OBJECTIVE:Research supports the efficacy and safety of restrictive transfusion protocols to reduce avoidable RBC transfusions, but evidence of their effectiveness in practice is limited. This study ...assessed whether admission to an ICU with an restrictive transfusion protocol reduces the likelihood of transfusion for adult patients.
DESIGN:Observational study using data from the multicenter, cohort Critical Illness Outcomes Study. Patient-level analyses were conducted with RBC transfusion on day of enrollment as the outcome and admission to an ICU with a restrictive transfusion protocol as the exposure of interest. Covariates included demographics, hospital course (e.g., lowest hematocrit, blood loss), severity of illness (e.g., Sequential Organ Failure Assessment score), interventions (e.g., sedation/analgesia), and ICU characteristics (e.g., size). Multivariable logistic regression modeling assessed the independent effects of restrictive transfusion protocols on transfusions.
SETTING:Fifty-nine U.S. ICUs.
PATIENTS:A total of 6,027 adult ICU patients.
INTERVENTIONS:None.
MEASUREMENTS AND MAIN RESULTS:Of the 59 study ICUs, 24 had an restrictive transfusion protocol; 2,510 patients (41.6%) were in an ICU with an restrictive transfusion protocol. The frequency of RBC transfusion among patients with severe (hematocrit, < 21%), moderate (hematocrit, 21–30%), and mild (hematocrit, > 30%) anemia in restrictive transfusion protocol ICUs was 67%, 19%, and 4%, respectively, compared with 60%, 14%, and 2% for those in ICUs without an restrictive transfusion protocol. Only 27% of transfusions were associated with a hematocrit less than 21%. Adjusting for confounding factors, restrictive transfusion protocols independently reduced the odds of transfusion in moderate anemia with an odds ratio of 0.59 (95% CI, 0.36–0.96) while demonstrating no effect in mild (p = 0.93) or severe (p = 0.52) anemia.
CONCLUSIONS:In this sample of ICU patients, transfusions often occurred outside evidence-based guidelines, but admission to an ICU with an restrictive transfusion protocol did reduce the risk of transfusion in moderately anemic patients controlling for patient and ICU factors. This study supports the effectiveness of restrictive transfusion protocols for influencing transfusions in clinical practice.
Abstract Background Context Blood transfusions in spine surgery are shown to be associated with increased patient morbidity. The association between transfusion performed using a liberal hemoglobin ...trigger—defined as an intraoperative hemoglobin level of ≥10 g/dL, a postoperative level of ≥8 g/dL, or a whole hospital nadir between 8-10 g/dL—and perioperative morbidity and cost in spine surgery patients is unknown and thus was investigated in this study. Purpose To describe the perioperative outcomes and economic cost associated with liberal hemoglobin trigger transfusion among spine surgery patients. Study Design/Setting Retrospective study. Patient Sample The surgical billing database at our institution was queried for inpatients discharged between 2008 and 2015 after the following procedures: atlantoaxial fusion, anterior cervical fusion, posterior cervical fusion, anterior lumbar fusion, posterior lumbar fusion, lateral lumbar fusion, other procedures, and tumor-related surgeries. In total, 6931 patients were included for analysis. Outcome Measures The primary outcome was composite morbidity which was comprised of: (1) infection (sepsis, surgical-site infection, Clostridium dificile, or drug-resistant infection), (2) thrombotic event (pulmonary embolus, deep venous thrombosis, or disseminated intravascular coagulation), (3) kidney injury, (4) respiratory event, and/or (5) ischemic event (transient ischemic attack, myocardial infarction, or cerebrovascular accident). Methods Data on intraoperative transfusion were obtained from an automated prospectively collected anesthesia data management system. Data on postoperative hospital transfusion was obtained through a Web-based intelligence portal. Based on previous research, we analyzed the data using three definitions of a liberal transfusion trigger in patients who received an RBC transfusion: a liberal intraoperative Hb trigger as a nadir Hb level of 10 g/dL or greater, a liberal postoperative Hb trigger as a nadir Hb level of 8 g/dL or greater, or a whole hospital nadir Hb level of 8-10 g/dL. Variables analyzed included in-hospital morbidity, mortality, length of stay, and total costs associated with a liberal transfusion strategy. Results Among patients with a whole hospital stay nadir hemoglobin between 8 to 10 g/dL, transfused patients demonstrated a longer in-hospital stay (median IQR, 6 5-9 vs. 4 3-6 days; P<0.0001) and a higher perioperative morbidity (n=145, 11.5% vs. n=74, 6.1%; P<0.0001) than those not transfused. Even after adjusting for age, gender, race, ASA class, CCI score, estimated blood loss, baseline hemoglobin value, number of operated levels, and surgery type, logistic regression analysis revealed that patients with a nadir hemoglobin of 8-10 g/dL who were transfused had an independently higher risk of perioperative morbidity (odds ratio OR = 2.12; 95% confidence interval CI, 1.24-3.64; P=0.006). Estimated additional costs associated with liberal trigger use, defined as a transfusion occurring in patients with a whole hospital stay nadir Hb of 8-10 g/dL, ranged from $202,675 to $700,151 annually. Conclusions Transfusion using a liberal trigger is associated with increased morbidity, even after controlling for possible confounders. Our results suggest that modification of transfusion practice may be a potential area for improving patient outcomes and reducing costs.
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.
The impact of transfusing fresher vs older red blood cells (RBCs) on patient-important outcomes remains controversial. Two recently published large trials have provided new evidence. We summarized ...results of randomized trials evaluating the impact of the age of transfused RBCs. We searched MEDLINE, EMBASE, CINAHL, the Cochrane Database for Systematic Reviews, and Cochrane CENTRAL for randomized controlled trials enrolling patients who were transfused fresher vs older RBCs and reported outcomes of death, adverse events, and infection. Independently and in duplicate, reviewers determined eligibility, risk of bias, and abstracted data. We conducted random effects meta-analyses and rated certainty (quality or confidence) of evidence using the GRADE approach. Of 12 trials that enrolled 5229 participants, 6 compared fresher RBCs with older RBCs and 6 compared fresher RBCs with current standard practice. There was little or no impact of fresher vs older RBCs on mortality (relative risk RR, 1.04; 95% confidence interval CI, 0.94-1.14; P = .45; I2 = 0%, moderate certainty evidence) or on adverse events (RR, 1.02; 95% CI, 0.91-1.14; P = .74; I2 = 0%, low certainty evidence). Fresher RBCs appeared to increase the risk of nosocomial infection (RR, 1.09; 95% CI, 1.00-1.18; P = .04; I2 = 0%, risk difference 4.3%, low certainty evidence). Current evidence provides moderate certainty that use of fresher RBCs does not influence mortality, and low certainty that it does not influence adverse events but could possibly increase infection rates. The existing evidence provides no support for changing practices toward fresher RBC transfusion.
IMPORTANCE: Although millions of transfusions are given annually worldwide, the effect of red blood cell (RBC) unit storage duration on oxygen delivery is uncertain. OBJECTIVE: To determine if ...longer-storage RBC units are not inferior to shorter-storage RBC units for tissue oxygenation as measured by reduction in blood lactate levels and improvement in cerebral tissue oxygen saturation among children with severe anemia. DESIGN, SETTING, AND PARTICIPANTS: Randomized noninferiority trial of 290 children (aged 6-60 months), most with malaria or sickle cell disease, presenting February 2013 through May 2015 to a university-affiliated national referral hospital in Kampala, Uganda, with a hemoglobin level of 5 g/dL or lower and a lactate level of 5 mmol/L or higher. INTERVENTIONS: Patients were randomly assigned to receive RBC units stored 25 to 35 days (longer-storage group; n = 145) vs 1 to 10 days (shorter-storage group; n = 145). All units were leukoreduced prior to storage. All patients received 10 mL/kg of RBCs during hours 0 through 2 and, if indicated per protocol, an additional 10 mL/kg during hours 4 through 6. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients with a lactate level of 3 mmol/L or lower at 8 hours using a margin of noninferiority equal to an absolute difference of 25%. Secondary measures included noninvasive cerebral tissue oxygen saturation during the first transfusion, clinical and laboratory changes up to 24 hours, and survival and health at 30 days after transfusion. Adverse events were monitored up to 24 hours. RESULTS: In the total population of 290 children, the mean (SD) presenting hemoglobin level was 3.7 g/dL (1.3) and mean lactate level was 9.3 mmol/L (3.4). Median (interquartile range) RBC unit storage was 8 days (7-9) for shorter storage vs 32 days (30-34) for longer storage without overlap. The proportion achieving the primary end point was 0.61 (95% CI, 0.52 to 0.69) in the longer-storage group vs 0.58 (95% CI, 0.49 to 0.66) in the shorter-storage group (between-group difference, 0.03 95% CI, −0.07 to ∞, P < .001), meeting the prespecified margin of noninferiority. Mean lactate levels were not statistically different between the 2 groups at 0, 2, 4, 6, 8, or 24 hours. Kaplan-Meier analysis and global nonlinear regression revealed no statistical difference in lactate reduction between the 2 groups. Clinical assessment, cerebral oxygen saturation, electrolyte abnormalities, adverse events, survival, and 30-day recovery were also not significantly different between the groups. CONCLUSIONS AND RELEVANCE: Among children with lactic acidosis due to severe anemia, transfusion of longer-storage compared with shorter-storage RBC units did not result in inferior reduction of elevated blood lactate levels. These findings have relevance regarding the efficacy of stored RBC transfusion for patients with critical tissue hypoxia and lactic acidosis due to anemia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01586923
BACKGROUND:It is unclear whether transfusion of platelets or fresh frozen plasma, in addition to red blood cells, is associated with an increased risk of mortality and infection after cardiac ...surgery.
METHODS:Patients who underwent valve surgery and/or coronary artery bypass grafting from January 1, 2011 to June 30, 2017 and September 1, 2013 to June 30, 2017 at 2 centers performing cardiac surgery were included in this retrospective study. After stratifying patients based on propensity score matching, we compared rates of mortality and infection between patients who transfused red blood cells, fresh frozen plasma, or platelets with those who did not receive such transfusions. We also compared outcomes between patients who received any of the 3 blood products and patients who received no transfusions at all. Multivariable logistic regression was used to assess associations between transfusion and outcomes.
RESULTS:Of 8238 patients in this study, 109 (1.3%) died, 812 (9.9%) experienced infection, and 4937 (59.9%) received at least 1 type of blood product. Transfusion of any blood type was associated with higher rates of mortality (2.0% vs 0.18%; P < .01) and infection (13.3% vs 4.8%; P < .01). Each of the 3 blood products was independently associated with an increase in mortality per unit transfused (red blood cells, odds ratio 1.18, 95% confidence interval CI, 1.14–1.22; fresh frozen plasma, odds ratio 1.24, 95% CI, 1.18–1.30; platelets, odds ratio 1.12, 95% CI, 1.07–1.18). Transfusing 3 units of any of the 3 blood products was associated with a dose-dependent increase in the incidence of mortality (odds ratio 1.88, 95% CI, 1.70–2.08) and infection (odds ratio 1.50, 95% CI, 1.43–1.57).
CONCLUSIONS:Transfusion of red blood cells, fresh frozen plasma, or platelets is an independent risk factor of mortality and infection, and combination of the 3 blood products is associated with adverse outcomes after cardiac surgery in a dose-dependent manner.
Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients, but there is no clear evidence to support the superiority of ...any perioperative transfusion strategy in patients with cancer.
In a randomized, controlled, parallel-group, double-blind (patients and outcome assessors) superiority trial in the intensive care unit of a tertiary oncology hospital, the authors evaluated whether a restrictive strategy of erythrocyte transfusion (transfusion when hemoglobin concentration <7 g/dl) was superior to a liberal one (transfusion when hemoglobin concentration <9 g/dl) for reducing mortality and severe clinical complications among patients having major cancer surgery. All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and randomly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy. The primary outcome was a composite endpoint of mortality and morbidity.
A total of 198 patients were included as follows: 101 in the restrictive group and 97 in the liberal group. The primary composite endpoint occurred in 19.6% (95% CI, 12.9 to 28.6%) of patients in the liberal-strategy group and in 35.6% (27.0 to 45.4%) of patients in the restrictive-strategy group (P = 0.012). Compared with the restrictive strategy, the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16% (3.8 to 28.2%) and a number needed to treat of 6.2 (3.5 to 26.5).
A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy.
IMPORTANCE: There is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold after a traumatic brain injury. OBJECTIVE: To compare the effects of ...erythropoietin and 2 hemoglobin transfusion thresholds (7 and 10 g/dL) on neurological recovery after traumatic brain injury. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of 200 patients (erythropoietin, n = 102; placebo, n = 98) with closed head injury who were unable to follow commands and were enrolled within 6 hours of injury at neurosurgical intensive care units in 2 US level I trauma centers between May 2006 and August 2012. The study used a factorial design to test whether erythropoietin would fail to improve favorable outcomes by 20% and whether a hemoglobin transfusion threshold of greater than 10 g/dL would increase favorable outcomes without increasing complications. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (n = 74) and then the 24- and 48-hour doses were stopped for the remainder of the patients (n = 126). There were 99 patients assigned to a hemoglobin transfusion threshold of 7 g/dL and 101 patients assigned to 10 g/dL. INTERVENTIONS: Intravenous erythropoietin (500 IU/kg per dose) or saline. Transfusion threshold maintained with packed red blood cells. MAIN OUTCOMES AND MEASURES: Glasgow Outcome Scale score dichotomized as favorable (good recovery and moderate disability) or unfavorable (severe disability, vegetative, or dead) at 6 months postinjury. RESULTS: There was no interaction between erythropoietin and hemoglobin transfusion threshold. Compared with placebo (favorable outcome rate: 34/89 38.2%; 95% CI, 28.1% to 49.1%), both erythropoietin groups were futile (first dosing regimen: 17/35 48.6%; 95% CI, 31.4% to 66.0%, P = .13; second dosing regimen: 17/57 29.8%; 95% CI, 18.4% to 43.4%, P < .001). Favorable outcome rates were 37/87 (42.5%) for the hemoglobin transfusion threshold of 7 g/dL and 31/94 (33.0%) for 10 g/dL (95% CI for the difference, −0.06 to 0.25, P = .28). There was a higher incidence of thromboembolic events for the transfusion threshold of 10 g/dL (22/101 21.8% vs 8/99 8.1% for the threshold of 7 g/dL, odds ratio, 0.32 95% CI, 0.12 to 0.79, P = .009). CONCLUSIONS AND RELEVANCE: In patients with closed head injury, neither the administration of erythropoietin nor maintaining hemoglobin concentration of greater than 10 g/dL resulted in improved neurological outcome at 6 months. The transfusion threshold of 10 g/dL was associated with a higher incidence of adverse events. These findings do not support either approach in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00313716
BACKGROUND: Blood utilization has long been suspected to consume more health care resources than previously reported. Incomplete accounting for blood costs has the potential to misdirect programmatic ...decision making by health care systems. Determining the cost of supplying patients with blood transfusions requires an in‐depth examination of the complex array of activities surrounding the decision to transfuse.
STUDY DESIGN AND METHODS: To accurately determine the cost of blood in a surgical population from a health system perspective, an activity‐based costing (ABC) model was constructed. Tasks and resource consumption (materials, labor, third‐party services, capital) related to blood administration were identified prospectively at two US and two European hospitals. Process frequency (i.e., usage) data were captured retrospectively from each hospital and used to populate the ABC model.
RESULTS: All major process steps, staff, and consumables to provide red blood cell (RBC) transfusions to surgical patients, including usage frequencies, and direct and indirect overhead costs contributed to per‐RBC‐unit costs between $522 and $1183 (mean, $761 ± $294). These exceed previously reported estimates and were 3.2‐ to 4.8‐fold higher than blood product acquisition costs. Annual expenditures on blood and transfusion‐related activities, limited to surgical patients, ranged from $1.62 to $6.03 million per hospital and were largely related to the transfusion rate.
CONCLUSION: Applicable to various hospital practices, the ABC model confirms that blood costs have been underestimated and that they are geographically variable and identifies opportunities for cost containment. Studies to determine whether more stringent control of blood utilization improves health care utilization and quality, and further reduces costs, are warranted.
Reducing blood product utilization after cardiac surgery has become a focus of perioperative care as studies have suggested improved outcomes. The relative impact of preoperative anemia versus packed ...red blood cells (PRBC) transfusion on outcomes remains poorly understood, however. In this study, we investigated the relative association between preoperative hematocrit (Hct) level and PRBC transfusion on postoperative outcomes after coronary artery bypass grafting (CABG) surgery.
Patient records for primary, isolated CABG operations performed between January 2007 and December 2017 at 19 cardiac surgery centers were evaluated. Hierarchical logistic regression modeling was used to estimate the relationship between baseline preoperative Hct level as well as PRBC transfusion and the likelihoods of postoperative mortality and morbidity, adjusted for baseline patient risk. Variable and model performance characteristics were compared to determine the relative strength of association between Hct level and PRBC transfusion and primary outcomes.
A total of 33,411 patients (median patient age, 65 years; interquartile range IQR, 57-72 years; 26% females) were evaluated. The median preoperative Hct value was 39% (IQR, 36%-42%), and the mean Society of Thoracic Surgeons (STS) predicted risk of mortality was 1.8 ± 3.1%. Complications included PRBC transfusion in 31% of patients, renal failure in 2.8%, stroke in 1.3%, and operative mortality in 2.0%. A strong association was observed between preoperative Hct value and the likelihood of PRBC transfusion (P < .001). After risk adjustment, PRBC transfusion, but not Hct value, demonstrated stronger associations with postoperative mortality (odds ratio OR, 4.3; P < .0001), renal failure (OR 6.3; P < .0001), and stroke (OR, 2.4; P < .0001). A 1-point increase in preoperative Hct was associated with decreased probabilities of mortality (OR, 0.97; P = .0001) and renal failure (OR, 0.94; P < .0001). The models with PRBC had superior predictive power, with a larger area under the curve, compared with Hct for all outcomes (all P < .01). Preoperative anemia was associated with up to a 4-fold increase in the probability of PRBC transfusion, a 3-fold increase in renal failure, and almost double the mortality.
PRBC transfusion appears to be more closely associated with risk-adjusted morbidity and mortality compared with preoperative Hct level alone, supporting efforts to reduce unnecessary PRBC transfusions. Preoperative anemia independently increases the risk of postoperative morbidity and mortality. These data suggest that preoperative Hct should be included in the STS risk calculators. Finally, efforts to optimize preoperative hematocrit should be investigated as a potentially modifiable risk factor for mortality and morbidity.
PDF
