Clinical trial NCT05740059: Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery
Official title: Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery: Multicenter, Single-blinded, Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Keywords: Blood transfusion
Cardiac surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, single-blinded, and randomized controlled trial.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: RBC transfusion incidence
timeFrame: During cardiac surgery and postoperative ICU stay up to postoperative day 5
Secondary outcomes:
measure: RBC transfusion incidence during surgery
timeFrame: During cardiac surgery
measure: RBC units transfused during surgery
timeFrame: During cardiac surgery
measure: RBC transfusion incidence during postoperative ICU stay
timeFrame: During postoperative ICU stay
measure: RBC units transfused during postoperative ICU stay
timeFrame: During postoperative ICU stay
measure: RBC transfusion incidence at hospital discharge or day 28
timeFrame: From cadiac surgery to hospital discharge or day 28
measure: RBC units transfused at hospital discharge or day 28
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Postoperative septic complications
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Postoperative ischemic complications
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Postoperative acute kidney injury
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Postoperative liver dysfuncion
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Postoperative respiratory failure
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Postoperative low cardiac output syndrome
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Postoperative arythmias
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Length of ICU stay
timeFrame: From ICU admission to ICU discharge ofr day 28
measure: Length of hospital stay
timeFrame: From ICU admission to hospital discharge or day 28
measure: Postoperative anemia
timeFrame: From ICU admission to hospital discharge or day 28
measure: Death
timeFrame: From cardiac surgery to hospital discharge or day 28
measure: Effect of RBC transfusion on Hb
timeFrame: During cardiac surgery and postoperative ICU stay up to postoperative day 5
measure: Effect of RBC transfusion on central SvO2
timeFrame: During cardiac surgery and postoperative ICU stay up to postoperative day 5
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement d'anesthésie et réanimation D - Arnaud de Villeneuve
Study officials:
References:
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