Departement d'anesthésie et réanimation D - Arnaud de Villeneuve
Montpellier, 34295, France
NCT Number: NCT05740059
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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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Montpellier, 34295, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During cardiac surgery and postoperative ICU stay up to postoperative day 5
Proportion of RBC transfused patients
Time frame: During cardiac surgery
Proportion of patients transfused with RBC during surgery
Time frame: During cardiac surgery
Number of RBC units transfused during surgery
Time frame: During postoperative ICU stay
Proportions of patients transfused with RBC during postoperative ICU stay
Time frame: During postoperative ICU stay
Number of RBC units transfused during postoperative stay in ICU
Time frame: From cadiac surgery to hospital discharge or day 28
Proportions of patients transfused with RBC 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
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion of postoperative septic complications
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion of postoperative ischemic complications (myocardial infarction, stroke, mesenteric)
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion postoperative AKI according to Kdigo stages
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion of postoperative increase in binirubin or plasma hepatic enzymes
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion of postoperative of Pa/Fi<200
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion of low cardiac output
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion of atrial fibrillation
Time frame: From ICU admission to ICU discharge ofr day 28
ICU length of stay (number of days)
Time frame: From ICU admission to hospital discharge or day 28
Hospital length of stay (number of days)
Time frame: From ICU admission to hospital discharge or day 28
Hemoglobin concentration
Time frame: From cardiac surgery to hospital discharge or day 28
Proportion of deaths
Time frame: During cardiac surgery and postoperative ICU stay up to postoperative day 5
Hb changes after RBC transfusion
Time frame: During cardiac surgery and postoperative ICU stay up to postoperative day 5
Central SvO2 changes after RBC transfusion
University Hospital, Montpellier
Other
Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery: Multicenter, Single-blinded, Randomised Controlled Trial.
Acronym: RETSEACSII
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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