Intra-aortic balloon pump does not influence cerebral hemodynamics and neurological outcomes in high-risk cardiac patients undergoing cardiac surgery: an analysis of the IABCS trial.

BACKGROUND: The intra-aortic balloon pump (IABP) is often used in high-risk patients undergoing cardiac surgery to improve coronary perfusion and decrease afterload. The effects of the IABP on cerebral hemodynamics are unknown. We therefore assessed the effect of the IABP on cerebral hemodynamics and on neurological complications in patients undergoing cardiac surgery who were randomized to receive or not receive preoperative IABP in the 'Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery' (IABCS) trial. METHODS: This is a prospectively planned analysis of the previously published IABCS trial. Patients undergoing elective coronary artery bypass surgery with ventricular ejection fraction ≤ 40% or EuroSCORE ≥ 6 received preoperative IABP (n = 90) or no IABP (n = 91). Cerebral blood flow velocity (CBFV) of the middle cerebral artery through transcranial Doppler and blood pressure through Finometer or intra-arterial line were recorded preoperatively (T1) and 24 h (T2) and 7 days after surgery (T3) in patients with preoperative IABP (n = 34) and without IABP (n = 33). Cerebral autoregulation was assessed by the autoregulation index that was estimated from the CBFV response to a step change in blood pressure derived by transfer function analysis. Delirium, stroke and cognitive decline 6 months after surgery were recorded. RESULTS: There were no differences between the IABP and control patients in the autoregulation index (T1: 5.5 ± 1.9 vs. 5.7 ± 1.7; T2: 4.0 ± 1.9 vs. 4.1 ± 1.6; T3: 5.7 ± 2.0 vs. 5.7 ± 1.6, p = 0.97) or CBFV (T1: 57.3 ± 19.4 vs. 59.3 ± 11.8; T2: 74.0 ± 21.6 vs. 74.7 ± 17.5; T3: 71.1 ± 21.3 vs. 68.1 ± 15.1 cm/s; p = 0.952) at all time points. Groups were not different regarding postoperative rates of delirium (26.5% vs. 24.2%, p = 0.83), stroke (3.0% vs. 2.9%, p = 1.00) or cognitive decline through analysis of the Mini-Mental State Examination (16.7% vs. 40.7%; p = 0.07) and Montreal Cognitive Assessment (79.16% vs. 81.5%; p = 1.00). CONCLUSIONS: The preoperative use of the IABP in high-risk patients undergoing cardiac surgery did not affect cerebral hemodynamics and was not associated with a higher incidence of neurological complications. Trial registration http://www.clinicaltrials.gov (NCT02143544).

Dynamic cerebral autoregulation: A marker of post-operative delirium?

OBJECTIVE: We investigated the potential association of cerebral autoregulation (CA) with postoperative delirium (PD), a common complication of cardiac surgery with cardiopulmonary bypass (CPB). METHODS: In patients undergoing coronary artery bypass graft (CABG) surgery with CPB, cerebral blood flow velocity (CBFV) and blood pressure (BP) were continuously recorded during 5-min preoperatively (T1), after 24 h (T2), and 7 days after procedure (T3). Prospective multivariate logistic regression analysis was performed to determine the independent risk factors of PD. Autoregulation index (ARI) was calculated from the CBFV response to a step change in BP derived by transfer function analysis. RESULTS: In 67 patients, mean age 64.3 ±â€¯9.5 years, CA was depressed at T2 as shown by values of ARI (3.9 ±â€¯1.7), compared to T1 (5.6 ±â€¯1.7) and T3 (5.5 ±â€¯1.8) (p < 0.001). Impaired CA was found in 37 (55%) patients at T2 and in 7 patients (20%) at T3. Lower ARI at T1 and T2 were predictors of PD (p = 0.003). CONCLUSION: Dynamic CA was impaired after CABG surgery with CPB and was a significant independent risk factor of PD. SIGNIFICANCE: Assessment of CA before and after surgery could have considerable potential for early identification of patients at risk of PD, thus reducing poor outcomes and length of stay. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov (NCT02143544, April 30, 2014).

Predictors of major complications after elective abdominal surgery in cancer patients.

BACKGROUND: Patients undergoing abdominal surgery for solid tumours frequently develop major postoperative complications, which negatively affect quality of life, costs of care and survival. Few studies have identified the determinants of perioperative complications in this group. METHODS: We performed a prospective observational study including all patients (age > 18) undergoing abdominal surgery for cancer at a single institution between June 2011 and August 2013. Patients undergoing emergency surgery, palliative procedures, or participating in other studies were excluded. Primary outcome was a composite of 30-day all-cause mortality and infectious, cardiovascular, respiratory, neurologic, renal and surgical complications. Univariate and multiple logistic regression analyses were performed to identify predictive factors for major perioperative adverse events. RESULTS: Of a total 308 included patients, 106 (34.4%) developed a major complication during the 30-day follow-up period. Independent predictors of postoperative major complications were: age (odds ratio [OR] 1.03 [95% CI 1.01-1.06], p = 0.012 per year), ASA (American Society of Anesthesiologists) physical status greater than or equal to 3 (OR 2.61 [95% CI 1.33-5.17], p = 0.003), a preoperative haemoglobin level lower than 12 g/dL (OR 2.13 [95% CI 1.21-4.07], p = 0.014), intraoperative use of colloids (OR 1.89, [95% CI 1.03-4.07], p = 0.047), total amount of intravenous fluids (OR 1.22 [95% CI 0.98-1.59], p = 0.106 per litre), intraoperative blood losses greater than 500 mL (2.07 [95% CI 1.00-4.31], p = 0.043), and hypotension needing vasopressor support (OR 4.68 [95% CI 1.55-27.72], p = 0.004). The model had good discrimination with the area under the ROC curve being 0.80 (95% CI 0.75-0.84, p < 0.001). CONCLUSIONS: Our findings suggest that a perioperative strategy aimed at reducing perioperative complications in cancer surgery should include treatment of preoperative anaemia and an optimal fluid strategy, avoiding fluid overload and intraoperative use of colloids.

Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncologic Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial.

OBJECTIVE: To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. DESIGN: Single center, randomized, double-blind controlled trial. SETTING: Teaching hospital. PATIENTS: Adult cancer patients with septic shock in the first 6 hours of ICU admission. INTERVENTIONS: Patients were randomized to the liberal (hemoglobin threshold, < 9 g/dL) or to the restrictive strategy (hemoglobin threshold, < 7 g/dL) of RBC transfusion during ICU stay. MEASUREMENTS AND MAIN RESULTS: Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). CONCLUSIONS: We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.

Effect of Perioperative Goal-Directed Hemodynamic Resuscitation Therapy on Outcomes Following Cardiac Surgery: A Randomized Clinical Trial and Systematic Review.

OBJECTIVES: To evaluate the effects of goal-directed therapy on outcomes in high-risk patients undergoing cardiac surgery. DESIGN: A prospective randomized controlled trial and an updated metaanalysis of randomized trials published from inception up to May 1, 2015. SETTING: Surgical ICU within a tertiary referral university-affiliated teaching hospital. PATIENTS: One hundred twenty-six high-risk patients undergoing coronary artery bypass surgery or valve repair. INTERVENTIONS: Patients were randomized to a cardiac output-guided hemodynamic therapy algorithm (goal-directed therapy group, n = 62) or to usual care (n = 64). In the goal-directed therapy arm, a cardiac index of greater than 3 L/min/m was targeted with IV fluids, inotropes, and RBC transfusion starting from cardiopulmonary bypass and ending 8 hours after arrival to the ICU. MEASUREMENTS AND MAIN RESULTS: The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. Patients from the goal-directed therapy group received a greater median (interquartile range) volume of IV fluids than the usual care group (1,000 [625-1,500] vs 500 [500-1,000] mL; p < 0.001], with no differences in the administration of either inotropes or RBC transfusions. The primary outcome was reduced in the goal-directed therapy group (27.4% vs 45.3%; p = 0.037). The goal-directed therapy group had a lower occurrence rate of infection (12.9% vs 29.7%; p = 0.002) and low cardiac output syndrome (6.5% vs 26.6%; p = 0.002). We also observed lower ICU cumulative dosage of dobutamine (12 vs 19 mg/kg; p = 0.003) and a shorter ICU (3 [3-4] vs 5 [4-7] d; p < 0.001) and hospital length of stay (9 [8-16] vs 12 [9-22] d; p = 0.049) in the goal-directed therapy compared with the usual care group. There were no differences in 30-day mortality rates (4.8% vs 9.4%, respectively; p = 0.492). The metaanalysis identified six trials and showed that, when compared with standard treatment, goal-directed therapy reduced the overall rate of complications (goal-directed therapy, 47/410 [11%] vs usual care, 92/415 [22%]; odds ratio, 0.40 [95% CI, 0.26-0.63]; p < 0.0001) and decreased the hospital length of stay (mean difference, -5.44 d; 95% CI, -9.28 to -1.60; p = 0.006) with no difference in postoperative mortality: 9 of 410 (2.2%) versus 15 of 415 (3.6%), odds ratio, 0.61 (95% CI, 0.26-1.47), and p = 0.27. CONCLUSIONS: Goal-directed therapy using fluids, inotropes, and blood transfusion reduced 30-day major complications in high-risk patients undergoing cardiac surgery.

Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial.

OBJECTIVES: Acute acquired hypofibrinogenemia in children undergoing cardiac surgery is a major concern because it often results in perioperative bleeding and high rates of allogeneic blood transfusion. Fibrinogen concentrate has been proposed as an alternative to cryoprecipitate (the gold standard therapy), with minimal infectious and immunologic risks. Our objective was to investigate the efficacy and safety of fibrinogen concentrate in children undergoing cardiac surgery. METHODS: In this randomized pilot study, patients were allocated to receive fibrinogen concentrate (60 mg/kg) or cryoprecipitate (10 mL/kg) if bleeding was associated with fibrinogen levels<1 g/dL after cardiopulmonary bypass weaning. The primary outcome was postoperative blood losses during the 48 hours after surgery. RESULTS: A total of 63 patients were included in the study, 30 in the fibrinogen concentrate group and 33 in the cryoprecipitate group. The median 48-hour blood loss was not significantly different between the 2 groups (320 mL [interquartile range, 157-750] vs 410 mL [interquartile range, 215-510], respectively; P=.672). After treatment, plasma fibrinogen concentration increased similarly following administration of both products. There were no differences in allogeneic blood transfusion after intervention treatment. CONCLUSIONS: A large trial comparing fibrinogen concentrate and cryoprecipitate in the management of children with acute acquired hypofibrinogenemia during heart surgery is feasible. The preliminary results of our study showed that the use of fibrinogen concentrate was as efficient and safe as cryoprecipitate in the management of bleeding children undergoing cardiac surgery.

Blood transfusion in cardiac surgery is a risk factor for increased hospital length of stay in adult patients.

BACKGROUND: Allogeneic red blood cell (RBC) transfusion has been proposed as a negative indicator of quality in cardiac surgery. Hospital length of stay (LOS) may be a surrogate of poor outcome in transfused patients. METHODS: Data from 502 patients included in Transfusion Requirements After Cardiac Surgery (TRACS) study were analyzed to assess the relationship between RBC transfusion and hospital LOS in patients undergoing cardiac surgery and enrolled in the TRACS study. RESULTS: According to the status of RBC transfusion, patients were categorized into the following three groups: 1) 199 patients (40%) who did not receive RBC, 2) 241 patients (48%) who received 3 RBC units or fewer (low transfusion requirement group), and 3) 62 patients (12%) who received more than 3 RBC units (high transfusion requirement group). In a multivariable Cox proportional hazards model, the following factors were predictive of a prolonged hospital length of stay: age higher than 65 years, EuroSCORE, valvular surgery, combined procedure, LVEF lower than 40% and RBC transfusion of > 3 units. CONCLUSION: RBC transfusion is an independent risk factor for increased LOS in patients undergoing cardiac surgery. This finding highlights the adequacy of a restrictive transfusion therapy in patients undergoing cardiac surgery. TRIAL REGISTRATION: Clinicaltrials.gov identifier: http://NCT01021631.

High lactate levels are predictors of major complications after cardiac surgery.

OBJECTIVE: Although hyperlactatemia after cardiac surgery is common, the implications of raised levels remain controversial. The aim of this study was to evaluate whether high lactate levels after cardiac surgery are predictors of major complications including mortality. PATIENTS AND METHODS: This was a substudy of TRACS (Transfusion Requirements After Cardiac Surgery), which was designed as a prospective, randomized, controlled trial evaluating the effects of a transfusion strategy on morbidity and mortality. RESULTS: Of the 502 patients enrolled, 52 (10%) had at least 1 major complication. Patients with complications were older, had a higher EuroSCORE, lower left ventricular ejection fraction, lower preoperative hemoglobin, a higher prevalence of renal disease, and received more blood transfusions than the group without complications. Lactate levels were higher in the group with complications at the end of surgery (3.6 mmol/L [2.8-5.1] vs 3.3 mmol/L [2.2-4.8]; P = .018), immediately after intensive care unit (ICU) admission (0 hour) (4.4 mmol/L [3.1-8.4] vs 4 mmol/L [2.6-6.4]; P = .048); 6 hours (4 mmol/L [2.7-5.8] vs 2.6 mmol/L [2-3.6], P < .001), and 12 hours after admission (2.3 mmol/L [1.8-3.2] vs 1.7 mmol/L [1.3-2]; P < .001). In a multivariate model, higher age (odds ratio [OR], 1.048, 95% confidence interval [CI], 1.011-1.086; P = .010), left ventricular ejection fraction (LVEF) lower than 40% (OR, 3.03; 95% CI, 1.200-7.510; P = .019 compared with LVEF of 40%-59%; OR, 3.571; 95% CI, 1.503-8.196; P = .004 compared with LVEF higher than 60%), higher EuroSCORE (OR, 1.138; 95% CI; 1.007-1.285; P = .038), red blood cell transfusion (OR, 1.230; 95% CI, 1.086-1.393; P = .001), and lactate levels 6 hours after ICU admission (OR, 3.28, 95% CI; 1.61-6.69; P = .001) are predictors of major complications. CONCLUSIONS: Hyperlactatemia 6 hours after ICU admission is an independent risk factor for worse outcomes in adult patients after cardiac surgery.

Bronchial injury and pneumothorax after reintubation using an airway exchange catheter.

BACKGROUND AND OBJECTIVES: We report a case of pneumothorax caused by a bronchial perforation during a reintubation using an airway exchange catheter (AEC) in a patient with a head and neck cancer. CASE REPORT: A 53 year old man with oropharynx carcinoma was admitted to ICU for severe pneumonia and severe acute respiratory distress syndrome (ARDS). The patient was recognized as a difficult-to-intubate patient and an endotracheal tube (ETT) was inserted through a bronchoscope. After one week of treatment, it was observed an endotracheal cuff perforation. Exchanging the endotracheal tube was necessary to achieve satisfactory pulmonary ventilation. An AEC Cook 14 was used to perform the reintubation. After reintubation, the patient presented a worsening in oxygen saturation and a chest radiography (CXR) revealed a large pneumothorax. A chest tube was inserted and we observed immediate improvement in oxygen saturation. A repeat CXR confirmed correct positioning of the chest tube and reexpansion of the right lung. A bronchoscopy performed showed a posterior laceration in the right main bronchus. The patient was extubated the following day. After four days, the chest tube was removed. A CXR performed a day after chest tube removal revealed a small right upper pneumothorax, but the patient remained asymptomatic. CONCLUSIONS: Airway exchange catheter is a valuable tool to handle with difficult-to-intubate patients. Although the physicians generally focus their attention in avoid barotrauma - caused by oxygen supplement or jet ventilation through AEC - concern for insertion technique can minimize life threatening complications and increase the safety of AEC.

Lesão brônquica e pneumotórax após reintubação usando um cateter para troca da via aérea / Bronchial injury and pneumothorax after reintubation using an airway exchange catheter / Lesión brónquica y neumotórax posterior a la reintubación usando un catéter para el cambio de la vía aérea

JUSTIFICATIVA E OBJETIVOS: Relatamos um caso de pneumotórax causado por perfuração brônquica durante uma reintubação usando um cateter para troca da via aérea (CTVA) em um paciente com câncer de cabeça e pescoço. RELATO DE CASO: Paciente do sexo masculino, 53 anos, com carcinoma de orofaringe, foi internado na UTI com pneumonia grave e síndrome da angústia respiratória aguda (SARA). O paciente foi identificado como sendo de difícil intubação e uma sonda endotraqueal (SET) foi inserida através de um broncoscópio. Após uma semana de tratamento, observou-se ruptura do manguito endotraqueal. A troca da sonda endotraqueal foi necessária para obter uma ventilação pulmonar satisfatória. Um cateter para troca da via aérea (Cook, tamanho 14) foi usado para realizar a reintubação. Depois da reintubação, o paciente apresentou piora na saturação de oxigênio e uma radiografia revelou um grande pneumotórax. Um dreno torácico foi inserido e uma melhora imediata na saturação de oxigênio foi observada. A repetição da radiografia confirmou o posicionamento correto do dreno torácico e a reexpansão do pulmão direito. A broncoscopia realizada mostrou uma laceração posterior do brônquio principal direito. O paciente foi extubado no dia seguinte. Depois de quatro dias, o dreno torácico foi removido. A radiografia realizada um dia depois da retirada do dreno revelou um pequeno pneumotórax no lobo superior direito, mas o paciente permaneceu assintomático. CONCLUSÕES: O cateter para troca da via aérea é uma ferramenta valiosa para lidar com pacientes difíceis de intubar. Embora os médicos geralmente concentrem sua atenção em evitar um barotrauma causado pelo suplemento de oxigênio ou ventilação a jato através do CTVA, a preocupação com a técnica de inserção pode minimizar as complicações que ameaçam a vida e aumentar a segurança do CTVA.

BACKGROUND AND OBJECTIVES: We report a case of pneumothorax caused by a bronchial perforation during a reintubation using an airway exchange catheter (AEC) in a patient with a head and neck cancer. CASE REPORT: A 53 year old man with oropharynx carcinoma was admitted to ICU for severe pneumonia and severe acute respiratory distress syndrome (ARDS). The patient was recognized as a difficult-to-intubate patient and an endotracheal tube (ETT) was inserted through a bronchoscope. After one week of treatment, it was observed an endotracheal cuff perforation. Exchanging the endotracheal tube was necessary to achieve satisfactory pulmonary ventilation. An AEC Cook 14 was used to perform the reintubation. After reintubation, the patient presented a worsening in oxygen saturation and a chest radiography (CXR) revealed a large pneumothorax. A chest tube was inserted and we observed immediate improvement in oxygen saturation. A repeat CXR confirmed correct positioning of the chest tube and reexpansion of the right lung. A bronchoscopy performed showed a posterior laceration in the right main bronchus. The patient was extubated the following day. After four days, the chest tube was removed. A CXR performed a day after chest tube removal revealed a small right upper pneumothorax, but the patient remained asymptomatic. CONCLUSIONS: Airway exchange catheter is a valuable tool to handle with difficult-to-intubate patients. Although the physicians generally focus their attention in avoid barotrauma - caused by oxygen supplement or jet ventilation through AEC - concern for insertion technique can minimize life threatening complications and increase the safety of AEC.

JUSTIFICATIVA Y OBJETIVOS: Relatamos aquí un caso de neumotórax causado por perforación brónquica durante una reintubación usando un catéter para el cambio de la vía aérea (CTVA) en una paciente con cáncer de cabeza y cuello. RELATO DE CASO: Paciente del sexo masculino, 53 años, con carcinoma de orofaringe, que fue ingresado en la UTI con neumonía grave y el síndrome de la angustia respiratoria aguda (SARA). El paciente fue identificado como siendo de difícil intubación y con un broncoscopio se le insertó una sonda endotraqueal (SET). Después de una semana de tratamiento, vimos una ruptura del manguito endotraqueal. El cambio de la sonda endotraqueal se hizo necesario para obtener una ventilación pulmonar satisfactoria. Un catéter para el cambio de la vía aérea (Cook, tamaño 14) se usó para realizar la reintubación. Después de la reintubación, el paciente tuvo un empeoramiento en la saturación de oxígeno y una radiografía reveló un fuerte neumotórax. Un dreno torácico se insertó observando una mejoría inmediata en la saturación de oxígeno. La repetición de la radiografía confirmó el posicionamiento correcto del dreno torácico y la re-expansión del pulmón derecho. La broncoscopia realizada arrojó una laceración posterior del bronquio principal derecho. El paciente se desentubó al día siguiente. Después de cuatro días, el dreno torácico se retiró. La radiografía realizada un día después de la retirada del dreno reveló un pequeño neumotórax en el lóbulo superior derecho, pero el paciente permaneció asintomático. CONCLUSIONES: El catéter para el cambio de la vía aérea es una herramienta valiosa para lidiar con los pacientes difíciles de intubar. Aunque los médicos generalmente concentren su atención en evitar un barotrauma causado por el suplemento de oxígeno o ventilación a chorro por medio del CTVA, la preocupación con la técnica de inserción puede minimizar las complicaciones que amenazan la vida y aumentar la seguridad del CTVA.

Bronchial injury and pneumothorax after reintubation using an airway exchange catheter.

BACKGROUND AND OBJECTIVES: We report a case of pneumothorax caused by a bronchial perforation during a reintubation using an airway exchange catheter (AEC) in a patient with a head and neck cancer. CASE REPORT: A 53 year old man with oropharynx carcinoma was admitted to ICU for severe pneumonia and severe acute respiratory distress syndrome (ARDS). The patient was recognized as a difficult-to-intubate patient and an endotracheal tube (ETT) was inserted through a bronchoscope. After one week of treatment, it was observed an endotracheal cuff perforation. Exchanging the endotracheal tube was necessary to achieve satisfactory pulmonary ventilation. An AEC Cook 14 was used to perform the reintubation. After reintubation, the patient presented a worsening in oxygen saturation and a chest radiography (CXR) revealed a large pneumothorax. A chest tube was inserted and we observed immediate improvement in oxygen saturation. A repeat CXR confirmed correct positioning of the chest tube and reexpansion of the right lung. A bronchoscopy performed showed a posterior laceration in the right main bronchus. The patient was extubated the following day. After four days, the chest tube was removed. A CXR performed a day after chest tube removal revealed a small right upper pneumothorax, but the patient remained asymptomatic. CONCLUSIONS: Airway exchange catheter is a valuable tool to handle with difficult-to-intubate patients. Although the physicians generally focus their attention in avoid barotrauma--caused by oxygen supplement or jet ventilation through AEC--concern for insertion technique can minimize life threatening complications and increase the safety of AEC.

Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial.

CONTEXT: Perioperative red blood cell transfusion is commonly used to address anemia, an independent risk factor for morbidity and mortality after cardiac operations; however, evidence regarding optimal blood transfusion practice in patients undergoing cardiac surgery is lacking. OBJECTIVE: To define whether a restrictive perioperative red blood cell transfusion strategy is as safe as a liberal strategy in patients undergoing elective cardiac surgery. DESIGN, SETTING, AND PATIENTS: The Transfusion Requirements After Cardiac Surgery (TRACS) study, a prospective, randomized, controlled clinical noninferiority trial conducted between February 2009 and February 2010 in an intensive care unit at a university hospital cardiac surgery referral center in Brazil. Consecutive adult patients (n = 502) who underwent cardiac surgery with cardiopulmonary bypass were eligible; analysis was by intention-to-treat. INTERVENTION: Patients were randomly assigned to a liberal strategy of blood transfusion (to maintain a hematocrit ≥30%) or to a restrictive strategy (hematocrit ≥24%). MAIN OUTCOME MEASURE: Composite end point of 30-day all-cause mortality and severe morbidity (cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration) occurring during the hospital stay. The noninferiority margin was predefined at -8% (ie, 8% minimal clinically important increase in occurrence of the composite end point). RESULTS: Hemoglobin concentrations were maintained at a mean of 10.5 g/dL (95% confidence interval [CI], 10.4-10.6) in the liberal-strategy group and 9.1 g/dL (95% CI, 9.0-9.2) in the restrictive-strategy group (P < .001). A total of 198 of 253 patients (78%) in the liberal-strategy group and 118 of 249 (47%) in the restrictive-strategy group received a blood transfusion (P < .001). Occurrence of the primary end point was similar between groups (10% liberal vs 11% restrictive; between-group difference, 1% [95% CI, -6% to 4%]; P = .85). Independent of transfusion strategy, the number of transfused red blood cell units was an independent risk factor for clinical complications or death at 30 days (hazard ratio for each additional unit transfused, 1.2 [95% CI, 1.1-1.4]; P = .002). CONCLUSION: Among patients undergoing cardiac surgery, the use of a restrictive perioperative transfusion strategy compared with a more liberal strategy resulted in noninferior rates of the combined outcome of 30-day all-cause mortality and severe morbidity. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01021631.