DEpartement d'anesthésie et réanimation D - Arnaud de Villeneuve
Montpellier, 34295, France
NCT Number: NCT04141631
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Montpellier, 34295, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: up to Day 28
Number of patients transfused of blood units
Time frame: at ICU discharge or up to Day 28
Number of blood units transfused during ICU stay
Time frame: up to day 28
number of blood units administered per patient
Time frame: at surgery discharge (or at Day 28) and at 1 month after discharge from hospital
the last hemoglobin value at surgery discharge and the hemoglobin value at 1 month after discharge from hospital
Time frame: at ICU discharge or up to Day 28
The total duration of mechanical ventilation in ICU
Time frame: up to day 28
numbers of days in ICU
Time frame: at day 28
Length of stay during hospitalization (Between 1 and 28 day)
Time frame: at day 28
Incidence of 28-day mortality
Time frame: at day 28
AKI (KDIGO criteria), Cardiac dysfunction (acute heart failure requiring inotrope or extracorporeal life support (ECLS), arrythmia), vascular dysfunction (norepinephrine support without sepsis), respiratory dysfunction (non invasive ventilation devices, secondary intubation,mechanical ventilation more than 12 hours), septic complications (sepsis/septic shock)
University Hospital, Montpellier
Other
Patient Blood Management in Cardiac Surgery by Erythropoietin, Ferric Carboxymaltose and Metabolic Adjustment (ScvO2): A Randomized Controlled Study
Acronym: BLOOCOST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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