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Importance: The clinical consequences of red blood cell storage age for critically ill pediatric patients have not been examined in a large, randomized clinical trial.Objective: To determine if the transfusion of fresh red blood cells (stored ≤7 days) reduced new or progressive multiple organ dysfunction syndrome compared with the use of standard-issue red blood cells in critically ill children.Design, Setting, and Participants: The Age of Transfused Blood in Critically-Ill Children trial was an international, multicenter, blinded, randomized clinical trial, performed between February 2014 and November 2018 in 50 tertiary care centers. Pediatric patients between the ages of 3 days and 16 years were eligible if the first red blood cell transfusion was administered within 7 days of intensive care unit admission. A total of 15 568 patients were screened, and 13 308 were excluded.Interventions: Patients were randomized to receive either fresh or standard-issue red blood cells. A total of 1538 patients were randomized with 768 patients in the fresh red blood cell group and 770 in the standard-issue group.Main Outcomes and Measures: The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured for 28 days or to discharge or death.Results: Among 1538 patients who were randomized, 1461 patients (95%) were included in the primary analysis (median age, 1.8 years; 47.3% girls), in which there were 728 patients randomized to the fresh red blood cell group and 733 to the standard-issue group. The median storage duration was 5 days (interquartile range [IQR], 4-6 days) in the fresh group vs 18 days (IQR, 12-25 days) in the standard-issue group (P < .001). There were no significant differences in new or progressive multiple organ dysfunction syndrome between fresh (147 of 728 [20.2%]) and standard-issue red blood cell groups (133 of 732 [18.2%]), with an unadjusted absolute risk difference of 2.0% (95% CI, -2.0% to 6.1%; P = .33). The prevalence of sepsis was 25.8% (160 of 619) in the fresh group and 25.3% (154 of 608) in the standard-issue group. The prevalence of acute respiratory distress syndrome was 6.6% (41 of 619) in the fresh group and 4.8% (29 of 608) in the standard-issue group. Intensive care unit mortality was 4.5% (33 of 728) in the fresh group vs 3.5 % (26 of 732) in the standard-issue group (P = .34).Conclusions and Relevance: Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells.Trial Registration: ClinicalTrials.gov Identifier: NCT01977547. [ABSTRACT FROM AUTHOR]

Context: The benefits of therapeutic hypothermia as a treatment for traumatic brain injury (TBI) remain unclear. Objective: To explore the effects of depth, duration, and rate of rewarming after discontinuation of hypothermia on mortality and neurologic outcome in adults after TBI. Data Sources: An electronic search of MEDLINE (OVID), EMBASE, Current Contents, the Cochrane library and a hand search of key journals were performed. Corresponding authors of identified studies were contacted for additional unpublished or ongoing clinical trials. Study Selection: All randomized controlled trials of therapeutic hypothermia for at least 24 hours vs normothermia in adults with TBI. Data Extraction: Demographic and clinical data, hypothermia interventions and cointerventions, mortality and neurologic outcomes, and methodological quality were abstracted by 2 independent reviewers. Data Synthesis: Twelve trials met eligibility criteria and were included in the analysis. We also performed subanalyses by different hypothermia interventions (ie, depth, duration, and rapidity of rewarming after hypothermia) and methodological quality. Therapeutic hypothermia was associated with a 19% reduction in the risk of death (95% confidence interval [CI], 0.69-0.96) and a 22% reduction in the risk of poor neurologic outcome (95% CI, 0.63-0.98) compared with normothermia. Hypothermia longer than 48 hours was associated with a reduction in the risks of death and of poor neurologic outcome (relative risk [RR], 0.70; 95% CI, 0.56-0.87 and RR, 0.65; 95% CI, 0.48-0.89, respectively) compared with normothermia. Hypothermia to a target temperature between 32°C and 33°C, a duration of 24 hours, and rewarming within 24 hours were all associated with reduced risks of poor neurologic outcome compared with normothermia. Assessment of methodological quality did not reveal evidence of bias. Conclusions: Therapeutic hypothermia may reduce the risks of mortality and poor neurologic outcome in... [ABSTRACT FROM AUTHOR]

Context: Leukocytes present in stored blood products can have a variety of biological effects, including depression of immune function, thereby increasing nosocomial infections and possibly resulting in organ failure and death. Premature infants, given their immature immune state, may be uniquely predisposed to the effects of transfused leukocytes. Objective: To evaluate the clinical outcomes following implementation of a universal prestorage red blood cell (RBC) leukoreduction program in premature infants admitted to neonatal intensive care units (NICUs). Design and Setting: Retrospective before-and-after study conducted in 3 Canadian tertiary care NICUs from January 1998 to December 2000. Patients: A total of 515 premature infants weighing less than 1250 g who were admitted to the NICU, received at least 1 RBC transfusion, and survived at least 48 hours were enrolled. The intervention group consisted of infants admitted in the 18-month period following the introduction of universal leukoreduction (n = 247) and the control group consisted of infants admitted during the 18 months prior to the introduction of universal leukoreduction (n = 268). Main Outcome Measures: Primary outcomes were nosocomial bacteremia and NICU mortality, compared before and after implementation of universal leukoreduction using multivariate regression. Secondary outcomes included bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage. Results: The proportion of infants who acquired bacteremia after an RBC transfusion was 79/267 (29.6%) in the nonleukoreduction period and 63/246 (25.6%) in the leukoreduction period. For NICU mortality, there were 45 deaths (16.8%) in the nonleukoreduction period and 44 deaths (17.8%) in the leukoreduction period. The adjusted odds ratio (OR) for bacteremia was 0.59 (95% confidence interval [CI], 0.34-1.01) and for mortality was 1.22 (95% CI, 0.59-2.50). The adjusted ORs for bronchopulmonary... [ABSTRACT FROM AUTHOR]

Context: A number of countries have implemented a policy of universal leukoreduction of their blood supply, but the potential role of leukoreduction in decreasing postoperative mortality and infection is unclear. Objective: To evaluate clinical outcomes following adoption of a national universal prestorage leukoreduction program for blood transfusions. Design, Setting, and Population: Retrospective before-and-after cohort study conducted from August 1998 to August 2000 in 23 academic and community hospitals throughout Canada, enrolling 14 786 patients who received red blood cell transfusions following cardiac surgery or repair of hip fracture, or who required intensive care following a surgical intervention or multiple trauma. Intervention: Universal prestorage leukoreduction program introduced by 2 Canadian blood agencies. A total of 6982 patients were enrolled during the control period and 7804 patients were enrolled following prestorage leukoreduction. Main Outcome Measures: All-cause in-hospital mortality and serious nosocomial infections (pneumonia, bacteremia, septic shock, all surgical site infections) occurring after first transfusion and at least 2 days after index procedure or intensive care unit admission. Secondary outcomes included rates of posttransfusion fever and antibiotic use. Results: Unadjusted in-hospital mortality rates were significantly lower following the introduction of leukoreduction compared with the control period (6.19% vs 7.03%, respectively; P = .04). Compared with the control period, the adjusted odds of death following leukoreduction were reduced (odds ratio [OR], 0.87; 95% confidence interval [CI], 0.75-0.99), but serious nosocomial infections did not decrease (adjusted OR, 0.97; 95% CI, 0.87-1.09). The frequency of posttransfusion fevers decreased significantly following leukoreduction (adjusted OR, 0.86; 95% CI, 0.79-0.94), as did antibiotic use (adjusted OR, 0.90; 95% CI, 0.82-0.99). Conclusion: A national universal... [ABSTRACT FROM AUTHOR]

Editorial. Presents an editorial regarding blood transfusions. Report that patients with cardiovascular diseases and ischemic heart disease may be adversely affected by anemia; Effects of normovolemic anemia on coronary circulation; Reference to a study examining the relationship among anemia, blood transfusion, and survival based on data from three trials involving patients who had an acute myocardial infarction; Statement that the risk of death was 3.94 times higher in patients who underwent transfusion compared with those who did not; Studies to discern whether blood transfusions improve outcomes in patients with ischemic heart disease.

The article focuses on red blood transfusion methods and analyzes two different approaches for the process including lower and higher hemoglobin threshold to minimize the use of red blood cells and reverting any adverse clinical outcomes. It informs that a new research evidence for hematocrit criterion is founded through a study conducted on 600o patients and includes 19 randomized controlled trials. A chart depicting the association if higher and lower levels of hemoglobin threshold in patients with anemia are presented.

The authors discuss modifications to an electronic uniform disclosure form developed by the International Committee of Medical Journal Editors (ICMJE). They cite the complexity of the reporting of competing interests as the main reason for modifying the form based on feedback from authors, editors and other interested parties. Among the modifications were the removal of the queries about potential competing interest of authors' spouses and minor children and the decision to place a numeric designation of each field in the form.

The authors introduce a disclosure form that has been adopted by all journals that are members of the International Committee of Medical Journals Editors (ICMJE). They state that the form is available in the web site of ICMJE and has instructions to help authors provide the information, as well as a sample completed form. They reveal that the disclosure form requires authors to report information about their relationships with entities that could be viewed as having interests that compete with research the being reported.

The authors reflect on the state of clinical trial registration. In 2005, the International Committee of Medical Journal Editors (ICMJE) initiated a policy which required medical investigators to disclose date related to clinical trial designs to a clinical trials registry prior to the enrollment of patients. A reevaluation of the policy is warranted in 2007, and the authors provide recommended modifications to the policy. A brief overview of the clinical trial registration process is provided. Key points discussed in the article include the implementation of the World Health Organization's (WHO) definition of clinical trials in the registry, and the acceptance of clinical trials from any of the major registers from the WHO's International Clinical Trial Registry Platform (ICTRP).

Focuses on research concerning the benefits and risks of red blood cell (RBC) transfusions in critically ill patients. Discussion of a study by Vincent and colleagues in this issue that highlights the frequent use of RBC transfusions in the intensive care unit; Reference to a study by Wu et al of Medicare records of patients with acute myocardial infarction.