0
selected
-
1.
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.
-
2.
The ABLE study: a randomized controlled trial on the efficacy of fresh red cell units to improve the outcome of transfused critically ill adults . French
Lacroix J, Hebert PC, Fergusson D, Tinmouth A, Capellier G, Tiberghien P, Bardiaux L, Canadian Critical Care Trials Group
Transfusion Clinique et Biologique. 2015;22((3)):107-11.
Abstract
Red blood cell units are stored up to 42 days post-collection. The standard policy of blood banks is to deliver the oldest units in order to limit blood wastage. Many caregivers believe that giving fresh rather than old units can improve the outcome of their transfused patients. The ABLE study aims to check if the transfusion of red blood cell units stored seven days or less (fresh arm) improve the outcome of transfused critically ill adults compared to patients who received units delivered according to the standard delivery policy (control arm). From March 2009 to May 2014, 1211 patients were allocated to the fresh arm, 1219 to the control arm (length of storage: 6.1+/-4.9 and 22.0+/-8.4 days respectively, P<0.001). The primary outcome measure was 90-day all-cause mortality post-randomisation: there were 448 deaths (37.0%) in the fresh arm and 430 (35.3%) in the control arm (absolute risk difference: 1.7%; 95% confidence interval: -2.1% to 5.5%). In a survival analysis, the risk of death was higher in the fresh arm (hazard ratio: 1.1; 95%CI: 0.9 to 1.2), but the difference was not statistically significant (P=0.38). The same trend against the fresh arm was observed with all but one secondary outcome measures. The conclusion is that the transfusion of red blood cell units stored seven days or less does not improve the outcome of critically ill adults compared to the transfusion of units stored about three weeks (22.0+/-8.4 days). Copyright © 2015 Elsevier Masson SAS. All rights reserved.
-
3.
Fluid resuscitation with 5% albumin versus normal saline in early septic shock: a pilot randomized, controlled trial
McIntyre LA, Fergusson DA, Cook DJ, Rowe BH, Bagshaw SM, Easton D, Emond M, Finfer S, Fox-Robichaud A, Gaudert C, et al
Journal of Critical Care. 2012;27((3):):317.e1-6.
Abstract
PURPOSE Randomized, controlled trials of fluid resuscitation in early septic shock face many logistic challenges. We describe the Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock (PRECISE) pilot trial study design and report feasibility of patient recruitment. MATERIALS AND METHODS Six Canadian academic centers enrolled adult patients with early suspected septic shock from the emergency department and intensive care unit department. Consent was deferred. Using concealed allocation, participants were randomized to either 5% albumin or 0.9% sodium chloride. Blinded fluid resuscitation started immediately and continued for 7 days in the intensive care unit. Target recruitment was established a priori at 2 patients per site per month. RESULTS Fifty-one patients were enrolled; 50 patients received study fluid. We recruited a median of 2.5 patients (interquartile range [IQR], 1.5-3.0) per site per month into the trial. Median age and Acute Physiology and Chronic Health Evaluation II scores were 64.5 (IQR, 55.0-78.0) and 25.0 (IQR, 20.0-29.0), respectively. Most patients (n = 37 [74.0%]) were enrolled from the emergency department for a median of 1.6 hours (IQR, 0.8-3.5 hours) from their first hypotensive event and received a median of 2.4 L (IQR, 1.5-3.0 L) of resuscitation fluid before inclusion. Consent was deferred for 44 patients (89.8%). CONCLUSIONS Patient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial. Copyright 2012 Elsevier Inc. All rights reserved.
-
4.
Red blood cell transfusion threshold in postsurgical pediatric intensive care patients: a randomized clinical trial
Rouette J, Trottier H, Ducruet T, Beaunoyer M, Lacroix J, Tucci M, Canadian Critical Care Trials Group, PALISI Network
Annals of Surgery. 2010;251((3):):421-7.
Abstract
BACKGROUND The optimal transfusion threshold after surgery in children is unknown. We analyzed the general surgery subgroup of the TRIPICU (Transfusion Requirements in Pediatric Intensive Care Units) study to determine the impact of a restrictive versus a liberal transfusion strategy on new or progressive multiple organ dysfunction syndrome (MODS). METHODS The TRIPICU study, a prospective randomized controlled trial conducted in 17 centers, enrolled a total of 648 critically ill children with a hemoglobin equal to or below 9. 5 g/dL within 7 days of pediatric intensive care unit (PICU) admission to receive prestorage leukocyte-reduced red-cell transfusion if their hemoglobin dropped below either 7. 0 g/dL (restrictive) or 9. 5 g/dL (liberal). A subgroup of 124 postoperative patients (60 randomized to restrictive and 64 to the liberal group) were analyzed. This study was registered at http://www. controlled-trials. com and carries the following ID ISRCTN37246456. RESULTS Participants in the restrictive and liberal groups were similar at randomization in age (restrictive vs. liberal: 53. 5 +/- 51. 8 vs. 73. 7 +/- 61. 8 months), severity of illness (pediatric risk of mortality [PRISM] score: 3. 5 +/- 4. 0 vs. 4. 4 +/- 4. 0), MODS (35% vs. 29%), need for mechanical ventilation (77% vs. 74%), and hemoglobin level (7. 7 +/- 1. 1 vs. 7. 9 +/- 1. 0 g/dL). The mean hemoglobin level remained 2. 3 g/dL lower in the restrictive group after randomization. No significant differences were found for new or progressive MODS (8% vs. 9%; P = 0. 83) or for 28-day mortality (2% vs. 2%; P = 0. 96) in the restrictive versus liberal group. However, there was a statistically significant difference between groups for PICU length of stay (7. 7 +/- 6. 6 days for the restrictive group vs. 11. 6 +/- 10. 2 days for the liberal group; P = 0. 03). CONCLUSIONS In this subgroup analysis of pediatric general surgery patients, we found no conclusive evidence that a restrictive red-cell transfusion strategy, as compared with a liberal one, increased the rate of new or progressive MODS or mortality.
-
5.
Association between length of storage of transfused red blood cells and multiple organ dysfunction syndrome in pediatric intensive care patients
Gauvin F, Spinella PC, Lacroix J, Choker G, Ducruet T, Karam O, Hébert PC, Hutchison JS, Hume HA, Tucci M, et al
Transfusion. 2010;50((9):):1902-13.
Abstract
BACKGROUND The objective was to determine if there is an association between red blood cell (RBC) storage time and development of new or progressive multiple organ dysfunction syndrome (MODS) in critically ill children. STUDY DESIGN AND METHODS This was an analytic cohort analysis of patients enrolled in a randomized controlled trial, TRIPICU (Transfusion Requirements in Pediatric Intensive Care Units; ISRCTN37246456), in which stable critically ill children were randomly assigned to a restrictive or liberal strategy. Transfused patients were analyzed using three different sliding time cutoffs (7, 14, and 21 days). Storage time for multiply transfused patients was defined according to the oldest unit transfused. RESULTS A total of 455 patients were retained (liberal, 310; restrictive, 145). Multivariate logistic regression was performed to determine independent associations. In the restrictive group, a maximum RBC storage time of more than 21 days was independently associated with new or progressive MODS (adjusted odds ratio [OR], 3. 29; 95% confidence interval [CI], 1. 21-9. 04). The same association was found in the liberal group for a storage time of more than 14 days (adjusted OR, 2. 50; 95% CI, 1. 12-5. 58). When the two groups were combined in a meta-analysis, a storage time of more than 14 days was independently associated with increased MODS (adjusted OR, 2. 23; 95% CI, 1. 20-4. 15) and more than 21 days was associated with increased Pediatric Logistic Organ Dysfunction (PELOD) scores (adjusted mean difference, 4. 26; 95% CI, 1. 99-6. 53) and higher mortality (9. 2% vs. 3. 8%). CONCLUSION Stable critically ill children who receive RBC units with storage times longer than 2 to 3 weeks may be at greater risk of developing new or progressive MODS.
-
6.
Comparison of two red-cell transfusion strategies after pediatric cardiac surgery: a subgroup analysis
Willems A, Harrington K, Lacroix J, Biarent D, Joffe AR, Wensley D, Ducruet T, Hébert PC, Tucci M, TRIPICU investigators, et al
Critical Care Medicine. 2010;38((2):):649-56.
Abstract
OBJECTIVE To determine the impact of a restrictive vs. a liberal transfusion strategy on new or progressive multiple organ dysfunction syndrome in children post cardiac surgery. The optimal transfusion threshold after cardiac surgery in children is unknown. DESIGN Randomized, controlled trial. SETTING Tertiary pediatric intensive care units. PATIENTS Participants are a subgroup of pediatric patients post cardiac surgery from the TRIPICU (Transfusion Requirements in Pediatric Intensive Care Units) study. Exclusion criteria specific to the cardiac surgery subgroup included: age <28 days and patients remaining cyanotic. INTERVENTION Critically ill children with a hemoglobin < or = 95 g/L within 7 days of pediatric intensive care unit admission were randomized to receive prestorage leukocyte-reduced red-cell transfusion if their hemoglobin dropped either <70 g/L (restrictive) or 95 g/L (liberal). MEASUREMENTS AND MAIN RESULTS Postoperative cardiac patients (n = 125) from seven centers were enrolled. The restrictive (n = 63) and liberal (n = 62) groups were similar at baseline in age (mean +/- standard deviation = 31. 4 +/- 38. 1 mos vs. 26. 4 +/- 39. 1 mos), surgical procedure, severity of illness (Pediatric Risk of Mortality score = 3. 4 +/- 3. 2 vs. 3. 2 +/- 3. 2), multiple organ dysfunction syndrome (46% vs. 44%), mechanical ventilation (62% vs. 60%), and hemoglobin (83 vs. 80 g/L). Mean hemoglobin remained 21 g/L lower in the restrictive group after randomization. No significant difference was found in new or progressive multiple organ dysfunction syndrome (primary outcome) in the restrictive group vs. liberal group (12. 7% vs. 6. 5%; p = . 36), pediatric intensive care unit length of stay (7. 0 +/- 5. 0 days vs. 7. 4 +/- 6. 4 days) or 28-day mortality (3. 2% vs. 3. 2%). CONCLUSION In this subgroup analysis of cardiac surgery patients, a restrictive red-cell transfusion strategy, as compared with a liberal one, was not associated with any significant difference in new or progressive multiple organ dysfunction syndrome, but this evidence is not definitive.
-
7.
Transfusion strategies for patients in pediatric intensive care units
Lacroix J, Hébert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, et al
The New England Journal of Medicine. 2007;356((16):):1609-19.
Abstract
BACKGROUND The optimal hemoglobin threshold for erythrocyte transfusions in critically ill children is unknown. We hypothesized that a restrictive transfusion strategy of using packed red cells that were leukocyte-reduced before storage would be as safe as a liberal transfusion strategy, as judged by the outcome of multiple-organ dysfunction. METHODS In this noninferiority trial, we enrolled 637 stable, critically ill children who had hemoglobin concentrations below 9. 5 g per deciliter within 7 days after admission to an intensive care unit. We randomly assigned 320 patients to a hemoglobin threshold of 7 g per deciliter for red-cell transfusion (restrictive-strategy group) and 317 patients to a threshold of 9. 5 g per deciliter (liberal-strategy group). RESULTS Hemoglobin concentrations were maintained at a mean (+/-SD) level that was 2. 1+/-0. 2 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group (lowest average levels, 8. 7+/-0. 4 and 10. 8+/-0. 5 g per deciliter, respectively; P<0. 001). Patients in the restrictive-strategy group received 44% fewer transfusions; 174 patients (54%) in that group did not receive any transfusions, as compared with 7 patients (2%) in the liberal-strategy group (P<0. 001). New or progressive multiple-organ dysfunction syndrome (the primary outcome) developed in 38 patients in the restrictive-strategy group, as compared with 39 in the liberal-strategy group (12% in both groups) (absolute risk reduction with the restrictive strategy, 0. 4%; 95% confidence interval, -4. 6 to 5. 4). There were 14 deaths in each group within 28 days after randomization. No significant differences were found in other outcomes, including adverse events. CONCLUSIONS In stable, critically ill children a hemoglobin threshold of 7 g per deciliter for red-cell transfusion can decrease transfusion requirements without increasing adverse outcomes. (Controlled-trials. com number, ISRCTN37246456 [controlled-trials. com]. ).
-
8.
Is a restrictive transfusion strategy safe for resuscitated and critically ill trauma patients?
McIntyre L, Hebert PC, Wells G, Fergusson D, Marshall J, Yetisir E, Blajchman MJ, Canadian Critical Care Trials Group
The Journal of Trauma. 2004;57((3):):563-8; discussion 568.
Abstract
BACKGROUND An analysis from the prospective multicenter randomized controlled trial (Transfusion Requirements in Critical Care Trial) compared the use of restrictive and liberal transfusion strategies with resuscitated critically ill trauma patients. METHODS Critically ill trauma patients with a hemoglobin concentration less than 90 g/L within 72 hours of admission to the intensive care unit were randomized to a restrictive (hemoglobin concentration, 70 g/L) or liberal (hemoglobin concentration, 100 g/L) red blood cell transfusion strategy. RESULTS The baseline characteristics in the restrictive (n = 100) and liberal (n = 103) transfusion groups were comparable. The average hemoglobin concentrations (82. 7 +/- 6. 2 g/L vs. 104. 3 +/- 12. 2 g/L; p < 0. 0001) and the red blood cell units transfused per patient (2. 3 +/- 4. 4 vs. 5. 4 +/- 4. 3; p < 0. 0001) were significantly lower in the restrictive group than in the liberal group. The 30-day all-cause mortality rates in the restrictive group were 10%, as compared with 9% in the liberal group (p = 0. 81). The presence of multiple organ dysfunction (9. 2 +/- 6. 3 vs. 9. 0 +/- 6. 0; p = 0. 81), the changes in multiple organ dysfunction from baseline scores adjusted for death (1. 2 +/- 6. 1 vs. 1. 9 +/- 5. 7; p = 0. 44), and the length of stay in the intensive care unit (9. 8 +/- 8. 1 vs. 10. 2 +/- 8. 7 days; p = 0. 73) and hospital (31. 4 +/- 17. 1 vs. 33. 7 +/- 17. 7 days; p = 0. 34) also were similar between the restrictive and liberal transfusion groups. CONCLUSIONS A restrictive red blood cell transfusion strategy appears to be safe for critically ill multiple-trauma patients. A randomized controlled trial would provide the appropriate level of evidence with regard to the daily use of blood in this population of patients.