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Orthopaedic Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective Randomized Study
Mullis, B. H., Mullis, L. S., Kempton, L. B., Virkus, W., Slaven, J. E., Bruggers, J.
Journal of orthopaedic trauma. 2024;38(1):18-24
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Editor's Choice
Abstract
OBJECTIVES To determine whether it is safe to use a conservative packed red blood cell transfusion hemoglobin (Hgb) threshold (5.5 g/dL) compared with a liberal transfusion threshold (7.0 g/dL) for asymptomatic musculoskeletal injured trauma patients who are no longer in the initial resuscitative period. METHODS Design: Prospective, randomized, multicenter trial. SETTING Three level 1 trauma centers. PATIENT SELECTION CRITERIA Patients aged 18-50 with an associated musculoskeletal injury with Hgb less than 9 g/dL or expected drop below 9 g/dL with planned surgery who were stable and no longer being actively resuscitated were randomized once their Hgb dropped below 7 g/dL to a conservative transfusion threshold of 5.5 g/dL versus a liberal threshold of 7.0 g/dL. OUTCOME MEASURES AND COMPARISONS Postoperative infection, other post-operative complications and Musculoskeletal Functional Assessment scores obtained at baseline, 6 months, and 1 year were compared for liberal and conservative transfusion thresholds. RESULTS Sixty-five patients completed 1 year follow-up. There was a significant association between a liberal transfusion strategy and higher rate of infection (P = 0.01), with no difference in functional outcomes at 6 months or 1 year. This study was adequately powered at 92% to detect a difference in superficial infection (7% for liberal group, 0% for conservative, P < 0.01) but underpowered to detect a difference for deep infection (14% for liberal group, 6% for conservative group, P = 0.2). CONCLUSIONS A conservative transfusion threshold of 5.5 g/dL in an asymptomatic young trauma patient with associated musculoskeletal injuries leads to a lower infection rate without an increase in adverse outcomes and no difference in functional outcomes at 6 months or 1 year. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
PICO Summary
Population
Musculoskeletal trauma patients with planned surgery (n= 99).
Intervention
Liberal transfusion threshold of 7.0 g/dL (n= 49).
Comparison
Conservative transfusion threshold of 5.5 g/dL (n= 50).
Outcome
Overall, 46/49 (93.9%) of the liberal group had a transfusion versus 23/50 (46.0%) of the conservative group had a transfusion after resuscitation and after enrollment in this study. Following resuscitation and enrollment in the study, patients in the liberal group received a median of 1 unit of blood transfused (range 0–12) and patients in the conservative group received a median of 0 units of blood (range 0–14). Sixty-five patients completed 1- year follow-up. There was a significant association between a liberal transfusion strategy and higher rate of infection, with no difference in functional outcomes at 6 months or 1 year.
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Red cell transfusion thresholds in outpatients with myelodysplastic syndromes: Results of a pilot randomized trial RBC-ENHANCE
Buckstein, R., Callum, J., Prica, A., Bowen, D., Wells, R. A., Leber, B., Heddle, N., Chodirker, L., Cheung, M., Mozessohn, L., et al
Transfusion. 2024
Abstract
BACKGROUND The optimal hemoglobin (Hb) threshold for red blood cell transfusions in adult patients with myelodysplastic syndromes (MDS) has not been defined. STUDY DESIGN AND METHODS We conducted a pilot randomized multi-center study of two transfusion algorithms (liberal, to maintain Hb 110-120 g/L, transfuse 2 units if Hb < 105 g/L and 1 unit if Hb 105-110 g/L vs. restrictive, 85-105 g/L, transfuse 2 units when Hgb < 85 g/L). Primary objectives were 70% compliance in maintaining the q2 week hemoglobin within the targeted range and the achievement of a 15 g/L difference in pre-transfusion Hb. Secondary outcomes included measures of quality of life (QOL), iron studies and safety. RESULTS Twenty-eight patients were randomized between February 2015-2020, 13 to the restrictive arm and 15 to the liberal arm in three tertiary care centers. The compliance was 66% and 45% and the mean pre-transfusion Hb thresholds were 86 (standard deviation [SD] 8) and 98 g/L (SD 10) in the restrictive and liberal arms, (mean difference 11.8 g/L, p < .0001), respectively. Patients in the liberal arm experienced a mean of 3.4 (SD 2.6) more transfusion visits and received a mean of 5.3 (SD 5.5) more units of blood during the 12-week study. Ferritin increased by 1043 (SD 1516) IU/L and 148 (SD 1319) IU/L in the liberal and restrictive arms, respectively. Selected QOL scores were superior pre-transfusion and more patients achieved clinically important improvements in the liberal arm compared with the restrictive arm for selected symptoms and function domains. CONCLUSION The results establish that policies for transfusion support can be delivered in practice at multiple hospitals, but further research is required to understand the full clinical effects and safety of liberal transfusion policies in MDS outpatients.
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Early Results of Orthopaedic Trauma and Anemia: Conservative Versus Liberal Transfusion Strategy
Mullis, B. H., Mullis, L. S., Kempton, L. B., Virkus, W., Slaven, J. E., Bruggers, J.
The Journal of the American Academy of Orthopaedic Surgeons. 2023
Abstract
INTRODUCTION The purpose of this study was to determine whether it is safe to use a conservative packed red blood cell transfusion hemoglobin threshold (5.5 g/dL) compared with a liberal transfusion threshold (7.0 g/dL) for asymptomatic patients with musculoskeletal-injured trauma out of the initial resuscitative period. METHODS This was a multicenter, prospective, nonblinded, randomized study done at three level 1 trauma centers. One hundred patients were enrolled. One patient was inappropriately enrolled, withdrawn from the study, and excluded from analysis leaving 99 patients (49 liberal and 50 conservative) with 30-day follow-up. After initial resuscitation, patients were enrolled and randomized to either a liberal or a conservative transfusion strategy. This strategy was followed throughout the index hospitalization. The primary outcome of the study was infection. Superficial infection was defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only. Deep infection was defined as clinical diagnosis of fracture-related infection requiring IV antibiotics and/or surgical débridement. RESULTS Ninety-nine patients were successfully followed for 30 days with 100% follow-up during this time. Seven infections (14%) occurred in the liberal group and none in the conservative group (P < 0.01). Five deep infections (10%) occurred in the liberal group and none in the conservative group (P = 0.03). Three superficial infections (6%) occurred in the liberal and none in the conservative group, which was not a significant difference (P = 0.1). No difference was observed in length of stay between groups. DISCUSSION Transfusing young healthy asymptomatic patients with orthopaedic trauma for hemoglobin <7.0 g/dL increases the risk of infection. No increased risk of anemia-related complications was identified with a conservative transfusion threshold of 5.5 g/dL. DATA AVAILABILITY AND TRIAL REGISTRATION NUMBERS Data are available on request. IRB protocol number is 1402557771. This study was registered with Clinicaltrials.gov identifier NCT02972593. LEVEL OF EVIDENCE Level 2, unblinded prospective randomized multicenter study.
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Association of Trauma Molecular Endotypes With Differential Response to Transfusion Resuscitation Strategies
Thau MR, Liu T, Sathe NA, O'Keefe GE, Robinson BRH, Bulger E, Wade CE, Fox EE, Holcomb JB, Liles WC, et al
JAMA surgery. 2023
Abstract
IMPORTANCE It is not clear which severely injured patients with hemorrhagic shock may benefit most from a 1:1:1 vs 1:1:2 (plasma:platelets:red blood cells) resuscitation strategy. Identification of trauma molecular endotypes may reveal subgroups of patients with differential treatment response to various resuscitation strategies. OBJECTIVE To derive trauma endotypes (TEs) from molecular data and determine whether these endotypes are associated with mortality and differential treatment response to 1:1:1 vs 1:1:2 resuscitation strategies. DESIGN, SETTING, AND PARTICIPANTS This was a secondary analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) randomized clinical trial. The study cohort included individuals with severe injury from 12 North American trauma centers. The cohort was taken from the participants in the PROPPR trial who had complete plasma biomarker data available. Study data were analyzed on August 2, 2021, to October 25, 2022. EXPOSURES TEs identified by K-means clustering of plasma biomarkers collected at hospital arrival. MAIN OUTCOMES AND MEASURES An association between TEs and 30-day mortality was tested using multivariable relative risk (RR) regression adjusting for age, sex, trauma center, mechanism of injury, and injury severity score (ISS). Differential treatment response to transfusion strategy was assessed using an RR regression model for 30-day mortality by incorporating an interaction term for the product of endotype and treatment group adjusting for age, sex, trauma center, mechanism of injury, and ISS. RESULTS A total of 478 participants (median [IQR] age, 34.5 [25-51] years; 384 male [80%]) of the 680 participants in the PROPPR trial were included in this study analysis. A 2-class model that had optimal performance in K-means clustering was found. TE-1 (n = 270) was characterized by higher plasma concentrations of inflammatory biomarkers (eg, interleukin 8 and tumor necrosis factor α) and significantly higher 30-day mortality compared with TE-2 (n = 208). There was a significant interaction between treatment arm and TE for 30-day mortality. Mortality in TE-1 was 28.6% with 1:1:2 treatment vs 32.6% with 1:1:1 treatment, whereas mortality in TE-2 was 24.5% with 1:1:2 treatment vs 7.3% with 1:1:1 treatment (P for interaction = .001). CONCLUSIONS AND RELEVANCE Results of this secondary analysis suggest that endotypes derived from plasma biomarkers in trauma patients at hospital arrival were associated with a differential response to 1:1:1 vs 1:1:2 resuscitation strategies in trauma patients with severe injury. These findings support the concept of molecular heterogeneity in critically ill trauma populations and have implications for tailoring therapy for patients at high risk for adverse outcomes.
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Red cell transfusion thresholds in outpatients with myelodysplastic syndromes: Combined results from two randomized controlled feasibility studies
Buckstein, R., Callum, J., Prica, A., Bowen, D., Wells, R. A., Leber, B., Heddle, N., Chodirker, L., Cheung, M., Mozessohn, L., et al
American journal of hematology. 2023
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Editor's Choice
PICO Summary
Population
Red blood cell, transfusion dependent patients with myelodysplastic syndromes enrolled in two feasibility trials: REDDS in United Kingdom, Australia and New Zealand, and RBC-Enhance in Canada (n= 66).
Intervention
Liberal transfusion strategy (maintain Hb 110-125 g/L), (n= 33).
Comparison
Restrictive transfusion strategy (maintain Hb 85-100 g/L), (n= 33).
Outcome
The transfusion strategy was applied for 12 weeks. In total, 232 and 471 units of red blood cells were transfused in the restrictive and liberal arms, respectively. Patients in the liberal arm had more complete blood count tests (13.8 vs. 10.3), a mean of 3.1 ± 2.9 more transfusion visits, and a mean of 6.3 ± 5.9 extra units of blood. Overall, the authors of this combined analysis of two feasibility trials, observed less variability in Hb levels in the liberal arm with patients reporting clinically important improvements pre- and post-transfusion (compared with baseline) in selected symptom and functional domains. However, many patients in both transfusion arms experienced stability or declines in their scores.
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Pegcetacoplan controls hemolysis in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria
Wong RSM, Navarro-Cabrera JR, Comia NS, Goh YT, Idrobo H, Kongkabpan D, Gómez-Almaguer D, Al-Adhami M, Ajayi T, Alvarenga P, et al
Blood advances. 2023
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Editor's Choice
Abstract
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare disease characterized by complement-mediated hemolysis. Pegcetacoplan is the first C3-targeted therapy approved for adults with PNH (United States), adults with PNH with inadequate response to or intolerance of a C5 inhibitor (Australia), and adults with anemia despite C5-targeted therapy for 3 months (European Union). PRINCE was a phase 3, randomized, multicenter, open-label, controlled study to evaluate efficacy and safety of pegcetacoplan versus control (supportive care only; eg, blood transfusions, corticosteroids, and supplements) in complement inhibitor-naive patients with PNH. Eligible adults receiving supportive care only for PNH were randomized and stratified based on their number of transfusions (<4, ≥4) 12 months before screening. Patients received pegcetacoplan 1080 mg subcutaneously twice weekly or continued supportive care (control) for 26 weeks. Coprimary endpoints were hemoglobin stabilization (avoidance of >1-g/dL decrease in hemoglobin levels without transfusions) from baseline through week 26 and lactate dehydrogenase (LDH) change at week 26. Overall, 53 patients received pegcetacoplan (n=35) or control (n=18). Pegcetacoplan was superior to control for hemoglobin stabilization (pegcetacoplan, 85.7%; control, 0; difference, 73.1% [95% CI: 57.2, 89.0]; P <0.0001) and change from baseline in LDH (least-square mean change: pegcetacoplan, -1870.5 U/L; control -400.1 U/L; difference, -1470.4 U/L [95% CI: -2113.4, -827.3]; P <0.0001). Pegcetacoplan was well tolerated. No pegcetacoplan-related adverse events were serious, and no new safety signals observed. Pegcetacoplan rapidly and significantly stabilized hemoglobin and reduced LDH in complement inhibitor-naive patients and had a favorable safety profile. This trial was registered at www.clinicaltrials.gov as #NCT04085601.
PICO Summary
Population
Adult patients with paroxysmal nocturnal haemoglobinuria enrolled in the PRINCE trial conducted in 22 centres in Hong Kong, Malaysia, Philippines, Singapore, Thailand, Colombia, Mexico and Peru (n= 53).
Intervention
Subcutaneous infusions of pegcetacoplan (pegcetacoplan group, n= 35).
Comparison
Supportive care including transfusions, anticoagulants, corticosteroids, and supplements (control group, n= 18).
Outcome
Pegcetacoplan was superior to control for haemoglobin stabilization (pegcetacoplan, 85.7%; control, 0; difference, 73.1%, 95% CI [57.2, 89.0]) and change from baseline in lactate dehydrogenase, (least-square mean change: pegcetacoplan, -1870.5 U/L; control -400.1 U/L; difference, -1470.4 U/L, 95% CI [-2113.4, -827.3]). Pegcetacoplan was well tolerated. No pegcetacoplan-related adverse events were serious, and no new safety signals were observed.
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Effect of red blood cell storage time in pediatric cardiac surgery patients: A subgroup analysis of a randomized controlled trial
Martin, S. M., Tucci, M., Spinella, P. C., Ducruet, T., Fergusson, D. A., Freed, D. H., Lacroix, J., Poirier, N., Sivarajan, V. B., Steiner, M. E., et al
JTCVS open. 2023;15:454-467
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Free full text
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Editor's Choice
Abstract
OBJECTIVE This study aimed to determine whether or not transfusion of fresh red blood cells (RBCs) reduced the incidence of new or progressive multiple organ dysfunction syndrome compared with standard-issue RBCs in pediatric patients undergoing cardiac surgery. METHODS Preplanned secondary analysis of the Age of Blood in Children in Pediatric Intensive Care Unit study, an international randomized controlled trial. This study included children enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial and admitted to a pediatric intensive care unit after cardiac surgery with cardiopulmonary bypass. Patients were randomized to receive either fresh (stored ≤7 days) or standard-issue RBCs. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days postrandomization or at pediatric intensive care unit discharge, or death. RESULTS One hundred seventy-eight patients (median age, 0.6 years; interquartile range, 0.3-2.6 years) were included with 89 patients randomized to the fresh RBCs group (median length of storage, 5 days; interquartile range, 4-6 days) and 89 to the standard-issue RBCs group (median length of storage, 18 days; interquartile range, 13-22 days). There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12 (95% CI, 0.81 to 1.54; P = .49) and an unadjusted absolute risk difference of 5.1% (95% CI, -9.5% to 19.8%; P = .49). CONCLUSIONS In neonates and children undergoing cardiac surgery with cardiopulmonary bypass, the use of fresh RBCs did not reduce the incidence of new or progressive multiple organ dysfunction syndrome compared with the standard-issue RBCs. A larger trial is needed to confirm these results.
PICO Summary
Population
Children admitted to a paediatric intensive care unit after cardiac surgery with cardiopulmonary bypass, enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial (ABC-PICU), (n= 178).
Intervention
Fresh (stored ≤7 days) red blood cells (RBCs), (n= 89).
Comparison
Standard-issue RBCs (n= 89).
Outcome
The authors performed a preplanned subgroup analysis of the ABC-PICU trial. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days post-randomization or at paediatric intensive care unit discharge, or death. There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12; 95% CI [0.81, 1.54] and an unadjusted absolute risk difference of 5.1%; 95% CI [-9.5%, 19.8%].
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A comparative study of stored arterial versus venous blood collected using the acute normovolemic hemodilution method in coronary artery bypass grafting patients in Iran
Mansouri, M., Yazdani, A., Masoumi, G., Mirmohammadsadeghi, M., Mirmohammadsadeghi, A.
Acute and critical care. 2023
Abstract
BACKGROUND In the present study, arterial and venous blood was collected from patients who were candidates for elective coronary artery bypass grafting (CABG); the blood was stored for 28 days and cellular, biomechanical, and hematological changes in blood were compared to determine whether stored arterial blood is superior to stored venous blood. METHODS The present follow-up comparative study included 60 patients >18 years of age, with hemoglobin >14 mg/dl and ejection fraction >40% who were candidates for CABG. After induction of anesthesia, 250 ml of arterial or venous blood was drawn from patients (arterial blood group and venous blood group). Laboratory blood samples were taken at specified times from the collected blood and re-injected into the patients after CABG. RESULTS Significant differences were observed in pH, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2), bicarbonate (HCO3), and glucose values at several time points between the groups. Other parameters such as urea and creatinine did not show any significant differences between the groups. CONCLUSIONS Twenty-eight days of storage can have a negative effect on some of the cellular, biochemical, and hematological components of arterial and venous blood; however, the quality of stored arterial blood and venous blood does not differ significantly.
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Cerebral and intestinal oxygen saturation of different volumes of red blood cell transfusion in preterm infants
Chen, R., Lai, S. H., Xiu, W. L., Cai, W. H., Chen, Z. Q., Xie, Y. L.
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2023;:103839
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Editor's Choice
Abstract
OBJECTIVES The purpose of this study was to investigate and compare the effects of 20 ml/kg and 15 ml/kg red blood cell transfusion (RBCT) on cerebral and intestinal tissue oxygenation, the number of administered transfusions, and neonatal complications in premature infants with anemia. METHODS This prospective, randomized, partially blinded observational study investigated anemic neonates of gestational age < 32 weeks (Registration ID: ChiCTR 1,900,026,672). The infants were randomly assigned to receive 15 or 20 ml/kg red blood cell transfusion. Cerebral and intestinal tissue oxygen saturation (cer rSO(2) and int rSO(2)) were collected 2 h before transfusion, 2, 4, 6, 12, 24, and 48 h after the beginning of transfusion by Near-infrared spectroscopy (NIRS). We also collected vital signs including heart rate (HR), peripheral oxygen saturation (SpO(2)), and mean arterial blood pressure (MABP) 2 h before infusion, 2 h, and 6 h after the beginning of transfusion. Then we analyzed and compared regional oxygen saturation(rSO(2))(,) fractional tissue oxygen extraction (FTOE), and other outcome readouts (blood transfusion numbers, changes in hematocrit and hemoglobin, hospitalization days, HR, SpO2, MABP, and complications) between the two groups. The intraindividual comparisons of the above readouts before transfusion and those after transfusion were also evaluated within each group. RESULT 73 newborns received 20 ml/kg (large volume group) and 78 newborns received 15 ml/kg transfusion (small volume group). There was no significant difference in cer rSO2, int rSO(2), Cerebral fractional tissue oxygen extraction (cFTOE), and intestinal fractional tissue oxygen extraction (iFTOE) between the two groups. rSO(2,) MABP, and SpO(2) increased; HR, cFTOE, and iFTOE decreased following transfusion in both groups. The transfusion number of the large volume group is significantly less than that of the small volume group (1.9 ± 0.3 vs. 2.6 ± 0.9, p < 0.01) and hospitalization days were also less than those in the low volume group (44.3 ± 8.2 vs. 47.6 ± 9.8, p < 0.05). The increases in hematocrit and hemoglobin were higher in the large volume group than those in small volume (hematocrit increment (%),10.7 ± 4.2 vs. 10.1 ± 5.9, p = 0.015; Hb concentration after blood transfusion (g/L) 132.3 ± 11.1 vs. 127.4 ± 15.4, p = 0.028). CONCLUSION After the transfusion, cer rSO2 and int rSO(2) increased significantly, FTOE decreased and vital signs improved in both the 15 ml/kg and 20 ml/kg groups, and these changes were not significantly different between the two groups. However, the larger group showed a more pronounced increase in hematocrit and hemoglobin, a reduction in the total number of transfusions, and a shorter duration of hospitalization after transfusion in preterm infants without increasing complications.
PICO Summary
Population
Premature infants with anaemia (n= 151).
Intervention
15 ml/kg red blood cell transfusion (small volume group, n= 78).
Comparison
20 ml/kg red blood cell transfusion (large volume group, n= 73).
Outcome
There was no significant difference in cerebral tissue oxygen saturation, intestinal tissue oxygen saturation, cerebral fractional tissue oxygen extraction, and intestinal fractional tissue oxygen extraction between the two groups. Regional oxygen saturation, mean arterial blood pressure, and peripheral oxygen saturation increased; heart rate, cerebral fractional tissue oxygen extraction, and intestinal fractional tissue oxygen extraction decreased following transfusion in both groups. The transfusion number of the large volume group was significantly less than that of the small volume group (1.9 ± 0.3 vs. 2.6 ± 0.9) and hospitalization days were also less than those in the low volume group (44.3 ± 8.2 vs. 47.6 ± 9.8,). The increases in haematocrit and haemoglobin were higher in the large volume group than those in small volume (haematocrit increment (%) 10.7 ± 4.2 vs. 10.1 ± 5.9; haemoglobin concentration after blood transfusion (g/L) 132.3 ± 11.1 vs. 127.4 ± 15.4).
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Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia
Carson, J. L., Brooks, M. M., Hébert, P. C., Goodman, S. G., Bertolet, M., Glynn, S. A., Chaitman, B. R., Simon, T., Lopes, R. D., Goldsweig, A. M., et al
The New England journal of medicine. 2023
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Editor's Choice
Abstract
BACKGROUND A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).
PICO Summary
Population
Adult patients with myocardial infarction and anaemia enrolled in the Myocardial Ischemia and Transfusion (MINT) trial (n= 3,504).
Intervention
Restrictive transfusion strategy (haemoglobin cutoff, 7 or 8 g per deciliter), (n= 1,749).
Comparison
Liberal transfusion strategy (haemoglobin cutoff, <10 g per deciliter), (n= 1,755).
Outcome
The primary outcome was a composite of myocardial infarction or death at 30 days. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean haemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1,749 patients (16.9%) in the restrictive-strategy group and in 255 of 1,755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval (CI), [0.99, 1.34]). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI [0.96, 1.47]); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI [0.94, 1.49]).