ABSTRACT
To explore preoperative and operative risk factors for red blood cell (RBC) transfusion requirements during liver transplantation (LT) and up to 24 h afterwards. We evaluated the associations between risk factors and units of RBC transfused in 176 LT patients using a log-binomial regression model. Relative risk was adjusted for age, sex, and the model for end-stage liver disease score (MELD) (adjustment 1) and baseline hemoglobin concentration (adjustment 2). Forty-six patients (26.14%) did not receive transfusion. Grafts from cardiac-death donors were used in 32.61% and 31.54% of non-transfused and transfused patients, respectively. The transfused group required more reoperation for bleeding (P = 0.035), longer mechanical ventilation after LT (P < 0.001), and longer ICU length of stay (P < 0.001). MELD and hemoglobin concentrations determined RBC requirements. For each unit of increase in the MELD score, 2% more RBC units were transfused, and non-transfusion was 0.83-fold less likely. For each 10-g/L higher hemoglobin concentration at baseline, 16% less RBC transfused, and non-transfusion was 1.95-fold more likely. Ascites was associated with 26% more RBC transfusions. With an increase of 2 mm from the baseline in the A10FIBTEM measurement of maximum clot firmness, non-transfusion was 1.14-fold more likely. A 10-min longer cold ischemia time was associated with 1% more RBC units transfused, and the presence of post-reperfusion syndrome with 45% more RBC units. We conclude that preoperative correction of anemia should be included in LT. An intervention to prevent severe hypotension and fibrinolysis during graft reperfusion should be explored.Trial register: European Clinical Trials Database (EudraCT 2018-002,510-13) and ClinicalTrials.gov (NCT01539057).
Subject(s)
Liver Transplantation , Aged , Female , Humans , Male , Middle Aged , Blood Transfusion , End Stage Liver Disease/surgery , Erythrocyte Transfusion , Hemoglobins/metabolism , Hemoglobins/analysis , Length of Stay , Liver Transplantation/adverse effects , Liver Transplantation/methods , Risk FactorsABSTRACT
BACKGROUND: Preterm infants are at high risk for retinopathy of prematurity (ROP), with potential life-long visual impairment. Low fetal hemoglobin (HbF) levels predict ROP. It is unknown if preventing the HbF decrease also reduces ROP. METHODS: BORN is an ongoing multicenter double-blinded randomized controlled trial investigating whether transfusing HbF-enriched cord blood-red blood cells (CB-RBCs) instead of adult donor-RBC units (A-RBCs) reduces the incidence of severe ROP (NCT05100212). Neonates born between 24 and 27 + 6 weeks of gestation are enrolled and randomized 1:1 to receive adult donor-RBCs (A-RBCs, arm A) or allogeneic CB-RBCs (arm B) from birth to the postmenstrual age (PMA) of 31 + 6 weeks. Primary outcome is the rate of severe ROP at 40 weeks of PMA or discharge, with a sample size of 146 patients. A prespecified interim analysis was scheduled after the first 58 patients were enrolled, with the main purpose to evaluate the safety of CB-RBC transfusions. RESULTS: Results in the intention-to-treat and per-protocol analysis are reported. Twenty-eight patients were in arm A and 30 in arm B. Overall, 104 A-RBC units and 49 CB-RBC units were transfused, with a high rate of protocol deviations. A total of 336 adverse events were recorded, with similar incidence and severity in the two arms. By per-protocol analysis, patients receiving A-RBCs or both RBC types experienced more adverse events than non-transfused patients or those transfused exclusively with CB-RBCs, and suffered from more severe forms of bradycardia, pulmonary hypertension, and hemodynamically significant patent ductus arteriosus. Serum potassium, lactate, and pH were similar after CB-RBCs or A-RBCs. Fourteen patients died and 44 were evaluated for ROP. Ten of them developed severe ROP, with no differences between arms. At per-protocol analysis each A-RBC transfusion carried a relative risk for severe ROP of 1.66 (95% CI 1.06-2.20) in comparison with CB-RBCs. The area under the curve of HbF suggested that HbF decrement before 30 weeks PMA is critical for severe ROP development. Subsequent CB-RBC transfusions do not lessen the ROP risk. CONCLUSIONS: The interim analysis shows that CB-RBC transfusion strategy in preterm neonates is safe and, if early adopted, might protect them from severe ROP. TRIAL REGISTRATION: Prospectively registered at ClinicalTrials.gov on October 29, 2021. Identifier number NCT05100212.
Subject(s)
Fetal Blood , Retinopathy of Prematurity , Humans , Retinopathy of Prematurity/prevention & control , Infant, Newborn , Female , Male , Double-Blind Method , Erythrocyte Transfusion , Infant, Extremely Premature , Gestational Age , Treatment Outcome , Severity of Illness IndexABSTRACT
BACKGROUND: Packed red blood cell (pRBC) transfusion is a relatively safe and mainstay treatment commonly used in cardiac surgical patients. However, there is limited evidence on clinical effects of transfusing blood nearing end-of shelf life that has undergone biochemical changes during storage. OBJECTIVE: To investigate evidence of associations between morbidity/mortality and transfusion of blood near end of shelf-life (> 35 days) in cardiac surgical patients. METHODS: Data from the Queensland Health Admitted Patient Data Collection database 2007-2013 was retrospectively analysed. Coronary artery bypass graft and valvular repair patients were included. Multivariable logistic regression was used to examine the effect of pRBC age (< 35 days vs. ≥ 35 days) on in-hospital mortality and morbidity. As secondary analysis, outcomes associated with the number of pRBC units transfused (≤ 4 units vs. ≥ 5 units) were also assessed. RESULTS: A total of 4514 cardiac surgery patients received pRBC transfusion. Of these, 292 (6.5%) received pRBCs ≥ 35 days. No difference in in-hospital mortality or frequency of complications was observed. Transfusion of ≥ 5 units of pRBCs compared to the ≤ 4 units was associated with higher rates of in-hospital mortality (5.6% vs. 1.3%), acute renal failure (17.6% vs. 8%), infection (10% vs. 3.4%), and acute myocardial infarction (9.2% vs. 4.3%). Infection carried an odds ratio of 1.37 between groups (CI = 0.9-2.09; p = 0.14) and stroke/neurological complications, 1.59 (CI = 0.96-2.63; p = 0.07). CONCLUSION: In cardiac surgery patients, transfusion of pRBCs closer to end of shelf-life was not shown to be associated with significantly increased mortality or morbidity. Dose-dependent differences in adverse outcomes (particularly where units transfused were > 4) were supported.
Subject(s)
Cardiac Surgical Procedures , Erythrocyte Transfusion , Hospital Mortality , Humans , Retrospective Studies , Male , Female , Aged , Queensland/epidemiology , Middle Aged , Postoperative Complications/epidemiologyABSTRACT
Surgical patients are often transfused to manage bleeding and anemia. Best practices for red blood cell (RBC) transfusion administration in patient having noncardiac surgery remains controversial and a robust evaluation and description of perioperative transfusion practices is lacking. We characterized perioperative hemoglobin concentrations and transfusion practices from the prospective VISION cohort which included 39,222 patients aged ≥45 years who had inpatient noncardiac surgery. Variations in transfusion practices were analyzed using hierarchical mixed models, and associations with mortality and complications were evaluated using a nested frailty survival model. Within the cohort, 16.1% (nâ¯=â¯6296) were given perioperative RBC transfusions, with the fraction declining from 20% to 13% over the 6-year study period. The proportion of patients transfused varied by surgery type from 6.4% for low-risk operations (i.e., minor surgery) to 31.5% for orthopedic surgeries. Variations were largely associated with patient hemoglobin concentrations, but also with center (range: 3.7%-27.3%) and country (0.4%-25.3%). Even after adjusting for baseline hemoglobin, comorbidities and type of surgery, both center and country were significant sources of variation in transfusion practices. Among transfused participants, 60.4% (nâ¯=â¯3728/6170) had at least 1 hemoglobin concentration ≤80g/L and 86.0% (nâ¯=â¯5305/6170) had at least 1 hemoglobin concentration ≤90g/L, suggesting that relatively restrictive transfusion strategies were used in most. The proportion of patients receiving at least 1 RBC transfusion declined from 20% to 13% over 6 years. However, there was considerable unexplained variation in transfusion practices.
Subject(s)
Anemia , Erythrocyte Transfusion , Hemoglobins , Perioperative Care , Humans , Middle Aged , Female , Male , Aged , Erythrocyte Transfusion/statistics & numerical data , Perioperative Care/methods , Perioperative Care/statistics & numerical data , Hemoglobins/analysis , Anemia/therapy , Anemia/epidemiology , Prospective Studies , Surgical Procedures, Operative/statistics & numerical data , Surgical Procedures, Operative/adverse effects , Blood Transfusion/statistics & numerical data , Blood Transfusion/methodsABSTRACT
BACKGROUND Post-transfusion purpura (PTP) is a rare delayed adverse event characterized by severe thrombocytopenia associated with mucosal bleeding and purpura. PTP is associated with the development of alloantibodies to human platelet antigens (HPAs) and should be distinguished from other thrombocytopenic syndromes. This report is of a 69-year-old man with refractory cardiogenic shock and thrombocytopenia 4 days following blood transfusion, diagnosed with post-transfusion purpura. CASE REPORT A 69-year-old man was admitted to a tertiary medical center with refractory cardiogenic shock. Four days after he received 1 unit of packed red blood cells, his platelet count plummeted from 147 K/uL to <2 K/uL within hours, associated with delayed presentation of notable hematuria and femoral catheter oozing. An extensive thrombocytopenia work-up, including an initial platelet antibody screen, was unrevealing. The patient was treated with supportive transfusions, dexamethasone, and intravenous immunoglobulin, with rapid platelet recovery. Post-transfusion purpura panel testing later identified anti-human platelet antigen-5b antibodies, confirming the diagnosis. CONCLUSIONS This report presents an unusual course and presentation of post-transfusion purpura in an elderly man. Unusual features of this case include male sex, hyper-acuity of thrombocytopenia, lack of prior transfusions, exam findings, identification of a less common alloantibody, and negative initial platelet antigen screening. This report highlights the importance of monitoring patients for post-transfusion adverse events. Although PTP is rare, rapid diagnosis and management are required to control this potentially life-threatening condition.
Subject(s)
Isoantibodies , Humans , Male , Aged , Isoantibodies/immunology , Transfusion Reaction/diagnosis , Transfusion Reaction/immunology , Purpura/etiology , Shock, Cardiogenic/etiology , Erythrocyte Transfusion/adverse effectsABSTRACT
Introduction: Decreasing rates of blood donation and close margins between blood supply and demand pose challenges in healthcare. Genetically engineered pig red blood cells (pRBCs) have been explored as alternatives to human RBCs for transfusion, and triple-gene knockout (TKO) modification improves the compatibility of pRBCs with human blood in vitro. In this study, we assessed the efficacy and risks of transfusing wild-type (WT)- and TKO-pRBCs into nonhuman primates (NHPs). Methods: Blood from O-type WT and TKO pigs was processed to produce pRBCs for transfusion, which were transfused or not into NHPs (n=4 per group: WT, TKO, and control) after 25% total blood volume withdrawal: their biological responses were compared. Hematological, biochemical, and immunological parameters were measured before, immediately after, and at intervals following transfusion. Two months later, a second transfusion was performed in three NHPs of the transfusion group. Results: Transfusion of both WT- and TKO-pRBCs significantly improved RBC counts, hematocrit, and hemoglobin levels up to the first day post-transfusion, compared to the controls. The transfusion groups showed instant complement activation and rapid elicitation of anti-pig antibodies, as well as elevated liver enzyme and bilirubin levels post-transfusion. Despite the higher agglutination titers with WT-pRBCs in the pre-transfusion crossmatch, the differences between the WT and TKO groups were not remarkable except for less impairment of liver function in the TKO group. After the second transfusion, more pronounced adverse responses without any hematological gain were observed. Conclusions: WT- and TKO-pRBC transfusions effectively increased hematologic parameters on the first day, with rapid clearance from circulation thereafter. However, pRBC transfusion triggers strong antibody responses, limiting the benefits of the pRBC transfusion and increasing the risk of adverse reactions.
Subject(s)
Erythrocyte Transfusion , Erythrocytes , Gene Knockout Techniques , Animals , Erythrocyte Transfusion/adverse effects , Erythrocyte Transfusion/methods , Swine , Erythrocytes/immunology , Erythrocytes/metabolism , Animals, Genetically Modified , Hemoglobins/metabolism , Galactosyltransferases/genetics , Galactosyltransferases/deficiency , Hematocrit , Female , Male , PrimatesABSTRACT
BACKGROUND: The data to support chronic automated red cell exchange (RCE) in sickle cell disease (SCD) outside of stroke prevention, is limited, especially in adults. STUDY DESIGN AND METHODS: A retrospective analysis was conducted of patients with SCD who were referred for chronic RCE at our institution over a 10-year period. Data that were evaluated included patient demographics, referral indications, and procedural details (e.g., vascular access, adverse events, etc.). In a subanalysis, the number of annual acute care encounters during 3 years of chronic RCE was compared with that in the year preceding the first RCE. RESULTS: A total of 164 patients were referred for chronic RCE: median age was 28 years (interquartile range [IQR] = 22-36) at referral and 60% were female. Seventy (42.6%) were naïve to chronic transfusion (simple or RCE) prior to referral. The leading indications for referral were refractory pain (73/164, 44.5%) and iron overload (57/164, 34.7%). A total of 5090 procedures occurred during the study period (median = 19, IQR = 5-45). Of the 138 patients who had central vascular access, 8 (6%) and 16 (12%) had ≥1 central-line-related thrombosis and/or infection, respectively. Of those who were not RBC alloimmunized at initiation of RCE, 12/105 (11.4%) developed new antibodies during chronic RCE. In those 30 patients who were adherent to therapy for 3 years, there was no significant difference in acute care encounters following initiation of RCE. CONCLUSION: Prospective clinical trials are needed to determine which patients are most likely to benefit from chronic RCE and refine selection accordingly.
Subject(s)
Anemia, Sickle Cell , Erythrocyte Transfusion , Humans , Anemia, Sickle Cell/therapy , Female , Male , Retrospective Studies , Adult , Young AdultABSTRACT
BACKGROUND: Within the neonatal intensive care unit (NICU), infants frequently receive packed red blood cell (PRBC) transfusions. Although medically necessary, potential negative long- and short-term outcomes exist following PRBC transfusions in very low birth-weight (VLBW) infants (<1500 g). Synthesis of the literature demonstrates that the use of a restrictive PRBC transfusion policy can lead to a decreased number of transfusions administered with no increase in long-term neurodevelopmental outcomes. Blood transfusions have also been linked to the diagnosis of necrotizing enterocolitis (NEC) or intraventricular hemorrhage (IVH) in VLBW infants. PURPOSE: For this quality improvement project, a restrictive PRBC transfusion policy was implemented in a level IV NICU to promote consistent care and evaluate changes in PRBC administration. METHODS: The data were collected both pre- and post-policy implementation including: the number of blood transfusions, diagnosis of NEC, and diagnosis of IVH among infants <1500 g. RESULTS: The data showed no significant change in the number of PRBC transfusions administered. Likewise, few infants were diagnosed with NEC or IVH during this same time period with minimal change between pre- and post-policy implementation data. IMPLICATIONS FOR PRACTICE AND RESEARCH: Following policy implementation, there was a significant improvement in communication among providers regarding transfusion ordering and the inclusion of hematocrit thresholds in daily progress notes. This unintended outcome has helped to promote sustainability and enhance patient care within the NICU where this policy was implemented. Continued data collection may be beneficial in indicating whether a standardized PRBC transfusion policy will impact the administration of transfusions and diagnosis of NEC or IVH.
Subject(s)
Enterocolitis, Necrotizing , Erythrocyte Transfusion , Infant, Very Low Birth Weight , Intensive Care Units, Neonatal , Quality Improvement , Humans , Erythrocyte Transfusion/methods , Erythrocyte Transfusion/standards , Infant, Newborn , Intensive Care Units, Neonatal/standards , Infant, Premature , Female , MaleABSTRACT
Despite recent advances in surgical techniques and perinatal management in obstetrics for reducing intraoperative bleeding, blood transfusion may occur during a cesarean section (CS). This study aims to identify machine learning models with an optimal diagnostic performance for intraoperative transfusion prediction in parturients undergoing a CS. Additionally, to address model performance degradation due to data imbalance, this study further investigated the variation in predictive model performance depending on the ratio of event to non-event data (1:1, 1:2, 1:3, and 1:4 model datasets and raw data).The area under the receiver operating characteristic curve (AUROC) and area under the precision-recall curve (AUPRC) were evaluated to compare the predictive accuracy of different machine learning algorithms, including XGBoost, K-nearest neighbor, decision tree, support vector machine, multilayer perceptron, logistic regression, random forest, and deep neural network. We compared the predictive performance of eight prediction algorithms that were applied to five types of datasets. The intraoperative transfusion in maternal CS was 7.2% (1020/14,254). XGBoost showed the highest AUROC (0.8257) and AUPRC (0.4825) among the models. The most significant predictors for transfusion in maternal CS as per machine learning models were placenta previa totalis, haemoglobin, placenta previa partialis, and platelets. In all eight prediction algorithms, the change in predictive performance based on the AUROC and AUPRC according to the resampling ratio was insignificant. The XGBoost algorithm exhibited optimal performance for predicting intraoperative transfusion. Data balancing techniques employed to alter the event data composition ratio of the training data failed to improve the performance of the prediction model.
Subject(s)
Cesarean Section , Erythrocyte Transfusion , Machine Learning , Humans , Cesarean Section/adverse effects , Female , Pregnancy , Erythrocyte Transfusion/methods , Adult , ROC Curve , Algorithms , Blood Loss, Surgical/prevention & controlABSTRACT
BACKGROUND AND OBJECTIVES: Packed red blood cell transfusions (pRBCT) in preterm infants have been associated with significant morbidity. Although infants <26 weeks' gestational age typically require several pRBCT, preterm infants born between 26 and 34 weeks' gestational age may also require pRBCT during their hospitalization that are potentially preventable. We aimed to reduce pRBCT in this population by 20%. METHODS: This quality improvement project was conducted in the Duke University Hospital NICU between July 2018 and February 2023. Interventions included the implementation of evidence-based transfusion thresholds, supporting bone marrow erythropoiesis, and reducing laboratory specimen volumes by increasing capillary test panels. The rates per 1000 patient days for pRBCT (outcome measure), number of new patients initiated on erythropoietin (process measure), number of basic metabolic panels (process measure), and total capillary panels (process measure) were monitored during the project period. Statistical process control charts were used to observe trends over time. RESULTS: Among infants born between 26 0/7 and 34 6/7 weeks' gestational age, the rate of pRBCT decreased from an average of 23.8 to 12.7 transfusions per 1000 patient days, which is a 46.6% decrease. Increases in the use of erythropoietin and capillary panels were observed, along with a decrease in the use of basic metabolic panels. There was no change in mortality or the rate of necrotizing enterocolitis. Improvement was sustained for 24 months after implementation. CONCLUSIONS: pRBCT can be decreased in preterm infants born between 26 and 34 completed weeks' gestation through a combination of strategies utilizing quality improvement methodology.
Subject(s)
Erythrocyte Transfusion , Infant, Premature , Quality Improvement , Humans , Infant, Newborn , Erythropoietin/therapeutic use , Intensive Care Units, Neonatal , Female , Male , Gestational Age , Anemia, Neonatal/therapy , Anemia, Neonatal/prevention & controlABSTRACT
Recent years have seen increased discussion surrounding the benefits of damage control resuscitation, prehospital transfusion (PHT) of blood products, and the use of whole blood over component therapy. Concurrent shortages of blood products with the desire to provide PHT during air medical transport have prompted reconsideration of the traditional approach of administering RhD-negative red cell-containing blood products first-line to females of childbearing potential (FCPs). Given that only 7% of the US population has blood type O negative and 38% has O positive, some programs may be limited to offering RhD-positive blood products to FCPs. Adopting the practice of giving RhD-positive blood products first-line to FCPs extends the benefits of PHT to such patients, but this practice does incur the risk of future hemolytic disease of the fetus and newborn (HDFN). Although the risk of future fetal mortality after an RhD-incompatible transfusion is estimated to be low in the setting of acute hemorrhage, the number of FCPs who are affected by this disease will increase as more air medical transport programs adopt this practice. The process of monitoring and managing HDFN can also be time intensive and costly regardless of the rates of fetal mortality. Air medical transport programs planning on performing PHT of RhD-positive red cell-containing products to FCPs should have a basic understanding of the pathophysiology, prevention, and management of hemolytic disease of the newborn before introducing this practice. Programs should additionally ensure there is a reliable process to notify receiving centers of potentially RhD-incompatible PHT because alloimmunization prophylaxis is time sensitive. Facilities receiving patients who have had PHT must be prepared to identify, counsel, and offer alloimmunization prophylaxis to these patients. This review aims to provide air medical transport professionals with an understanding of the pathophysiology and management of HDFN and provide a template for the early management of FCPs who have received an RhD-positive red cell-containing PHT. This review also covers the initial workup and long-term anticipatory guidance that receiving trauma centers must provide to FCPs who have received RhD-positive red cell-containing PHT.
Subject(s)
Air Ambulances , Rh-Hr Blood-Group System , Humans , Female , Pregnancy , Erythrocyte Transfusion/methods , Erythroblastosis, Fetal/therapy , AdultABSTRACT
Haemoglobin (Hb) thresholds and red blood cells (RBC) transfusion strategies in traumatic brain injury (TBI) are controversial. Our objective was to assess the association of Hb values with long-term outcomes in critically ill TBI patients. We conducted a secondary analysis of CENTER-TBI, a large multicentre, prospective, observational study of European TBI patients. All patients admitted to the Intensive Care Unit (ICU) with available haemoglobin data on admission and during the first week were included. During the first seven days, daily lowest haemoglobin values were considered either a continous variable or categorised as < 7.5 g/dL, between 7.5-9.5 and > 9.5 g/dL. Anaemia was defined as haemoglobin value < 9.5 g/dL. Transfusion practices were described as "restrictive" or "liberal" based on haemoglobin values before transfusion (e.g. < 7.5 g/dL or 7.5-9.5 g/dL). Our primary outcome was the Glasgow outcome scale extended (GOSE) at six months, defined as being unfavourable when < 5. Of 1590 included, 1231 had haemoglobin values available on admission. A mean Injury Severity Score (ISS) of 33 (SD 16), isolated TBI in 502 (40.7%) and a mean Hb value at ICU admission of 12.6 (SD 2.2) g/dL was observed. 121 (9.8%) patients had Hb < 9.5 g/dL, of whom 15 (1.2%) had Hb < 7.5 g/dL. 292 (18.4%) received at least one RBC transfusion with a median haemoglobin value before transfusion of 8.4 (IQR 7.7-8.5) g/dL. Considerable heterogeneity regarding threshold transfusion was observed among centres. In the multivariable logistic regression analysis, the increase of haemoglobin value was independently associated with the decrease in the occurrence of unfavourable neurological outcomes (OR 0.78; 95% CI 0.70-0.87). Congruous results were observed in patients with the lowest haemoglobin values within the first 7 days < 7.5 g/dL (OR 2.09; 95% CI 1.15-3.81) and those between 7.5 and 9.5 g/dL (OR 1.61; 95% CI 1.07-2.42) compared to haemoglobin values > 9.5 g/dL. Results were consistent when considering mortality at 6 months as an outcome. The increase of hemoglobin value was associated with the decrease of mortality (OR 0.88; 95% CI 0.76-1.00); haemoglobin values less than 7.5 g/dL was associated with an increase of mortality (OR 3.21; 95% CI 1.59-6.49). Anaemia was independently associated with long-term unfavourable neurological outcomes and mortality in critically ill TBI patients.Trial registration: CENTER-TBI is registered at ClinicalTrials.gov, NCT02210221, last update 2022-11-07.
Subject(s)
Blood Transfusion , Brain Injuries, Traumatic , Critical Illness , Hemoglobins , Intensive Care Units , Humans , Brain Injuries, Traumatic/therapy , Brain Injuries, Traumatic/blood , Brain Injuries, Traumatic/mortality , Brain Injuries, Traumatic/complications , Male , Female , Middle Aged , Hemoglobins/analysis , Prospective Studies , Critical Illness/therapy , Adult , Intensive Care Units/organization & administration , Intensive Care Units/statistics & numerical data , Blood Transfusion/methods , Blood Transfusion/statistics & numerical data , Aged , Anemia/therapy , Anemia/blood , Treatment Outcome , Glasgow Outcome Scale , Erythrocyte Transfusion/methods , Erythrocyte Transfusion/statistics & numerical dataABSTRACT
INTRODUCTION: Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk. METHODS AND ANALYSIS: A pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention. ETHICS AND DISSEMINATION: Institutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: NCT04803747.
Subject(s)
Antifibrinolytic Agents , Tranexamic Acid , Humans , Antifibrinolytic Agents/therapeutic use , Antifibrinolytic Agents/administration & dosage , Blood Loss, Surgical/prevention & control , Canada , Cross-Over Studies , Erythrocyte Transfusion , Organizational Policy , Tranexamic Acid/therapeutic use , Tranexamic Acid/administration & dosage , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).
Subject(s)
Anemia , Brain Injuries, Traumatic , Erythrocyte Transfusion , Adult , Aged , Female , Humans , Male , Middle Aged , Anemia/blood , Anemia/etiology , Anemia/therapy , Brain Injuries, Traumatic/blood , Brain Injuries, Traumatic/complications , Brain Injuries, Traumatic/diagnosis , Brain Injuries, Traumatic/therapy , Critical Illness , Depression/etiology , Erythrocyte Transfusion/adverse effects , Erythrocyte Transfusion/methods , Glasgow Outcome Scale , Hemoglobins/analysis , Quality of LifeABSTRACT
BACKGROUND: The aim of this retrospective and observational study was to analyse the impact of the introduction of a goal directed transfusion (GDT) strategy based on a viscoelastic test (ROTEM®) and specific procoagulant products in a patient blood management (PBM) Program on blood product use and perioperative bleeding in a single cardiac surgery centre. STUDY DESIGN AND METHODS: Patient population underwent cardiac surgery from 2011 to 2021 was divided in two groups based on PBM protocol used (G#11-14, years 2011-2014, G#15-21, years 2015-2021) and compared for the following variables: intraoperative and postoperative transfusions of packed red blood cell and any procoagulant products, postoperative drain blood loss volume and rate of re-exploration surgery. The second program was defined after the introduction of a GDT protocol based on viscoelastic tests and specific procoagulant products. RESULTS: After the introduction of a GDT protocol, about 80% less amongst patients were transfused with fresh frozen plasma and any procoagulant product (p < 0.001 for both phases). Moreover, similar results were obtained with PRBC transfusions (p < 0.001) and drain blood loss volume (p = 0.006) in the postoperative phase. The main factors affecting the use of any procoagulant and PBRC transfusion in the multivariate logistic regression analysis was Group (2 versus 1, OR 0.207, p < 0.001) and preoperative haemoglobin (OR 0.728, p < 0.001), respectively. DISCUSSION: In our experience, a GDT strategy for the diagnosis and treatment of the coagulopathy in patients undergone cardiac surgery led to a significant reduction in bleeding and transfusion.
Subject(s)
Cardiac Surgical Procedures , Humans , Male , Female , Retrospective Studies , Aged , Middle Aged , Blood Transfusion , Blood Loss, Surgical/prevention & control , Thrombelastography , Erythrocyte TransfusionABSTRACT
OBJECTIVE: To describe the clinical burden and healthcare resource utilization associated with managing transfusion-dependent ß-thalassemia (TDT) in France. METHODS: We used the French National Health Data System (système national des données de santé) to identify eligible patients from January 1, 2012, to March 1, 2019. Inclusion criteria were a diagnosis of ß-thalassemia, ≥8 red blood cell (RBC) transfusion episodes per year in ≥2 consecutive years following the diagnosis, and ≥1 year of follow-up data. Patients were excluded if medical records showed evidence of sickle cell disease, α-thalassemia, hereditary persistence of fetal hemoglobin, or hematopoietic stem cell transplant. Clinical complications, mortality, treatment use, and healthcare resource utilization were evaluated. RESULTS: Overall, 331 eligible patients with TDT were identified. Mean age was 26.1 (standard deviation [SD]: 18.0) years, and 50.5% were male. Common clinical complications were endocrine (26.0%), hepatobiliary (22.7%), and cardiopulmonary (18.7%). Fifteen (4.5%) patients died during follow-up, with a mortality rate of 1.16 deaths per 100 person-years (mean age of death: 52.5 years [SD: 22]). Patients had a mean of 13.5 (SD: 5.2) RBC transfusion episodes and 11.2 (SD: 5.3) iron chelation therapy treatments per year. Healthcare resource utilization was substantial, with a mean of 14.8 inpatient hospitalizations (including 13.8 mean inpatient day cases) and 16.9 outpatient prescriptions per patient per year. CONCLUSIONS: Patients with TDT in France experience significant clinical complications, elevated mortality, and substantial healthcare resource utilization driven by frequent RBC transfusion episodes and inpatient hospitalizations. These results reinforce the need for disease-modifying therapies for this patient population.