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Association Between Length of Storage of Transfused Packed RBC Units and Outcome of Surgical Critically Ill Adults: A Subgroup Analysis of the Age of Blood Evaluation Randomized Trial
Lehr AR, Hébert P, Fergusson D, Sabri E, Lacroix J
Critical care medicine. 2022
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Editor's Choice
Abstract
OBJECTIVES The Age of Blood Evaluation (ABLE) study reported no clinical benefit in fresher compared with standard delivery RBC units (length of storage: 6.9 ± 4.1 vs 22.0 ± 8.4 d, respectively). Perioperative patients are often anemic, at risk of blood loss, and more exposed to RBC transfusions. We address the question whether fresh RBC units are safer than standard delivery RBC units in perioperative ICU patients. DESIGN Subgroup analysis of surgical nontrauma adults enrolled in the ABLE randomized controlled trial. SETTING ICUs. PATIENTS Three hundred twenty surgical patients among the 2,510 ICU adults recruited in the ABLE study who had a request for a first RBC transfusion in the first week in ICU stay and an anticipated length of mechanical ventilation greater than or equal to 48 hours. We included perioperative patients but excluded elective cardiac surgery and trauma. INTERVENTIONS Surgical participants were allocated to receive either RBC units stored less than or equal to 7 days or standard issue RBC. MEASUREMENTS AND MAIN RESULTS The primary outcome was 90-day all-cause mortality.One hundred seventy-two perioperative patients were allocated to the fresh and 148 to the standard group. Baseline data were similar. The length of storage was 7.2 ± 6.4 in fresh and 20.6 ± 8.4 days in standard group (p < 0.0001). The 90-day mortality was 29.7% and 28.4%, respectively (absolute risk difference: 0.01; 95% CI -0.09 to 0.11; p = 0.803). No significant differences were observed for all secondary outcomes, including 6-month mortality, even after adjustment for age, country, and Acute Physiology and Chronic Health Evaluation score. CONCLUSIONS There was no evidence that fresh red cells improved outcomes as compared to standard issue red cells in critically ill surgical patients, consistent with other patients enrolled in the ABLE trial.
PICO Summary
Population
A subgroup of surgical non-trauma patients enrolled in the Age of Blood Evaluation (ABLE) trial (n= 320).
Intervention
Fresh red blood cell (RBC) units (stored less than or equal to 7 days), (n= 172).
Comparison
Standard issue RBC (n= 148).
Outcome
The primary outcome was 90-day all-cause mortality. Baseline data were similar. The length of storage was 7.2 ± 6.4 in fresh and 20.6 ± 8.4 days in standard group. The 90-day mortality was 29.7% and 28.4%, respectively (absolute risk difference: 0.01; 95% CI: -0.09 to 0.11). No significant differences were observed for all secondary outcomes, including 6-month mortality, even after adjustment for age, country, and Acute Physiology and Chronic Health Evaluation score.
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How outcomes are measured after spontaneous intracerebral hemorrhage: A systematic scoping review
Massicotte S, Lun R, Yogendrakumar V, Dewar B, Chung HS, Konder R, Yim H, Davis A, Fergusson D, Shamy M, et al
PloS one. 2021;16(6):e0253964
Abstract
BACKGROUND AND PURPOSE Recovery after intracerebral haemorrhage (ICH) is often slower than ischemic stroke. Despite this, ICH research often quantifies recovery using the same outcome measures obtained at the same timepoints as ischemic stroke. The primary objective of this scoping review is to map the existing literature to determine when and how outcomes are being measured in prospective studies of recovery after ICH. METHODS We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials and Web of Science from inception to November 2019, for prospective studies that included patients with ICH. Two investigators independently screened the studies and extracted data around timing and type of outcome assessment. RESULTS Among the 9761 manuscripts reviewed, 395 met inclusion criteria, of which 276 were observational studies and 129 were interventional studies that enrolled 66274 patients. Mortality was assessed in 93% of studies. Functional outcomes were assessed in 85% of studies. The most frequently used functional assessment tool was the modified Rankin Scale (mRS) (60%), followed by the National Institute of Health Stroke Severity Scale (22%) and Barthel Index (21%). The most frequent timepoint at which mortality was assessed was 90 days (41%), followed by 180 days (18%) and 365 days (12%), with 2% beyond 1 year. The most frequent timepoint used for assessing mRS was 90 days (62%), followed by 180 days (21%) and 365 days (17%). CONCLUSION While most prospective ICH studies report mortality and functional outcomes only at 90 days, a significant proportion do so at 1 year and beyond. Our results support the feasibility of collecting long-term outcome data to optimally assess recovery in ICH.
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Lack of Cost-Effectiveness of Preoperative Erythropoiesis-Stimulating Agents and/or Iron Therapy in Anaemic, Elective Surgery Patients: A Systematic Review and Updated Analysis
Avau B, Van Remoortel H, Laermans J, Bekkering G, Fergusson D, Georgsen J, Manzini PM, Ozier Y, De Buck E, Compernolle V, et al
PharmacoEconomics. 2021
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Editor's Choice
Abstract
OBJECTIVES For anaemic elective surgery patients, current clinical practice guidelines weakly recommend the routine use of iron, but not erythrocyte-stimulating agents (ESAs), except for short-acting ESAs in major orthopaedic surgery. This recommendation is, however, not based on any cost-effectiveness studies. The aim of this research was to (1) systematically review the literature regarding cost effectiveness of preoperative iron and/or ESAs in anaemic, elective surgery patients and (2) update existing economic evaluations (EEs) with recent data. METHODS Eight databases and registries were searched for EEs and randomized controlled trials (RCTs) reporting cost-effectiveness data on November 11, 2020. Data were extracted, narratively synthesized and critically appraised using the Philips reporting checklist. Pre-existing full EEs were updated with effectiveness data from a recent systematic review and current cost data. Incremental cost-effectiveness ratios were expressed as cost per (quality-adjusted) life-year [(QA)LY] gained. RESULTS Only five studies (4 EEs and 1 RCT) were included, one on intravenous iron and four on ESAs + oral iron. The EE on intravenous iron only had an in-hospital time horizon. Therefore, cost effectiveness of preoperative iron remains uncertain. The three EEs on ESAs had a lifetime time horizon, but reported cost per (QA)LY gained of 20-65 million (GBP or CAD). Updating these analyses with current data confirmed ESAs to have a cost per (QA)LY gained of 3.5-120 million (GBP or CAD). CONCLUSIONS Cost effectiveness of preoperative iron is unproven, whereas routine preoperative ESA therapy cannot be considered cost effective in elective surgery, based on the limited available data. Future guidelines should reflect these findings.
PICO Summary
Population
Elective surgery patients with anaemia (5 studies).
Intervention
Intravenous iron.
Comparison
Erythrocyte-stimulating agents (ESAs) and oral iron.
Outcome
The economic evaluation on intravenous iron only had an in-hospital time horizon. Cost effectiveness of preoperative iron remained uncertain. The three economic evaluations on ESAs had a lifetime time horizon, but reported cost per (QA)LY gained of 20-65 million (GBP or CAD). Updating these analyses with current data confirmed ESAs to have a cost per (QA)LY gained of 3.5-120 million (GBP or CAD).
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Volume-dependent effect of stored red blood cells: A secondary analysis of the Age of Blood Evaluation trial
Mack J, Kahn SR, Tinmouth A, Fergusson D, Hébert PC, Lacroix J
Transfusion. 2020
Abstract
BACKGROUND An increased risk of complications, including death, has been associated with stored red blood cell (RBC) units in observational studies but not in randomized trials. We aimed to evaluate for volume-dependent effects attributable to length of RBC storage in a secondary analysis of the Age of Blood Evaluation (ABLE) trial. STUDY DESIGN AND METHODS In the 2510 critically ill adults from the ABLE trial randomized to receive RBC units stored not more than 7 days or the oldest compatible RBC units, we estimated the hazard ratio (HR) for death by intensive care unit (ICU) and hospital discharge and by days 28, 90, and 180, within subgroups defined by the number of RBC units received. Extended Cox proportional hazards regression was used to model the HR. RESULTS A volume-dependent effect of storage age on survival was present for death by 90 and 180 days, but not earlier endpoints. The HR for death by 90 days was 0.55 (95% confidence interval [CI], 0.11-0.98, fresh vs standard) after transfusion of 6 RBC units but 1.45 (95% CI, 1.06-1.98) after transfusion of 1 RBC unit. CONCLUSION In this exploratory analysis, volume-dependent effects related to RBC storage were documented in the ABLE trial. The harms associated with small volumes of fresh RBC units and large volumes of older RBC units should be further explored.
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Liberal Versus Restrictive Red Blood Cell Transfusion Thresholds in Hematopoietic Cell Transplantation: A Randomized, Open Label, Phase III, Noninferiority Trial
Tay J, Allan DS, Chatelain E, Coyle D, Elemary M, Fulford A, Petrcich W, Ramsay T, Walker I, Xenocostas A, et al
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2020;:Jco1901836
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Editor's Choice
Abstract
PURPOSE Evidence regarding red blood cell (RBC) transfusion practices and their impact on hematopoietic cell transplantation (HCT) outcomes are poorly understood. PATIENTS AND METHODS We performed a noninferiority randomized controlled trial in four different centers that evaluated patients with hematologic malignancies requiring HCT who were randomly assigned to either a restrictive (hemoglobin [Hb] threshold < 70 g/L) or liberal (Hb threshold < 90 g/L) RBC transfusion strategy between day 0 and day 100. The noninferiority margin corresponds to a 12% absolute difference between groups in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) score relative to baseline. The primary outcome was health-related quality of life (HRQOL) measured by FACT-BMT score at day 100. Additional end points were collected: HRQOL by FACT-BMT score at baseline and at days 7, 14, 28, 60, and 100; transplantation-related mortality; length of hospital stay; intensive care unit admissions; acute graft-versus-host disease; Bearman toxicity score; sinusoidal obstruction syndrome; serious infections; WHO Bleeding Scale; transfusion requirements; and reactions to therapy. RESULTS A total of 300 patients were randomly assigned to either restrictive-strategy or liberal-strategy treatment groups between 2011 and 2016 at four Canadian adult HCT centers. After HCT, mean pre-transfusion Hb levels were 70.9 g/L in the restrictive-strategy group and 84.6 g/L in the liberal-strategy group (P < .0001). The number of RBC units transfused was lower in the restrictive-strategy group than in the liberal-strategy group (mean, 2.73 units [standard deviation, 4.81 units] v 5.02 units [standard deviation, 6.13 units]; P = .0004). After adjusting for transfusion type and baseline FACT-BMT score, the restrictive-strategy group had a higher FACT-BMT score at day 100 (difference of 1.6 points; 95% CI, -2.5 to 5.6 points), which was noninferior compared with that of the liberal-strategy group. There were no significant differences in clinical outcomes between the transfusion strategies. CONCLUSION In patients undergoing HCT, the use of a restrictive RBC transfusion strategy threshold of 70 g/L was as effective as a threshold of 90 g/L and resulted in similar HRQOL and HCT outcomes with fewer transfusions.
PICO Summary
Population
Patients with haematologic malignancies requiring haematopoietic cell transplantation (HCT) across four Canadian HCT centres, (n=300).
Intervention
Restrictive red blood cell transfusion (RBC) strategy (haemoglobin [Hb] threshold < 70 g/L), (n= 150).
Comparison
Liberal RBC transfusion strategy (Hb threshold < 90 g/L), (n= 150).
Outcome
After HCT, mean pre-transfusion Hb levels were 70.9 g/L in the restrictive-strategy group and 84.6 g/L in the liberal-strategy group. The number of RBC units transfused was lower in the restrictive-strategy group than in the liberal-strategy group (mean, 2.73 units vs. 5.02 units). After adjusting for transfusion type and baseline Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) score, the restrictive-strategy group had a higher FACT-BMT score at day 100 (difference of 1.6 points), which was non-inferior compared with that of the liberal-strategy group. There were no significant differences in clinical outcomes between the transfusion strategies.
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Effect of age of transfused red blood cells on neurologic outcome following traumatic brain injury (ABLE-tbi Study): a nested study of the Age of Blood Evaluation (ABLE) trial
Ruel-Laliberte J, Lessard Bonaventure P, Fergusson D, Lacroix J, Zarychanski R, Lauzier F, Tinmouth A, Hebert PC, Green R, Griesdale D, et al
Canadian Journal of Anaesthesia. 2019;66(6):696-705
Abstract
BACKGROUND Anemia is common in critically ill patients with traumatic brain injury, and often requires red blood cell transfusion. Studies suggest that prolonged storage causes lesions of the red blood cells, including a decreased ability to carry oxygen. Considering the susceptibility of the brain to hypoxemia, victims of traumatic brain injury may thus be more vulnerable to exposure to older red blood cells. METHODS Our study aimed to ascertain whether the administration of fresh red blood cells (seven days or less) results in a better neurologic outcome compared with standard red blood cells in critically ill patients with traumatic brain injury requiring transfusion. The Age of Blood Evaluation in traumatic brain injury (ABLE-tbi) study was a nested study within the ABLE study (ISRCTN44878718). Our primary outcome was the extended Glasgow Outcome Scale (GOSe) at six months. RESULTS In the ABLE study, 217 subjects suffered a traumatic brain injury: 110 in the fresh group, and 107 in the standard group. In the fresh group, 68 (73.1%) of the patients had an unfavourable neurologic outcome (GOSe <= 4) compared with 60 (64.5%) in the standard group (P = 0.21). Using a sliding dichotomy approach, we observed no overall effect of fresh red blood cells on neurologic outcome (odds ratio [OR], 1.34; 95% confidence interval [CI], 0.72 to 2.50; P = 0.35) but observed differences across prognostic bands with a decreased odds of unfavourable outcome in patients with the best prognosis at baseline (OR, 0.33; 95% CI, 0.11 to 0.96; P = 0.04) but an increased odds in those with intermediate and worst baseline prognosis (OR, 5.88; 95% CI,1.66 to 20.81; P = 0.006; and OR, 1.67; 95% CI, 0.53 to 5.30; P = 0.38, respectively). CONCLUSION Overall, transfusion of fresh red blood cells was not associated with a better neurologic outcome at six months in critically ill patients with traumatic brain injury. Nevertheless, we cannot exclude a differential effect according to the patient baseline prognosis. TRIAL REGISTRATION ABLE study (ISRCTN44878718); registered 22 August, 2008.
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The epidemiology of multicomponent blood transfusion: a systematic review
Perelman I, Khair S, Dermer E, Tinmouth A, Saidenberg E, Fergusson D
Transfusion medicine (Oxford, England). 2019
Abstract
We performed a systematic review to describe the prevalence of multicomponent blood transfusion and, as a secondary objective, to determine patient characteristics and outcomes associated with multicomponent transfusion. There is a lack of literature on the epidemiology of multicomponent transfusion as most studies concentrate on a single blood product and its utilisation. Patient care and blood management can be optimised by better understanding the patients who receive multicomponent transfusions. The databases Medline, EMBASE and the Cochrane Library of Systematic Reviews were searched. Observational cohort and cross-sectional studies of hospital patients reporting on multicomponent transfusion prevalence or on patient characteristics and outcomes associated with multicomponent transfusion were included. A descriptive synthesis of studies was performed. A total of 37 eligible studies were included. It was found that multicomponent transfusion prevalence varied greatly by patient population and by the combination of blood products given in the multicomponent transfusion. Multicomponent-transfused patients included burn, cardiac surgery, liver surgery and transplant, cancer, infectious diseases, trauma and intensive care unit patients. Five studies found associations between multicomponent transfusion and adverse health outcomes; however, these findings are likely confounded by indication. The overall quality of evidence was low given a fair-to-poor individual study quality, inconsistent multicomponent transfusion prevalence estimates and confounding by indication. Further research is needed to better understand the epidemiology of multicomponent transfusion, including studies on multicomponent transfusion in haematological cancer patients and studies looking for patient characteristics that can better predict multicomponent transfusion need.
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Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference
Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, et al
Jama. 2019;321(10):983-997
Abstract
Importance: Blood transfusion is one of the most frequently used therapies worldwide and is associated with benefits, risks, and costs. Objective: To develop a set of evidence-based recommendations for patient blood management (PBM) and for research. Evidence Review: The scientific committee developed 17 Population/Intervention/Comparison/Outcome (PICO) questions for red blood cell (RBC) transfusion in adult patients in 3 areas: preoperative anemia (3 questions), RBC transfusion thresholds (11 questions), and implementation of PBM programs (3 questions). These questions guided the literature search in 4 biomedical databases (MEDLINE, EMBASE, Cochrane Library, Transfusion Evidence Library), searched from inception to January 2018. Meta-analyses were conducted with the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology and the Evidence-to-Decision framework by 3 panels including clinical and scientific experts, nurses, patient representatives, and methodologists, to develop clinical recommendations during a consensus conference in Frankfurt/Main, Germany, in April 2018. Findings: From 17607 literature citations associated with the 17 PICO questions, 145 studies, including 63 randomized clinical trials with 23143 patients and 82 observational studies with more than 4 million patients, were analyzed. For preoperative anemia, 4 clinical and 3 research recommendations were developed, including the strong recommendation to detect and manage anemia sufficiently early before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations were developed, including 2 strong clinical recommendations for critically ill but clinically stable intensive care patients with or without septic shock (recommended threshold for RBC transfusion, hemoglobin concentration <7 g/dL) as well as for patients undergoing cardiac surgery (recommended threshold for RBC transfusion, hemoglobin concentration <7.5 g/dL). For implementation of PBM programs, 2 clinical and 3 research recommendations were developed, including recommendations to implement comprehensive PBM programs and to use electronic decision support systems (both conditional recommendations) to improve appropriate RBC utilization. Conclusions and Relevance: The 2018 PBM International Consensus Conference defined the current status of the PBM evidence base for practice and research purposes and established 10 clinical recommendations and 12 research recommendations for preoperative anemia, RBC transfusion thresholds for adults, and implementation of PBM programs. The relative paucity of strong evidence to answer many of the PICO questions supports the need for additional research and an international consensus for accepted definitions and hemoglobin thresholds, as well as clinically meaningful end points for multicenter trials.
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The Effectiveness of Tranexamic Acid at Reducing Blood Loss and Transfusion Requirement for Women Undergoing Myomectomy: A Systematic Review and Meta-analysis
Fusca L, Perelman I, Fergusson D, Boutet M, Chen I
Journal of Obstetrics and Gynaecology Canada : Jogc = Journal D'obstetrique Et Gynecologie Du Canada : Jogc. 2018
Abstract
BACKGROUND The surgical removal of fibroids can be associated with excessive blood loss requiring transfusion. OBJECTIVE This review sought to determine the effectiveness of tranexamic acid (TA) in reducing perioperative blood loss in women undergoing myomectomy. METHODS Electronic bibliographic databases were searched from inception until June 3, 2017. The review included RCTs of women of reproductive age with uterine fibroids who were undergoing myomectomy and who received TA or a comparator. Two independent reviewers extracted relevant data, and meta-analysis was performed. RESULTS Three studies included women undergoing abdominal myomectomy. TA significantly reduced intraoperative blood loss by a mean difference of 213.1 mL (95% CI -242.4 to -183.7) and postoperative blood loss by a mean difference of 56.3 mL (95% CI -67.8 to -44.8) compared with control arms. However, no significant differences were seen in blood transfusion requirement (relative risk 0.58; 95% CI 0.33-1.00). In one study for women undergoing hysteroscopic myomectomy, TA was not associated with improved outcomes in transfusion requirement and resulted in reduced postoperative hemoglobin levels compared with oxytocin. CONCLUSION Among women undergoing abdominal myomectomy, TA is effective at reducing perioperative blood loss compared with no treatment or placebo. For women undergoing hysteroscopic myomectomy, TA compared with oxytocin is not associated with improved outcomes in transfusion requirement and resulted in reduced postoperative hemoglobin levels.
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The impact of perioperative red blood cell transfusions in patients undergoing liver resection: a systematic review
Bennett S, Baker LK, Martel G, Shorr R, Pawlik TM, Tinmouth A, McIsaac DI, Hebert PC, Karanicolas PJ, McIntyre L, et al
Hpb : the Official Journal of the International Hepato Pancreato Biliary Association. 2017;19((4):):321-330
Abstract
BACKGROUND Liver resection is associated with a high proportion of red blood cell transfusions. There is a proposed association between perioperative transfusions and increased risk of complications and tumor recurrence. This study reviews the evidence of this association in the literature. METHODS The Medline, EMBASE, and Cochrane databases were searched for clinical trials or observational studies of patients undergoing liver resection that compared patients who did and did not receive a perioperative red blood cell transfusion. Outcomes were mortality, complications, and cancer survival. RESULTS Twenty-two studies involving 6832 patients were included. All studies were retrospective, with no clinical trials. No studies were scored as low risk of bias. The overall proportion of patients transfused was 38.3%. After multivariate analysis, 1 of 5 studies demonstrated an association between transfusion and increased mortality; 5 of 6 demonstrated an association between transfusion and increased complications; and 10 of 18 demonstrated an association between transfusion and decreased cancer survival. CONCLUSION This review supports the evidence linking perioperative blood transfusions to negative outcomes. The most convincing association was with post-operative complications, some association with long-term cancer outcomes, and no convincing association with mortality. These findings support the initiation, and further study, of restrictive transfusion protocols.