Cardiac Surgery, Cardiopulmonary Bypass
Conditions
Keywords
Blood transfusion, Cardiac surgery
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.
Interventions
OTHERAdjusted Transfusion
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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Patients won't be aware of the assignment group
Intervention model description
Multi-center, single-blinded, and randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC transfusion incidence | During cardiac surgery and postoperative ICU stay up to postoperative day 5 | Proportion of RBC transfused patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RBC units transfused during surgery | During cardiac surgery | Number of RBC units transfused during surgery |
| RBC transfusion incidence during postoperative ICU stay | During postoperative ICU stay | Proportions of patients transfused with RBC during postoperative ICU stay |
| RBC units transfused during postoperative ICU stay | During postoperative ICU stay | Number of RBC units transfused during postoperative stay in ICU |
| RBC transfusion incidence at hospital discharge or day 28 | From cadiac surgery to hospital discharge or day 28 | Proportions of patients transfused with RBC at hospital discharge or day 28 |
| RBC units transfused at hospital discharge or day 28 | From cardiac surgery to hospital discharge or day 28 | Number of RBC units transfused at hospital discharge or day 28 |
| Postoperative septic complications | From cardiac surgery to hospital discharge or day 28 | Proportion of postoperative septic complications |
| Postoperative ischemic complications | From cardiac surgery to hospital discharge or day 28 | Proportion of postoperative ischemic complications (myocardial infarction, stroke, mesenteric) |
| Postoperative acute kidney injury | From cardiac surgery to hospital discharge or day 28 | Proportion postoperative AKI according to Kdigo stages |
| Postoperative liver dysfuncion | From cardiac surgery to hospital discharge or day 28 | Proportion of postoperative increase in binirubin or plasma hepatic enzymes |
| Postoperative respiratory failure | From cardiac surgery to hospital discharge or day 28 | Proportion of postoperative of Pa/Fi\<200 |
| Postoperative low cardiac output syndrome | From cardiac surgery to hospital discharge or day 28 | Proportion of low cardiac output |
| Postoperative arythmias | From cardiac surgery to hospital discharge or day 28 | Proportion of atrial fibrillation |
| Length of ICU stay | From ICU admission to ICU discharge ofr day 28 | ICU length of stay (number of days) |
| Length of hospital stay | From ICU admission to hospital discharge or day 28 | Hospital length of stay (number of days) |
| Postoperative anemia | From ICU admission to hospital discharge or day 28 | Hemoglobin concentration |
| Death | From cardiac surgery to hospital discharge or day 28 | Proportion of deaths |
| Effect of RBC transfusion on Hb | During cardiac surgery and postoperative ICU stay up to postoperative day 5 | Hb changes after RBC transfusion |
| RBC transfusion incidence during surgery | During cardiac surgery | Proportion of patients transfused with RBC during surgery |
| Effect of RBC transfusion on central SvO2 | During cardiac surgery and postoperative ICU stay up to postoperative day 5 | Central SvO2 changes after RBC transfusion |
Countries
France
Outcome results
None listed