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A liberal strategy of red blood cell transfusion reduces cardiogenic shock in elderly patients undergoing cardiac surgery
Nakamura RE, Vincent JL, Fukushima JT, Almeida JP, Franco RA, Lee Park C, Osawa EA, Pinto Silva CM, Costa Auler JO Jr, Landoni G, et al
Journal of Thoracic & Cardiovascular Surgery. 2015;150((5)):1314-20.
Abstract
OBJECTIVE The aim of this study was to compare outcomes in patients undergoing cardiac surgery who are aged 60 years or more or less than 60 years after implementation of a restrictive or a liberal transfusion strategy. METHODS This is a substudy of the Transfusion Requirements After Cardiac Surgery (TRACS) randomized controlled trial. In this subgroup analysis, we separated patients into those aged 60 years or more (elderly) and those aged less than 60 years randomized to a restrictive or a liberal strategy of red blood cell transfusion. The primary outcome was a composite defined as a combination of 30-day all-cause mortality and severe morbidity. RESULTS Of the 502 patients included in the Transfusion Requirements After Cardiac Surgery study, 260 (51.8%) were aged 60 years or more and 242 (48.2%) were aged less than 60 years and were included in this study. The primary end point occurred in 11.9% of patients in the liberal strategy group and 16.8% of patients in the restrictive strategy group (P = .254) for those aged 60 years or more and in 6.8% of patients in the liberal strategy group and 5.6% of patients in the restrictive strategy group for those aged less than 60 years (P = .714). However, in the older patients, cardiogenic shock was more frequent in patients in the restrictive transfusion group (12.8% vs 5.2%, P = .031). Thirty-day mortality, acute respiratory distress syndrome, and acute renal injury were similar in the restrictive and liberal transfusion groups in both age groups. CONCLUSIONS Although there was no difference between groups regarding the primary outcome, a restrictive transfusion strategy may result in an increased rate of cardiogenic shock in elderly patients undergoing cardiac surgery compared with a more liberal strategy. Cardiovascular risk of anemia may be more harmful than the risk of blood transfusion in older patients.Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
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Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: A randomized pilot trial
Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA
Journal of Thoracic & Cardiovascular Surgery. 2014;148((4):):1647-55.
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Abstract
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. Copyright 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Clinical Commentary
Dr Simon Stanworth - NHS Blood & Transplant, Oxford, UK
What is known?
There are several different sources of fibrinogen for use in patients with major bleeding such as trauma or postpartum or surgery. The two main concentrated sources are fibrinogen concentrate or cryoprecipitate. Cryoprecipitate is the standard method of fibrinogen supplementation in UK. The evidence relating to the clinical effectiveness of cryoprecipitate is very limited; with very few randomised controlled trials (RCTs) completed to date. Fibrinogen concentrate (FgC) is increasingly available and a recent Cochrane review evaluating the effectiveness of FgC for patients with bleeding found limited data (six small trials, none in trauma) but reported no effect on overall mortality but did find a reduction in allogeneic transfusion.
What did this paper set out to examine?
Pilot trials are needed to inform the design of larger definitive trials which can answer fundamental questions about effectiveness of fibrinogen supplementation in patients with major bleeding. This study describes a pilot study of fibrinogen concentrate or cryoprecipitate to reduce bleeding in children undergoing cardiac surgery. Patients younger than 7 years and admitted for elective cardiac surgery and cardio-pulmonary bypass were screened and eligible for randomisation to receive fibrinogen concentrate (60mg/kg) or cryoprecipitate (10ml/kg) if they developed diffuse bleeding at wound surfaces and a fibrinogen concentration < 1g/L/.
What did they show?
A total of 63 patients were included in the pilot, 30 received fibrinogen concentrate and 33 cryoprecipitate. There were no differences in post-operative blood losses (primary outcome), and the median 48 hour blood loss was not significantly different between the two groups. Rises in plasma fibrinogen concentration were similar between the two groups, and there were no significant differences between the groups for adverse events and a range of other clinical outcomes.
What are the implications for practice and for future work?
In addition to documenting feasibility of recruitment, the pilot study supports the need for larger trials, not just to understand how different sources of fibrinogen should be used, but also to evaluate comparative differences between products. Cryoprecipitate is a pooled blood component) that has a variable, but high Fg concentration (15-20 g/L), but also contains other plasma proteins (FVIII, FXIII, von Willebrand’s factor and fibronectin) which may confer additional haemostatic benefits.
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Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial
Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, et al
JAMA : the Journal of the American Medical Association. 2010;304((14):):1559-67.
Abstract
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.
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Does aprotinin influence the inflammatory response to cardiopulmonary bypass in patients?
Schmartz D, Tabardel Y, Preiser JC, Barvais L, d'Hollander A, Duchateau J, Vincent JL
The Journal of Thoracic and Cardiovascular Surgery. 2003;125((1):):184-90.
Abstract
OBJECTIVES Aprotinin has been shown to have anti-inflammatory properties, but its effects on the inflammatory reaction to cardiopulmonary bypass remain controversial. This prospective, randomized, double-blind study evaluated the influence of aprotinin on various blood markers of inflammation during and after cardiopulmonary bypass. METHODS Sixty male patients underwent coronary artery bypass grafting. The patients were randomized into 3 groups: a placebo group, a second group receiving 2,000,000 KIU of aprotinin followed by an infusion of 500,000 KIU/h and 2,000,000 KIU in the pump prime, and a third group receiving half this dosage. Measurements of tumor necrosis factor, interleukin 6, interleukin 8, interleukin 10, endotoxin, histamine, complement factors, prekallikrein, and prostaglandin D(2) were obtained at baseline, 30 minutes after study drug loading, 10 minutes after the beginning of cardiopulmonary bypass, before the end of bypass, 4 hours after bypass, and on the first and second postoperative days. RESULTS Aprotinin had no significant effect on any of these parameters. As expected, aprotinin reduced early blood loss in both treated groups. CONCLUSIONS These results indicate that aprotinin at doses currently used to reduce blood loss has no significant influence on the systemic inflammatory response during moderate hypothermic cardiopulmonary bypass in human subjects, as assessed by the mediators measured in this study.