Transfusion Savings in Heart Surgery: Impact of Individual Strategy by Erythropoietin and Metabolic Adjustment (ScvO2)
Condition: Cardiac Surgery; Transfusion; Perioperative Anemia
Study type: Interventional

Summary: 
      Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in
      cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus
      strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be
      developed .The study evaluate an individual blood conservation strategy based on patient
      blood management bundles in cardiac surgery patients: optimisation perioperative hemoglobin
      level by erythropoietin and ferric carboxymaltose (Ferinject) associated with the use of
      ScV02 to guide perioperative erythrocyte transfusion.
    

Detailed description: 
      Preoperative anemia is the most common haematological abnormalities in cardiac surgery
      affecting 20 to 40% of patients and is becoming increasingly prevalent due to an ageing
      population with more chronic diseases.Preoperative anemia is independently associated with
      increased risk of adverse outcome following cardiac surgery but also implies blood
      transfusions which, associated with anemia, increase significantly perioperative cardiac
      morbidity and mortality. Therefore, strategies of blood conservation to optimize anemia and
      to minimize transfusion have been developped in the concept of the Blood Patient Management
      (BPM). To correct anemia, intravenous iron has been shown to be an effective treatment with
      increase hemoglobin (Hb) level in the perioperative period. It is now established that
      intravenous iron, as ferric carboxymaltose (Ferinject) is better tolerated compared to oral
      supplementation with better stimulation of erythropoiesis and,consequently, higher Hb levels.
      Based on promising results in the orthopedic surgery patients, the use of recombinant human
      erythropoietin (EPO) has also been proposed in cardiac surgery. Secondly, because even one
      red blood cells products (RBC) compromises postoperative outcome, guidelines suggest to adopt
      restrictive threshold of Hb levels to decide RBC transfusion. However, beyond the fact that
      RBC transfusion correct Hb level, the final goal of blood transfusion is to improve oxygen
      delivery to hypoxemic tissue. In this respect, the relevance of the use of a Hb threshold to
      guide transfusion have been questioned. Venous oxygen saturation (SvO2) and ScvO2 (central
      oxygen venous saturation), global parameters of tissue oxygenation, in stable hemodynamic and
      respiratory conditions, may be an relevant marker of anemia tolerance. Recently, the
      investigators demonstrated the lack of benefit in terms of ScvO2 increase during erythrocyte
      transfusion if ScvO2 was > 65%.

      In order to reduce exposure to transfusion, the management of anemia with EPO and
      perioperative intravenous FCM associated with the use of ScvO2 could be interesting to both
      improve Hb levels and reduce RBC transfusion.
    

Intervention name(s): EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)
Intervention type(s): Drug
Intervention description(s): EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if
Hb < 13g/dL the day before surgery
Hb ≥ 7g/dL AND ScvO2 > 65% in postoperative ICU stay
Postoperative Transfusion will be guided by ScvO2 values :
if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb < 7g/dL independently of ScVO2 value
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Perioperative Erythropoietin; Perioperative Iron; ScVO2; Patient blood Management; Blood Transfusion