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In patients with myocardial infarction and anemia, a liberal transfusion strategy led to fewer deaths and heart attacks than a restricted transfusion strategy, but the difference was of borderline significance.

Objective To compare the benefit and harm of restrictive versus liberal transfusion strategies to guide red blood cell transfusions.Design Systematic review with meta-analyses and trial sequential analyses of randomised clinical trials.Data sources Cochrane central register of controlled trials, SilverPlatter Medline (1950 to date), SilverPlatter Embase (1980 to date), and Science Citation Index Expanded (1900 to present). Reference lists of identified trials and other systematic reviews were assessed, and authors and experts in transfusion were contacted to identify additional trials.Trial selection Published and unpublished randomised clinical trials that evaluated a restrictive compared with a liberal transfusion strategy in adults or children, irrespective of language, blinding procedure, publication status, or sample size.Data extraction Two authors independently screened titles and abstracts of trials identified, and relevant trials were evaluated in full text for eligibility. Two reviewers then independently extracted data on methods, interventions, outcomes, and risk of bias from included trials. random effects models were used to estimate risk ratios and mean differences with 95% confidence intervals.Results 31 trials totalling 9813 randomised patients were included. The proportion of patients receiving red blood cells (relative risk 0.54, 95% confidence interval 0.47 to 0.63, 8923 patients, 24 trials) and the number of red blood cell units transfused (mean difference −1.43, 95% confidence interval −2.01 to −0.86) were lower with the restrictive compared with liberal transfusion strategies. Restrictive compared with liberal transfusion strategies were not associated with risk of death (0.86, 0.74 to 1.01, 5707 patients, nine lower risk of bias trials), overall morbidity (0.98, 0.85 to 1.12, 4517 patients, six lower risk of bias trials), or fatal or non-fatal myocardial infarction (1.28, 0.66 to 2.49, 4730 patients, seven lower risk of bias trials). Results were not affected by the inclusion of trials with unclear or high risk of bias. Using trial sequential analyses on mortality and myocardial infarction, the required information size was not reached, but a 15% relative risk reduction or increase in overall morbidity with restrictive transfusion strategies could be excluded.Conclusions Compared with liberal strategies, restrictive transfusion strategies were associated with a reduction in the number of red blood cell units transfused and number of patients being transfused, but mortality, overall morbidity, and myocardial infarction seemed to be unaltered. Restrictive transfusion strategies are safe in most clinical settings. Liberal transfusion strategies have not been shown to convey any benefit to patients.Trial registration PROSPERO CRD42013004272.

The effect of a liberal transfusion strategy as compared with a restrictive strategy on outcomes in critically ill patients with traumatic brain injury is unclear. We randomly assigned adults with moderate or severe traumatic brain injury and anemia to receive transfusion of red cells according to a liberal strategy (transfusions initiated at a hemoglobin level of ≤10 g per deciliter) or a restrictive strategy (transfusions initiated at ≤7 g per deciliter). The primary outcome was an unfavorable outcome as assessed by the score on the Glasgow Outcome Scale-Extended at 6 months, which we categorized with the use of a sliding dichotomy that was based on the prognosis of each patient at baseline. Secondary outcomes included mortality, functional independence, quality of life, and depression at 6 months. A total of 742 patients underwent randomization, with 371 assigned to each group. The analysis of the primary outcome included 722 patients. The median hemoglobin level in the intensive care unit was 10.8 g per deciliter in the group assigned to the liberal strategy and 8.8 g per deciliter in the group assigned to the restrictive strategy. An unfavorable outcome occurred in 249 of 364 patients (68.4%) in the liberal-strategy group and in 263 of 358 (73.5%) in the restrictive-strategy group (adjusted absolute difference, restrictive strategy vs. liberal strategy, 5.4 percentage points; 95% confidence interval, -2.9 to 13.7). Among survivors, a liberal strategy was associated with higher scores on some but not all the scales assessing functional independence and quality of life. No association was observed between the transfusion strategy and mortality or depression. Venous thromboembolic events occurred in 8.4% of the patients in each group, and acute respiratory distress syndrome occurred in 3.3% and 0.8% of patients in the liberal-strategy and restrictive-strategy groups, respectively. In critically ill patients with traumatic brain injury and anemia, a liberal transfusion strategy did not reduce the risk of an unfavorable neurologic outcome at 6 months. (Funded by the Canadian Institutes of Health Research and others; HEMOTION ClinicalTrials.gov number, NCT03260478.).

In a trial involving patients with subarachnoid hemorrhage and anemia, liberal transfusion of red cells did not result in a lower risk of an unfavorable neurologic outcome than a more restrictive strategy.

A randomized clinical trial shows that among patients with upper GI bleeding, withholding transfusion until the hemoglobin level falls below 7 g per deciliter results in better outcomes than using 9 g per deciliter as the trigger for transfusion. Acute upper gastrointestinal bleeding is a common emergency condition associated with high morbidity and mortality. 1 It is a frequent indication for red-cell transfusion, because acute blood loss can decrease tissue perfusion and the delivery of oxygen to tissues. Transfusion may be lifesaving in patients with massive exsanguinating bleeding. However, in most cases hemorrhage is not so severe, and in such circumstances the safest and most effective transfusion strategy is controversial. 2 , 3 Restricted transfusion strategies may be appropriate in some settings. Controlled trials have shown that for critically ill patients, a restrictive transfusion strategy is at least as effective as a . . .

In a randomized trial, 5243 patients undergoing cardiac surgery were assigned to a restrictive or a liberal red-cell transfusion threshold. The restrictive threshold was noninferior to the liberal one for the composite outcome of death, myocardial infarction, stroke, or renal failure.

Transfusion thresholds for acute upper gastrointestinal bleeding are controversial. So far, only three small, underpowered studies and one single-centre trial have been done. Findings from the single-centre trial showed reduced mortality with restrictive red blood cell (RBC) transfusion. We aimed to assess whether a multicentre, cluster randomised trial is a feasible method to substantiate or refute this finding. In this pragmatic, open-label, cluster randomised feasibility trial, done in six university hospitals in the UK, we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding, irrespective of comorbidity, except for exsanguinating haemorrhage. We randomly assigned hospitals (1:1) with a computer-generated randomisation sequence (random permuted block size of 6, without stratification or matching) to either a restrictive (transfusion when haemoglobin concentration fell below 80 g/L) or liberal (transfusion when haemoglobin concentration fell below 100 g/L) RBC transfusion policy. Neither patients nor investigators were masked to treatment allocation. Feasibility outcomes were recruitment rate, protocol adherence, haemoglobin concentration, RBC exposure, selection bias, and information to guide design and economic evaluation of the phase 3 trial. Main exploratory clinical outcomes were further bleeding and mortality at day 28. We did analyses on all enrolled patients for whom an outcome was available. This trial is registered, ISRCTN85757829 and NCT02105532. Between Sept 3, 2012, and March 1, 2013, we enrolled 936 patients across six hospitals (403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy). Recruitment rate was significantly higher for the liberal than for the restrictive policy (62% vs 55%; p=0·04). Despite some baseline imbalances, Rockall and Blatchford risk scores were identical between policies. Protocol adherence was 96% (SD 10) in the restrictive policy vs 83% (25) in the liberal policy (difference 14%; 95% CI 7–21; p=0·005). Mean last recorded haemoglobin concentration was 116 (SD 24) g/L for patients on the restrictive policy and 118 (20) g/L for those on the liberal policy (difference −2·0 [95% CI −12·0 to 7·0]; p=0·50). Fewer patients received RBCs on the restrictive policy than on the liberal policy (restrictive policy 133 [33%] vs liberal policy 247 [46%]; difference −12% [95% CI −35 to 11]; p=0·23), with fewer RBC units transfused (mean 1·2 [SD 2·1] vs 1·9 [2·8]; difference −0·7 [–1·6 to 0·3]; p=0·12), although these differences were not significant. We noted no significant difference in clinical outcomes. A cluster randomised design led to rapid recruitment, high protocol adherence, separation in degree of anaemia between groups, and non-significant reduction in RBC transfusion in the restrictive policy. A large cluster randomised trial to assess the effectiveness of transfusion strategies for acute upper gastrointestinal bleeding is both feasible and essential before clinical practice guidelines change to recommend restrictive transfusion for all patients with acute upper gastrointestinal bleeding. NHS Blood and Transplant Research and Development.

In this large randomized trial involving patients undergoing cardiac surgery who were at moderate-to-high risk, the outcomes at 6 months show that a restrictive red-cell transfusion strategy was noninferior to a liberal strategy with respect to the composite outcome.

Background The optimal hemoglobin (Hb) threshold to trigger red blood cell transfusions (RBCT) in subarachnoid hemorrhage (SAH) patients is unclear. This study evaluated the impact of liberal versus restrictive transfusion strategies on neurological outcome in patients with SAH. Methods This is a pre-planned secondary analysis of the “TRansfusion Strategies in Acute brain INjured Patients” (TRAIN) study. We included all SAH patients from the original study that were randomized to receive RBCT when Hb levels dropped below 9 g/dL (liberal group) or 7 g/dL (restrictive group). The primary outcome was an unfavorable neurological outcome at 180 days, defined by a Glasgow Outcome Scale Extended score of 1–5. Results Of the 190 SAH patients in the trial, 188 (98.9%) had data available for the primary outcome, with 86 (45.3%) in the liberal group and 102 (53.6%) in the restrictive group. Patients in the liberal group were older than in the restrictive group, but otherwise had similar baseline characteristics. Patients in the liberal group received more RBCT and showed higher Hb levels over time. At 180 days, 57 (66.3%) patients in the liberal group and 78 (76.4%) in the restrictive group had unfavorable outcomes (risk ratio, RR 0.87; 95% confidence intervals, 95% CI 0.71–1.04). Patients in the liberal group had a significantly lower risk of cerebral ischemia (RR 0.63; 95% CI 0.41–0.97). In a multivariate analysis, randomization to the liberal group was associated with a lower risk of unfavorable outcome (RR 0.83, 95% CI 0.70–0.99). Conclusions A liberal transfusion strategy was not associated with a lower incidence of unfavorable outcome after SAH when compared to a restrictive strategy. However, in a multivariable analysis adjusted for confounders randomization to the liberal group was associated with lower risk of unfavorable outcome. The occurrence of cerebral ischemia was significantly lower in the liberal transfusion strategy group. Trial registration ClinicalTrials.gov number—NCT02968654 registered on November 16th, 2016.

Patients who undergo cardiac surgery have a high risk of significant blood loss and anemia. While allogeneic red blood cell (RBC) transfusions are effective, they are associated with increased morbidity and mortality. Intraoperative cell salvage may reduce reliance on allogeneic transfusions. Although intraoperative RBC salvage is recommended for cardiovascular surgery under cardiopulmonary bypass, there are concerns about increased bleeding due to coagulopathy in patients with a high bleeding risk, and its clinical impact remains unclear. This study aims to evaluate whether salvaged RBC transfusion is noninferior to allogeneic transfusion in terms of postoperative blood loss in patients with a high bleeding risk. This single-center, randomized, two-arm, parallel group, interventional clinical trial will include 142 participants aged ≥ 40 years with a high bleeding risk who undergo elective cardiovascular surgery with cardiopulmonary bypass. Participants will be randomly assigned to receive either salvaged RBC or allogeneic RBC transfusions intraoperatively. The primary outcome is postoperative chest tube blood loss within 12 hours from the end of surgery. Noninferiority will be demonstrated if the upper limit of the 95% confidence interval for the mean difference in blood loss between the salvaged and allogeneic groups is < 200 mL. Secondary outcomes comprise the RBC transfusion volume intraoperatively and for 12 hours from the end of surgery, prevalence of re-thoracotomy within 48 hours from the end of surgery, and prevalence of ≥ 1000 mL postoperative chest tube blood loss within 12 hours from the end of surgery. These outcomes will be analyzed using the modified intention-to-treat set and repeated, for sensitivity reasons, for the per-protocol set. Our trial aims to determine the noninferiority of intraoperative RBC salvage compared with allogeneic blood transfusions regarding postoperative blood loss and to promote its use in surgical procedures with a high bleeding risk. The trial was registered with the Japan Registry of Clinical Trials (jRCT1052240102) on July 30, 2024.