Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery: a Bicentric, Prospective Randomized Study

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Other: SVO2 group / control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVO2 group<br>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. | Other: SVO2 group / control group<br> <br> |
| Active Comparator: control group<br>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. | Other: SVO2 group / control group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 15 dys | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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, | 15 days | 
| stroke | stroke, defined by a computed tomography documentation | 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) | 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, | 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 | 15 days | 
| infectious complications | infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents | 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 | 15 days | 
| lactate Rate |  | 15 days | 
| 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 | 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. | 15 days | 
| Rate of lactate | Rate of lactate | 15 days | 
| central venous O2 saturation (SVO2) | central venous O2 saturation (SVO2) | 15 days | 
| SOFA score (sepsis organ failure assessment) | SOFA score (sepsis organ failure assessment) | 15 days | 
| Rate BNP | Rate BNP | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ScVO2, Post operative red cell transfusion