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NCT Number: NCT05740059

Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery

The goal of the clinical trial is to evaluate whether a restrictive transfusion strategy adjusted by SvO2 during the perioperative period of cardiac surgery may reduce the incidence of red blood cell transfusion. Adult patients operated on cardiac surgery will be randomly allocated into two groups, one receiving standard restrictive transfusion, the other receiving SvO2 adjusted restrictive transfusion.The proportion of patients transfused will be compared between the 2 groups.

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Key information

Age range

18 year–85 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

Cardiac surgery represents only a small fraction of all surgical procedures, but consumes a significant proportion of the stored red blood cells (RBC), with almost 50% of patients receiving a perioperative transfusion. Since RBC transfusion is associated with an increased risk of morbidity and mortality, blood patient management strategy has been promoted to favour prevention of anaemia, reduction of bleeding and limitation of transfusion. Current guidelines recommend haemoglobin (Hb) threshold as low as 7 g/dL, but still with a wide possible range (7 to 9 g/dl) and suggest that Hb alone may not be the best criteria for triggering transfusion. As Hb is an oxygen carrier, the rationale for RBC transfusion should be to increase tissue oxygen delivery. Central venous oxygen saturation (central SvO2), which is related to the balance between tissue oxygen delivery and consumption, is easily measurable in cardiac surgery. In a previous study, the investigators showed that in anaemic patients having undergone cardiac surgery, restrictive transfusion according to central SvO2 allowed a significant reduction in RBC transfusion incidence in the ICU. The investigators hypothesize that a restrictive transfusion strategy adjusted by SvO2 during all the perioperative period of cardiac surgery may reduce further the incidence of RBC transfusion. Limiting RBC transfusion to patients with a low SvO2 could save unnecessary transfusions, without increasing the anaemia related risk.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged above 18 years and under 85 years
  • Signed informed consent form from the patient or his/her close relative or surrogate (if present) before inclusion or when possible when the patient has been included in an emergency setting
  • Anaemic (Haemoglobin at inclusion ≤ 13 g/dL)
  • Operated on elective, on-pump cardiac surgery for : Coronary artery bypass graft (CABG); Aortic, mitral or tricuspid valve (replacement or repair); Ascending aorta;Left ventricle assistance device (LVAD)
  • Operated on urgent on-pump cardiac surgery for : CABG;Endocarditis;Aortic dissection; Heart transplantation
  • Subjects must be covered by public health insurance

Exclusion criteria

  • Patient with no central venous catheter inserted in the superior vena cava
  • Pregnant or breast feeding patient
  • Subject unable to read or/and write
  • Participation in another interventional clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
  • Medical history of heparin-induced thrombocytopenia contraindicating heparin use during surgery
  • Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care and persons admitted to a health or social establishment for purposes other than research

Treatment and study plan

Adjusted Transfusion

Other

Patients assigned to the SvO2 group will be transfused if Hb concentration is lower than 9 g/dL and central SvO2 ≤ 65%. Transfusion will be repeated whenever Hb concentration is lower than 9 g/dL and central SvO2 ≤ 65% during surgery and in the ICU (until day 5). Central SvO2 will be measured on a blood sample obtained from the distal lumen of the central venous catheter. Oximetry will be used for measurement with a point-of-care of gas analysis.

Primary outcomes

  1. RBC transfusion incidence

    Time frame: During cardiac surgery and postoperative ICU stay up to postoperative day 5

    Proportion of RBC transfused patients

Secondary outcomes

  1. RBC transfusion incidence during surgery

    Time frame: During cardiac surgery

    Proportion of patients transfused with RBC during surgery

  2. RBC units transfused during surgery

    Time frame: During cardiac surgery

    Number of RBC units transfused during surgery

  3. RBC transfusion incidence during postoperative ICU stay

    Time frame: During postoperative ICU stay

    Proportions of patients transfused with RBC during postoperative ICU stay

  4. RBC units transfused during postoperative ICU stay

    Time frame: During postoperative ICU stay

    Number of RBC units transfused during postoperative stay in ICU

  5. RBC transfusion incidence at hospital discharge or day 28

    Time frame: From cadiac surgery to hospital discharge or day 28

    Proportions of patients transfused with RBC at hospital discharge or day 28

  6. RBC units transfused at hospital discharge or day 28

    Time frame: From cardiac surgery to hospital discharge or day 28

    Number of RBC units transfused at hospital discharge or day 28

  7. Postoperative septic complications

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion of postoperative septic complications

  8. Postoperative ischemic complications

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion of postoperative ischemic complications (myocardial infarction, stroke, mesenteric)

  9. Postoperative acute kidney injury

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion postoperative AKI according to Kdigo stages

  10. Postoperative liver dysfuncion

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion of postoperative increase in binirubin or plasma hepatic enzymes

  11. Postoperative respiratory failure

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion of postoperative of Pa/Fi<200

  12. Postoperative low cardiac output syndrome

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion of low cardiac output

  13. Postoperative arythmias

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion of atrial fibrillation

  14. Length of ICU stay

    Time frame: From ICU admission to ICU discharge ofr day 28

    ICU length of stay (number of days)

  15. Length of hospital stay

    Time frame: From ICU admission to hospital discharge or day 28

    Hospital length of stay (number of days)

  16. Postoperative anemia

    Time frame: From ICU admission to hospital discharge or day 28

    Hemoglobin concentration

  17. Death

    Time frame: From cardiac surgery to hospital discharge or day 28

    Proportion of deaths

  18. Effect of RBC transfusion on Hb

    Time frame: During cardiac surgery and postoperative ICU stay up to postoperative day 5

    Hb changes after RBC transfusion

  19. Effect of RBC transfusion on central SvO2

    Time frame: During cardiac surgery and postoperative ICU stay up to postoperative day 5

    Central SvO2 changes after RBC transfusion

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery: Multicenter, Single-blinded, Randomised Controlled Trial.

Acronym: RETSEACSII

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
Jan 16, 2026

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

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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