Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery
- Conditions
- Cardiac Surgery
- Interventions
- Other: SVO2 group / control group
- Registration Number
- NCT02963883
- Lead Sponsor
- Centre Hospitalier Universitaire, Amiens
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Patient ≥ 18 years
- programmed cardiac surgery
- Central venous catheter placed in territory SVC
- Affiliation to a social security system
- Hemoglobin <9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)
- Patient minor or under court protection
- Pregnant or lactating women
- severe acute hemorrhagic syndrome (defined by bleeding rate greater than 1.5 ml / kg / hour for 6 consecutive hours and / or surgical revision within the first 24 postoperative hours)
- Installation of an external or internal circulatory support
- emergency surgery (<24 hours from admission)
- Complex Aortic Surgery
- Sepsis
- Patient Refusal of transfusion (religious belief)
- Patient under guardianship
- Renal failure with dialysis treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group SVO2 group / control group After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells based on the hemoglobin values, as recommended by the National Health Authority for Anesthesiology, Surgery, Emergency (November 2014 ): transfusion threshold of \<9 g / dl for patients with cardiovascular antecedents. SVO2 group SVO2 group / control group After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells by the individual value of ScvO2, whose value must be greater than 70% after elimination of hypovolemia, hypotension or hypoxemia.
- Primary Outcome Measures
Name Time Method Number of patients transfused 15 dys Number of patients transfused at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group
- Secondary Outcome Measures
Name Time Method stroke 15 days stroke, defined by a computed tomography documentation
BNP Rate 15 days Death 15 days Rate BNP 15 days Rate BNP
myocardial infarction 15 days 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,
allergic complications including anaphylactic shock 15 days 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
metabolic complications including febrile non-haemolytic reactions 15 days metabolic complications including febrile non-haemolytic reactions, haemosiderosis and massive transfusion syndrome with hypocalcemia, acid-base imbalance, hyperkalemia, hemostasis disorders and hypothermia
Rate of lactate 15 days Rate of lactate
acute pulmonary edema due to the overload 15 days 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
lesional pulmonary edema or TRALI, 6 h 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
immunological complications including allo-immunization 15 days 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,
lactate Rate 15 days central venous O2 saturation (SVO2) 15 days central venous O2 saturation (SVO2)
SOFA score (sepsis organ failure assessment) 15 days SOFA score (sepsis organ failure assessment)
acute renal failure, 15 days 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)
infectious complications 15 days infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents
Cost reduction of transfusion 15 days 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.
Trial Locations
- Locations (2)
CHU Amiens Picardie
🇫🇷Amiens, France
Caen
🇫🇷Caen, France