Cardiac Surgery
Conditions
Keywords
ScVO2, Post operative red cell transfusion
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.
Interventions
OTHERSVO2 group / control group
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patient ≥ 18 years 2. programmed cardiac surgery 3. Central venous catheter placed in territory SVC 4. Affiliation to a social security system 5. Hemoglobin \<9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)
Exclusion criteria
1. Patient minor or under court protection 2. Pregnant or lactating women 3. 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) 4. Installation of an external or internal circulatory support 5. emergency surgery (\<24 hours from admission) 6. Complex Aortic Surgery 7. Sepsis 8. Patient Refusal of transfusion (religious belief) 9. Patient under guardianship 10. Renal failure with dialysis treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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, |
| stroke | 15 days | stroke, defined by a computed tomography documentation |
| 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) |
| 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, |
| 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 |
| infectious complications | 15 days | infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents |
| 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 |
| 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 |
| central venous O2 saturation (SVO2) | 15 days | — |
| SOFA score (sepsis organ failure assessment) | 15 days | — |
| BNP Rate | 15 days | — |
| Death | 15 days | — |
| 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. |
| Rate of lactate | 15 days | Rate of lactate |
| Rate BNP | 15 days | Rate BNP |
| lactate Rate | 15 days | — |
Countries
France
Outcome results
None listed