Clinical trial NCT04141631: Transfusion Savings in Heart Surgery: Impact of Individual Strategy by Erythropoietin and Metabolic Adjustment (ScvO2)
Official title: Patient Blood Management in Cardiac Surgery by Erythropoietin, Ferric Carboxymaltose and Metabolic Adjustment (ScvO2): A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Transfusion
Perioperative Anemia
Keywords: Perioperative Erythropoietin
Perioperative Iron
ScVO2
Patient blood Management
Blood Transfusion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Transfusion incidence at hospital discharge
timeFrame: up to Day 28
Secondary outcomes:
measure: ICU transfusion incidence
timeFrame: at ICU discharge or up to Day 28
measure: total of blood units transfused
timeFrame: up to day 28
measure: Hemoglobin level at surgery discharge and Hemoglobin level at 1 month after discharge from hospital
timeFrame: at surgery discharge (or at Day 28) and at 1 month after discharge from hospital
measure: The total duration of mechanical ventilation
timeFrame: at ICU discharge or up to Day 28
measure: length of stay in ICU
timeFrame: up to day 28
measure: Length of hospital stay
timeFrame: at day 28
measure: Incidence of Mortality
timeFrame: at day 28
measure: Incidence of postoperative events in ICU
timeFrame: at day 28
Other outcomes:
Locations:
city: Montpellier
country: France
facility: DEpartement d'anesthésie et réanimation D - Arnaud de Villeneuve
Study officials:
References:
citation: Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G; Surgical and Clinical Outcome Research (SCORE) Group. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):478-85. doi: 10.1016/j.athoracsur.2013.03.015. Epub 2013 May 11.
citation: Plicht B, Lind A, Erbel R. [Infective endocarditis : New ESC guidelines 2015]. Internist (Berl). 2016 Jul;57(7):675-90. doi: 10.1007/s00108-016-0086-y. German.
citation: Alghamdi AA, Davis A, Brister S, Corey P, Logan A. Development and validation of Transfusion Risk Understanding Scoring Tool (TRUST) to stratify cardiac surgery patients according to their blood transfusion needs. Transfusion. 2006 Jul;46(7):1120-9. doi: 10.1111/j.1537-2995.2006.00860.x.
citation: Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.