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Completed

NCT Number: NCT04141631

Transfusion Savings in Heart Surgery: Impact of Individual Strategy by Erythropoietin and Metabolic Adjustment (ScvO2)

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DEpartement d'anesthésie et réanimation D - Arnaud de Villeneuve

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled Cardiac surgery for more than 24 hours
  • High risk of perioperative transfusion defined by a TRUST Score ≥ 3
  • Veno-Venous catheter in Superior vena cava territory
  • Patient Affiliate or beneficiary of social security
  • Collection on free, informed and written consent

Exclusion criteria

  • EPO and FCM contraindication
  • Patients already treated by EPO at the time of inclusion
  • Non controlled Infectious endocarditis defined by ESC guidelines 2015
  • Patients including in an other research
  • Patients whose physical and/or psychological health is severely impaired and who, according to the investigator, may affect the participant's compliance with the study.
  • Patients deprived from his rights (guardianship or tutelage measure)
  • Patients who refuses to sign the consent
  • pregnant or lactating woman

Treatment and study plan

EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)

Drug

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

Primary outcomes

  1. Transfusion incidence at hospital discharge

    Time frame: up to Day 28

    Number of patients transfused of blood units

Secondary outcomes

  1. ICU transfusion incidence

    Time frame: at ICU discharge or up to Day 28

    Number of blood units transfused during ICU stay

  2. total of blood units transfused

    Time frame: up to day 28

    number of blood units administered per patient

  3. Hemoglobin level at surgery discharge and Hemoglobin level at 1 month after discharge from hospital

    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

  4. The total duration of mechanical ventilation

    Time frame: at ICU discharge or up to Day 28

    The total duration of mechanical ventilation in ICU

  5. length of stay in ICU

    Time frame: up to day 28

    numbers of days in ICU

  6. Length of hospital stay

    Time frame: at day 28

    Length of stay during hospitalization (Between 1 and 28 day)

  7. Incidence of Mortality

    Time frame: at day 28

    Incidence of 28-day mortality

  8. Incidence of postoperative events in ICU

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Patient Blood Management in Cardiac Surgery by Erythropoietin, Ferric Carboxymaltose and Metabolic Adjustment (ScvO2): A Randomized Controlled Study

Acronym: BLOOCOST

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2019
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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