Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery (original) (raw)
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Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery
BACKGROUND The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear. METHODS In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or newonset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes. RESULTS The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, −1.11 percentage points; 95% confidence interval [CI], −2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes. CONCLUSIONS In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898.)
The Annals of Thoracic Surgery, 2014
Background. Perioperative red blood cell transfusion is associated with adverse outcomes after cardiac operations. Although restrictive transfusion protocols have been developed, their safety and efficacy are not well demonstrated, and considerable variation in transfusion practice persists. We report our experience with a restrictive transfusion protocol. Methods. We analyzed the outcomes in 409 patients undergoing cardiac operations enrolled in a trial conducted at 30 centers worldwide. Blood products were administered on the basis of a transfusion algorithm applied across all centers, with a restrictive transfusion trigger of hemoglobin less than or equal to 6 g/dL. Transfusion was acceptable but not mandatory for hemoglobin 6 to 8 g/dL. For hemoglobin 8 to 10 g/dL, transfusion was acceptable only with evidence for endorgan ischemia. Results. The patient population was moderately complex, with 20.5% having combined procedures and 29.6% having nonelective operations. The mean EuroSCORE for
Restrictive Transfusion Strategy after Cardiac Surgery
Anesthesiology
Background Recent guidelines on transfusion in cardiac surgery suggest that hemoglobin might not be the only criterion to trigger transfusion. Central venous oxygen saturation (Svo2), which is related to the balance between tissue oxygen delivery and consumption, may help the decision process of transfusion. We designed a randomized study to test whether central Svo2–guided transfusion could reduce transfusion incidence after cardiac surgery. Methods This single center, single-blinded, randomized controlled trial was conducted on adult patients after cardiac surgery in the intensive care unit (ICU) of a tertiary university hospital. Patients were screened preoperatively and were assigned randomly to two study groups (control or Svo2) if they developed anemia (hemoglobin less than 9 g/dl), without active bleeding, during their ICU stay. Patients were transfused at each anemia episode during their ICU stay except the Svo2 patients who were transfused only if the pretransfusion central...
Liberal or Restrictive Transfusion after Cardiac Surgery
New England Journal of Medicine, 2015
BACKGROUND Whether a restrictive threshold for hemoglobin level in red-cell transfusions, as compared with a liberal threshold, reduces postoperative morbidity and health care costs after cardiac surgery is uncertain. METHODS We conducted a multicenter, parallel-group trial in which patients older than 16 years of age who were undergoing nonemergency cardiac surgery were recruited from 17 centers in the United Kingdom. Patients with a postoperative hemoglobin level of less than 9 g per deciliter were randomly assigned to a restrictive transfusion threshold (hemoglobin level <7.5 g per deciliter) or a liberal transfusion threshold (hemoglobin level <9 g per deciliter). The primary outcome was a serious infection (sepsis or wound infection) or an ischemic event (permanent stroke [confirmation on brain imaging and deficit in motor, sensory, or coordination functions], myocardial infarction, infarction of the gut, or acute kidney injury) within 3 months after randomization. Health care costs, excluding the index surgery, were estimated from the day of surgery to 3 months after surgery. RESULTS A total of 2007 patients underwent randomization; 4 participants withdrew, leaving 1000 in the restrictive-threshold group and 1003 in the liberal-threshold group. Transfusion rates after randomization were 53.4% and 92.2% in the two groups, respectively. The primary outcome occurred in 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group (odds ratio, 1.11; 95% confidence interval [CI], 0.91 to 1.34; P = 0.30); there was no indication of heterogeneity according to subgroup. There were more deaths in the restrictive-threshold group than in the liberal-threshold group (4.2% vs. 2.6%; hazard ratio, 1.64; 95% CI, 1.00 to 2.67; P = 0.045). Serious postoperative complications, excluding primary-outcome events, occurred in 35.7% of participants in the restrictive-threshold group and 34.2% of participants in the liberal-threshold group. Total costs did not differ significantly between the groups. CONCLUSIONS A restrictive transfusion threshold after cardiac surgery was not superior to a liberal threshold with respect to morbidity or health care costs.
Effectiveness of a cardiac surgery-specific transfusion protocol
Transfusion, 2014
BACKGROUND: Cardiac surgery is often complicated by excessive bleeding that is commonly treated with blood products. In the year 2009 a transfusion protocol was introduced specifically designed for cardiac surgery procedures. This study aims to evaluate the effect of this protocol on transfusion of blood products and the occurrence of clinical events. STUDY DESIGN AND METHODS: This was a nonrandomized intervention study. The index group was transfused according to a tailor-made transfusion protocol (operation in 2009/2010) and the control group was transfused according to the Dutch national transfusion guideline (operation in 2007/2008). The primary outcome was mean number of units transfused and proportion of patients transfused. Secondary outcomes were in-hospital mortality, myocardial infarction, cerebrovascular accident or transient ischemic attack, renal injury or failure, rethoracotomy, and prolonged mechanical ventilation. RESULTS: The control group comprised 2685 patients and the index group 2534 patients. The tailor-made transfusion protocol resulted in a decrease of patients transfused with red blood cells (RBCs) and fresh-frozen plasma (FFP) during surgery with odds ratio of 0.69 (95% confidence interval [CI], 0.55-0.86) and 0.63 (95% CI, 0.46-0.86), respectively. Fewer myocardial infarctions were observed in the index group with OR of 0.67 (95% CI, 0.47-0.96). CONCLUSION: The cardiac surgery-specific transfusion protocol resulted in fewer patients transfused with RBCs and FFP and a lower incidence of myocardial infarction. This tailor-made protocol has led to a more judicious use of blood products and is a basis for further refinement of coagulation management during cardiac surgery procedures. E xcessive bleeding is one of the most common complications in cardiac surgery. While the majority of patients undergoing elective cardiac surgery will not receive allogenic blood products, a substantial number of patients consume disproportionately high amounts of blood products. 1 Especially prolonged cardiopulmonary bypass (CPB) times, reoperations, urgent surgeries, and complex cardiac surgical procedures are associated with excessive blood loss and attendant transfusion of blood products. 2,3 Preoperative anemia in cardiac surgery patients increases the rate of adverse clinical events such as stroke, myocardial infarction, and death, 4,5 while on the other hand, administration of blood products is also associated with negative outcomes such as early and late mortality, increased risk for infections, prolonged hospital stay, and decrease of long-term quality of life. 6-9 Each unit of red blood cells (RBCs) transfused is associated with incrementally increased risk for adverse outcome. 10-12 Several studies have compared a strict transfusion regimen to a more liberal transfusion regime showing that a strict ABBREVIATIONS: CABG = coronary artery bypass graft; CKMB = myocardial-specific creatine kinase; CPB = cardiopulmonary bypass; CVA = cerebrovascular accident; ICU = intensive care unit; LVEF = left ventricle ejection fraction; TIA = transient ischemic attack.
Journal of Surgical Research, 2010
Background. Blood product transfusion has been known for immunosuppressive effects, and over-transfusion is linked with adverse outcomes. In cardiac surgery, the risk of non-transfusion can be poor postoperative oxygen delivery and hemorrhage. We hypothesized that infectious complications, organ dysfunction, and mortality result after a given threshold of blood product transfusion is exceeded. Methods. Retrospectively, a prospectively maintained institutional database was analyzed from April 1, 2004 through December 31, 2006. All patients undergoing coronary artery bypass and/or valve operations were evaluated for bivariate and multivariate associations of blood-product transfusion with postoperative complications and mortality. Additionally, risk factors associated with transfusion were assessed. Receiver operator characteristic (ROC) curves analyses were employed to determine transfusion thresholds associated with complications. Results. During the study period, 741 patients met inclusion criteria. Fifty-four percent received postoperative blood-product transfusions. Previous cardiac intervention, renal dysfunction, stroke, and immunosuppression were some of the risks associated with transfusion (P < 0.05). Specific complications independently (P < 0.05) associated with total blood product transfusion identified from the multivariate analysis were infectious, neurologic, organ dysfunction, cardiac, and death. From ROC curve analyses, 5.5 units of total blood product transfusion was the inflection point for infectious complications (sensitivity 73%, specificity 64%) and organ dysfunction (sensitivity 73%, specificity 64%). For mortality, the inflection point was a transfusion of 7.5 units of total blood-products (sensitivity 73%, specificity 71%). Conclusion. Bloodless cardiac surgery is associated with a decreased morbidity and mortality. Limiting transfusion is advisable. Transfusion of less than 5.5 units of total blood-products may not have deleterious effects on outcomes.
Journal of the American Society of Nephrology
BackgroundSafely reducing red blood cell transfusions can prevent transfusion-related adverse effects, conserve the blood supply, and reduce health care costs. Both anemia and red blood cell transfusion are independently associated with AKI, but observational data are insufficient to determine whether a restrictive approach to transfusion can be used without increasing AKI risk.MethodsIn a prespecified kidney substudy of a randomized noninferiority trial, we compared a restrictive threshold for red blood cell transfusion (transfuse if hemoglobin<7.5 g/dl, intraoperatively and postoperatively) with a liberal threshold (transfuse if hemoglobin<9.5 g/dl in the operating room or intensive care unit, or if hemoglobin<8.5 g/dl on the nonintensive care ward). We studied 4531 patients undergoing cardiac surgery with cardiopulmonary bypass who had a moderate-to-high risk of perioperative death. The substudy’s primary outcome was AKI, defined as a postoperative increase in serum crea...
Canadian journal of kidney health and disease, 2018
When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients (~4800) undergoi...