SvO2 Trigger in Transfusion Strategy After Cardiac Surgery
Condition: Undergoing Nonemergent Cardiac Surgery; Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure); Anemia (<9g/dL) Requiring Blood Transfusion; Hemodynamic and Respiratory Stability; Bleeding Graded as Insignificant, Mild, Moderate of Universal Definition of Perioperative Bleeding
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Current international guidelines suggest a restrictive transfusion strategy, setting that Hb
      level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for
      all the patients has been challenged by authors, suggesting a more liberal strategy for
      certain cases. At the moment, there is no other parameter considered accurate enough to be
      taken into consideration for transfusion strategy management.

      This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion
      in order to stratify its indication after cardiac surgery.

      Monocentric, randomised, single blind study (patient not aware of the group assignments)
      Patient inclusion will be made in ICU if the physician decides to perform blood transfusion
      according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).

      Every patient will go through randomization to be placed in one of the two groups of the
      study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2
      (group ScvO2), or the control group.

      Our main objective is to evaluate the impact of a new transfusion strategy founded on
      guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells
      transfusion for anemia early after cardiac surgery.
    

Detailed description: 
      Currently, the rate of transfusion of cardiac surgery patients is approximately 50%. The
      decision to transfuse is based on the hemoglobin (Hb), the transfusion threshold from 7 to 9
      g / dL seems to be reasonable, based on clinical parameters, as well as patient history, as
      the degree of coronary stenosis . Several randomized studies have shown that a restrictive
      transfusion strategy was superior to a liberal strategy.

      ScvO2 is a parameter reflecting the balance between transport O2 and O2 in tissue
      consumption, which Hb is one of the determinants. It requires that a levy on central venous
      used frequently for such patients. ScvO2 could make better account of the actual tolerance of
      anemia that the only value of Hb and the patient's clinical characteristics.

      We therefore hypothesize that ScvO2 can help with the decision of RBC transfusions after
      heart surgery.

      Primary and secondary endpoints Principal: To assess the value of ScvO2 threshold (65%) in
      the restrictive transfusion strategy on the incidence of transfusion after cardiac surgery.

      secondary:

        -  Assess the impact of transfusion strategy based on ScvO2 on the number of transfused
           patients at D28

        -  Assess the impact of transfusion strategy based on ScvO2 on the number of cells
           transfused concentrates.

        -  Assess the impact of transfusion strategy based on ScvO2 on mortality or incidence of
           disease events such as cardiac complications, renal, respiratory or neurological
           dysfunction in the immediate aftermath of surgery.
    

Intervention name(s): Red blood cell tranfusion; ScvO2 measure
Intervention type(s): Other; Other
Intervention description(s): Red blood cell transfusion according to transfusion guidelines.; ScvO2 (oximetry) is measured at the distal lumen of the central venous catheter placed in the superior vena cava. Transfusion is performed if ScvO2 is inferior or equal to 65%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Cardiac surgery; Blood transfusion; ScvO2