-immunization, immunological incompatibility and hemolytic accidents involving clinical symptoms (chills, fever, back pain), increased serum bilirubin, decreased the haptoglobinemy the positivization direct antiglobulin test ( DAT), or even looking for irregular antibodies as well as disseminated intravascular coagulation, renal failure, anuria or death in case of conflict in the ABO system,
Time frame: 15 days
allergic complications including anaphylactic shock
allergic complications including anaphylactic shock involving care in intensive care with intravenous injection of adrenaline, vis-à-vis precautions subsequent transfusions and biological investigations and immediate allergy and distance
Time frame: 15 days
infectious complications
infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents
Time frame: 15 days
metabolic complications including febrile non-haemolytic reactions
metabolic complications including febrile non-haemolytic reactions, haemosiderosis and massive transfusion syndrome with hypocalcemia, acid-base imbalance, hyperkalemia, hemostasis disorders and hypothermia
Time frame: 15 days
lactate Rate
Time frame: 15 days
central venous O2 saturation (SVO2)
Time frame: 15 days
SOFA score (sepsis organ failure assessment)
Time frame: 15 days
BNP Rate
Time frame: 15 days
Death
Time frame: 15 days
Cost reduction of transfusion
Cost reduction of transfusion support by reducing the number of PRBC transfusions, including costs related to medical and nursing time, biological examinations pre and post-transfusion, and packed red blood cells.
Time frame: 15 days
Rate of lactate
Rate of lactate
Time frame: 15 days
central venous O2 saturation (SVO2)
central venous O2 saturation (SVO2)
Time frame: 15 days
SOFA score (sepsis organ failure assessment)
SOFA score (sepsis organ failure assessment)
Time frame: 15 days
Rate BNP
Rate BNP
Time frame: 15 days
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