Transfusion-related Adverse Events Research Articles

Transfusion-Associated Reversible Cerebral Vasoconstriction Syndrome in Pediatrics: A Case Report and Review of Literature

Background Reversible cerebral vasoconstriction syndrome (RCVS) is a rare complication of packed red blood cell (pRBC) transfusion primarily reported in adults with severe chronic anemia due to menorrhagia. It is characterized by a triad of rapidly changing and reversible segmental cerebral artery narrowing and dilatation, thunderclap headache, and benign cerebrospinal fluid findings. 1,2 More than 50% of patients experience blurring of vision or cortical vision loss, and a subset of patients develop hemiparesis or aphasia. 1 There are emerging case reports of RCVS in pediatric patients, however the literature examining this transfusion complication in children is limited. The rarity and potential severity of RCVS warrants better understanding by pediatric hematology and transfusion providers. Results We describe a previously healthy 4 year-old male who presented with pallor and laboratory parameters consistent with severe iron deficiency anemia. Chest x-ray showed cardiomegaly, and echocardiogram demonstrated pericardial effusion, moderate left ventricular dilation, and moderate coronary artery dilatation. His history was notable for an extremely selective diet and at least 50 ounces of cow's milk daily. The patient was admitted, and over the course of 3 days, he received a total of 43 mL/kg of pRBCs (602 mL total) in 8 aliquots, and his hemoglobin (Hgb) increased from 1.4 g/dL to 11.4 g/dL (Fig. 1). He then re-presented 5 days after discharge with altered mental status and malignant hypertension. Brain MRI/MRA was consistent with RCVS, with luminal irregularities in multiple anterior and posterior circulation intracranial arteries creating a beaded appearance. He was treated supportively with aggressive blood pressure control and made a complete neurologic recovery 8 days after presentation. At hematology clinic follow-up 2 months post-discharge, he remained at his typical neurologic baseline. Conclusions The connection between blood transfusion and RCVS is postulated to be due to a rapid increase in hematocrit and blood viscosity, which alters cerebral autoregulation and leads to hypertensive encephalopathy despite systemic normotension. 3 The increased viscosity may also lead to vasospasm. 3 When a patient with severe chronic anemia receives a pRBC transfusion, there is increased cerebral blood flow and viscosity, resulting in decreased vasodilation, increased vascular resistance, and cerebral vessel constriction. However, these are hypothesized mechanisms with little supportive experimental data. Vasculopathies and vasoconstrictive medications 2 are also risk factors for RCVS. There are 4 previous reported cases of pediatric RCVS associated with pRBC transfusion. 2 patients were acutely ill with complications of sickle cell anemia. 7,9 Another case occurred in a patient with systemic lupus erythematosus 8, and the fourth occurred in the setting of severe iron deficiency anemia. 5 Several features of our patient's clinical course are similar to the reported cases of transfusion-related RCVS 5 and warrant highlighting: 1) severe chronic anemia with cardiac dysfunction and 2) the large volume of transfused pRBCs over a short period resulting in a significant increase in Hgb. However, our patient developed symptoms of RCVS sooner than other published cases and did not have seizure or stroke. Pediatric guidelines recommend pRBC transfusion for Hgb levels between 5-10 g/dL, depending on the clinical scenario. 4 There are few data to guide Hgb targets for pediatric patients presenting with severe anemia. Over-transfusion does not offer physiological benefit and poses risk of transfusion-related adverse events. A case report from Dou et al 6 proposed that a >5 g/dL Hgb increase was associated with a greater likelihood of developing RCVS. For this patient with cardiac dysfunction and social concerns including lack of primary care, the potential benefits of achieving a higher Hgb with pRBC transfusions were prioritized. RCVS should be considered in pediatric and adult patients recently transfused for chronic severe anemia presenting with headaches or other neurological symptoms. Prompt recognition of RCVS may prevent unnecessary treatment and potentially limit risk of neurologic compromise. The role of the volume and rapidity of the pRBC transfusions in the development of RCVS warrants further study. Fig 1. Timeline of initial presentation, detailing blood transfusions

82 Management of Very Severe Iron Deficiency Anemia: Is Transfusion Always Necessary?

Abstract Background Paediatric iron deficiency anemia (IDA) is a common condition in Canadian children; however, little is known about the natural history of extreme cases. This deficit makes it challenging to determine how to approach management when these patients present acutely to the emergency department (ED). Objectives To describe the clinical features and management of children presenting to the ED with very severe IDA with hemoglobin < 40 g/L. Design/Methods Retrospective chart reviews were performed for paediatric patients with IDA and hemoglobin < 40 g/L over a 5-year period (June 2017 – June 2022) at a Canadian tertiary care children’s hospital. Results Chart reviews were completed for 19 patients. The mean case rate was 3.1 patients annually (SD 2.14) with 11(58%) presenting in 2021–2022. Patients were young (median age 24 months; IQR 18–32) and predominantly female (79%). Nutritional deficiencies were the most common etiology (n=16, 84%). Median presenting hemoglobin was 25 g/L (IQR 22–36 g/L). The most common clinical features documented at presentation were pallor (n=19, 100%), tachycardia (n=17, 89%), and systolic ejection murmur (n=14, 74%). Thirteen (68%) patients had a ferritin measured in ED, 11(58%) had a chest x-ray, four (21%) had a lactate measured. One (5%) patient had an echocardiogram, and four (21%) had bedside cardiac ultrasounds documented. Eight (42%) patients with median hemoglobin 35 g/L (IQR 25–36 g/L) were managed without blood transfusion (PO iron only: n=3, 16%; IV iron only: n=5, 26%). Of the 11 (63%) patients who received blood, 2 (18%) had transfusion-related adverse events, with one patient undergoing intubation for transfusion-associated circulatory overload while admitted. All patients (100%) were initiated on oral iron supplementation. Ten patients (53%) received intravenous (IV) iron (dose 5–7 mg/kg) with one experiencing a mild reaction. Fifteen patients (79%) were hospitalized, with two (10%) admitted directly to the Paediatric Intensive Care Unit. Median duration of hospitalization was 5 days (IQR 2–9 days). Patients followed after transfusion-free management (n=5) demonstrated median hemoglobin increase of 21 g/L (IQR 20–32 g/L) within 12 days. No patient returned to the ED for anemia within 30 days. Conclusion Paediatric patients with very severe IDA do not always require transfusion. Some patients were effectively managed with IV iron alone. Investigation and management of these patients appears heterogenous. Given the risks of blood transfusion and the increased availability of IV iron, guidelines outlining evidence-based management of severe IDA are needed. These guidelines should promote optimization of iron therapy and guide judicious administration of blood transfusion.

Retrospective study of canine blood xenotransfusion compared with type-matched feline blood allotransfusion to cats: indications, effectiveness, limitations and adverse effects.

Xenotransfusion is the transfusion of blood from one species to another. With varying availability of allogenic feline blood (AFB) and in emergency conditions, circumstances occur when canine blood is transfused to cats. This study aimed to characterise the indications, effectiveness, limitations, and acute and late transfusion-related adverse effects of canine blood xenotransfusion compared with matched AFB to anaemic cats, and their survival and longer-term outcome. This retrospective study (2013-2020) examined cats receiving canine blood xenotransfusions or AFB. The study included 311 cats (xenotransfusion [X-group], n = 105; allotransfusion [A-group], n = 206). Xenotransfusion was more frequent among cats sustaining haemorrhage than in those with haemolysis (P <0.01) or hypoproliferative anaemia (P <0.001). Financial constraints were the most common reason to elect xenotransfusion (49%). The post-transfusion mean packed cell volume was higher (P <0.001) in the X-group (22%) compared with the A-group (18%), and also higher (P <0.001) at 48-96 h post-transfusion (23% vs 18%, respectively). Transfusion-related adverse effects (TRAEs) were more frequent (P = 0.001) in the X-group (37.1%) compared with the A-group (19.4%), as were delayed haemolytic transfusion reactions (85% vs 42.5%, respectively; P <0.001). Acute transfusion reactions (ATRs) were more frequent (P <0.001) in the A-group (60%) compared with the X-group (20%). TRAEs were unassociated with survival to discharge. The survival to discharge rate of the X-group (55%) was lower (P = 0.007) than in the A-group (73%), while post-discharge survival rates to 30 days of cats surviving to discharge were 90% and 88%, respectively (P = 0.85). Canine blood xenotransfusions to cats might save lives in emergency conditions when AFB is unavailable or blood typing is infeasible. The survival to discharge rate of the X-group was lower than that of the A-group. The longer-term survival rate of cats administered xenotransfusions and surviving to discharge from the hospital was good.

Prevalence and factors associated to transfusion adverse reactions at the Sourou Sanou University Hospital of Bobo-Dioulasso between January and December 2019

Introduction: Blood transfusions save thousands of lives every day all around the world. They can, however, cause severe adverses reactions in transfused patients, which can be fatal. Our study's goal was to estimate the incidence of transfusion related adverse events and to identify the factors that contribute to the occurrence of transfusion reactions in transfused patients. Methods: Between January and December 2019, we conducted a cross-sectional study at the clinical departments of Sourou Sanou University Hospital (CHU-SS). Results: Transfusion responses occurred at a rate of 29.91 per 1000 blood bags transfused, with 39.13% being infectious and 13.04% being allergic. Transfusion reactions were 3.54 times (p = 0.05) and 4.16 times (p = 0.004) more likely if the blood transfusion lasted less than 30 minutes or more than 60 minutes, respectively, compared to 30 to 60 minutes. When compared to transfusion of up to two blood bags, transfusion of three to four blood bags and more than four blood bags increased the risk of transfusion adverse reaction by 1.67 times (p = 0.032) and 2.17 times (p = 0.049), respectively. Conclusion: Our research has revealed the prevalence and risk factors for transfusion adverses reactions. The introduction of prevention techniques would increase transfusion safety.

5612976 FIRST ADMINISTRATION OF HYPOXIC BLOOD IN A TRANSFUSION-DEPENDENT PATIENT

Background: Many patients with inherited and acquired anemias such as sickle cell disease, thalassemia and myelodysplastic syndromes (MDS) are transfusion-dependent, requiring regularly scheduled red blood cell (RBC) transfusions.1 Chronic transfusions are associated with a range of complications, such as transfusion-related adverse events (AEs) and iron overload.1 Frequent transfusions may also have a negative impact on patient quality of life (QoL)1 and access is often difficult. To reduce transfusion burden in dependent patients, Hemanext Inc. (Lexington, MA, United States) has developed a CE mark certified device to process and store red blood cells hypoxically - CPD/PAGGSM leukocytes-reduced (LR), O2/CO2 reduced.2 By reducing oxidative stress, hypoxic blood storage has been shown to improve the quality and function of RBCs,3 demonstrating that lower volumes of hypoxic RBCs are required to resuscitate from hemorrhagic shock and maintain hemodynamics than conventional RBCs in animal models.4 This may have several benefits in transfusion-dependent patients, including increasing the interval between transfusions and hence potential to reduce iron overload. Aims/Methods: A pilot clinical study in Norway is investigating the safety of a single administration of hypoxic RBCs in patients with hematologic malignancies and patients with burns. The primary outcome of the study is the occurrence of AEs at Day 7±1 post-transfusion. Secondary outcomes include assessment of AEs from enrollment to subsequent RBC transfusion (or Day 28) and the evolution of hemoglobin (Hb) levels pre- and post-transfusion. For the subset of patients with hematologic malignancies, the transfusion trigger is set to Hb <9.0 g/dL, and two units of hypoxic RBCs are administered. Results: In August 2022, following his informed consent, the first patient was transfused with hypoxic RBCs; this patient was also the first to receive hypoxic blood within Hemanext’s overall clinical program. The patient was an 80-year-old man who initially presented with anemia and diagnostic workup revealed bone marrow smear with morphological features of erythroid dysplasia with ring sideroblasts in 30% of cells and mutation in the SF3B1 gene. After initial response to treatment, he became transfusion-dependent, and has received 2 RBC units every 2 weeks for a year. The patient had a pre-transfusion Hb level of 8.1 g/dL and received 2 units of O+ hypoxic RBCs over 2 hours without any complications. No adverse events were recorded on Day 1 and the patient experienced no adverse events by Day 7. Further outcomes will be reported. Conclusion: Hypoxic RBCs processed with the CPD/PAGGSM LR, O2/CO2 reduced system were well tolerated in this patient; Hb level was within the target range at follow-up, supporting that hypoxically stored RBCs function appropriately. The study is ongoing and will continue to assess hypoxic RBCs in patients with hematologic malignancies and patients with burns. Enrolment within the wider clinical program – including studies investigating hypoxic RBC administration in patients with thalassemia in Italy and sickle cell disease in the US – is planned.

Investigation of Transfusion Adverse Events Patterns in Fayoum University Hospitals, Egypt: Hemovigilance Initiative

Background and Objective: Hemovigilance is an adverse reaction surveillance and monitoring system to improve the safety and quality of blood transfusion in terms of corrective and preventive action.  Identification of the adverse reactions and their risk factors will assist in taking appropriate steps to reduce their incidence and make blood transfusion safer. The aim of our study was to analyze the nature and incidence of transfusion related adverse events as a tool for implementation of hemovigilance system in Egypt.&#x0D; Study Design and Methods: Our study included all transfusion related adverse reactions from Fayoum University Hospital reported to the Blood Bank over a period of one year from August 2021 to July 2022.  All patients receiving transfusion and all blood donors according to The National Blood Transfusion Guidelines were included.  All reported reactions were analyzed, categorized and evaluated.&#x0D; Results: 28, 253 blood and blood components units were issued to 13, 544 patients. 273 (0.967%) transfusion related adverse reactions were reported to the blood bank. The most common reaction observed in recipients was allergic reaction 129 (47.25 %) followed by febrile non hemolytic transfusion reaction (FNHTR) 108 (39.56 %).&#x0D; Conclusion: Data related to transfusion related adverse reactions in developing countries are rare in literature. A strict quality assurance measures are required to build a hemovigilance system including, appropriate use of blood, maintain blood cold chain, monitoring, documenting and reporting transfusion reactions so that, the proper hemovigilance system can be attained.

Intermittent scavenging of storage lesion from stored red blood cells by electrospun nanofibrous sheets enhances their quality and shelf-life

Transfusion of healthy red blood cells (RBCs) is a lifesaving process. However, upon storing RBCs, a wide range of damage-associate molecular patterns (DAMPs), such as cell-free DNA, nucleosomes, free-hemoglobin, and poly-unsaturated-fatty-acids are generated. DAMPs can further damage RBCs; thus, the quality of stored RBCs declines during the storage and limits their shelf-life. Since these DAMPs consist of either positive or negative charged species, we developed taurine and acridine containing electrospun-nanofibrous-sheets (Tau-AcrNFS), featuring anionic, cationic charges and an DNA intercalating group on their surfaces. We show that Tau-AcrNFS are efficient in scavenging DAMPs from stored human and mice RBCs ex vivo. We find that intermittent scavenging of DAMPs by Tau-AcrNFS during the storage reduces the loss of RBC membrane integrity and reduces discocytes-to-spheroechinocytes transformation in stored-old-RBCs. We perform RBC-transfusion studies in mice to reveal that intermittent removal of DAMPs enhances the quality of stored-old-RBCs equivalent to freshly collected RBCs, and increases their shelf-life by ~22%. Such prophylactic technology may lead to the development of novel blood bags or medical device, and may therefore impact healthcare by reducing transfusion-related adverse effects.

A Prospective Randomized Study for Optimal Red Blood Cell Use Patients with Acute Myeloid Leukemia Receiving Dose Intensive Chemotherapy

Background: Although blood transfusion is fundamental throughout the course of hematologic malignancy, acute myeloid leukemia (AML) patients requiring intensive chemotherapy are left at the edges of patient blood management programs because current guidelines do not have established recommendations for a transfusion threshold in patients treated for hematological disorders nor for those with severe thrombocytopenia who are at risk of bleeding. Especially in the past 2 years, patient blood management programs gained more popularity with the spread of COVID-19. Due to blood inventory shortages, majority of the institutions lowered the hemoglobin (Hb) threshold to 7g/dL and this hit patients with hematologic malignancies especially hard. To close the gaps in inconsistencies of RBC transfusion care, we conducted a prospective trial focusing on newly diagnosed AML patients undergoing intensive chemotherapy. To the best of our knowledge, this is the first trial focusing on this unique subpopulation of patients. Also by doing so, we were able to shed some light on RBC transfusion optimization for patients with thrombocytopenia. Methods: This was a randomized trial of newly diagnosed AML diagnosed and treated between September 2018 and February 2022. Figure A outlines the study design. Patients were randomized into 4 groups using 2 by 2 factorial design, according to trigger (Hb 7 vs 8g/dL) and quantity (single-unit vs double-unit). In case patients became hemodynamically unstable due to major bleeding, severe infection, ischemic heart disease, stroke or any other compromising conditions, liberal RBC transfusion was allowed regardless of the grouping to ensure patients’ safety. Platelet transfusion was done liberally to maintain target platelet count between 10 - 20 x 109/L. Non-acute promyelocytic leukemia AML aged between 19 to 70 years old, undergoing cytarabine ± anthracycline chemotherapy were considered eligible for enrollment. The primary objective of the study was to compare the differences in the number of RBC units per case across the groups. The secondary outcomes included major bleeding and clinical relevant non-major bleeding (CRNM) according to ISTH, AML treatment outcomes according to International Working Group, platelet transfusion, RBC transfusion adherence rates (events of out of specification transfusion), transfusion related adverse events (AE), and infection complications Results: Initially 91 patients were randomized into 4 groups, but the protocol adherence rate was 90.1% (Figure B). As whole, patients received a median of 4 units of RBC (range 0-24) and AE rate associated with RBC transfusion was 16.9% (13/77). All 13 cases of AE were mild allergic and non-hemolytic reactions. There were no cases of fatal AEs such as anaphylaxis, acute hemolysis or transfusion-associated lung injury. Hemoglobin trigger did not affect the amount of RBC transfusion required during treatment. Patients receiving RBC transfusion at Hb < 7 g/dL used a median of 4 units of RBC (range 0-12), and those receiving transfusion at Hb < 8g/dL also used a median of 4 units of RBC (range 0-24) (P=0.305). The AE rates associated with RBC transfusion were similar between the 2 groups (P=0.286). As for platelet transfusion, there were no differences regards to transfusion frequency (P=0.256) or amount (P=0.258) between the 2 groups. Quantity of RBC per transfusion did not affect the total amount of RBC transfusion required during treatment. Patients receiving 2 units of RBC per transfusion used similar amount of RBC as patients receiving 1 unit of RBC per transfusion. There were no differences in platelet transfusion frequency (P=0.256) or amount (P=0.258) between the 2 groups. Overall, treatment outcomes did not differ across the 4 groups. There were 3 cases of major bleeding: 2 cases of gastrointestinal bleeding and 1 case of muscle hematoma. There was 1 case of CRNM: the patient had grade 1 epistaxis that did not require intervention. There were 4 deaths during the follow-up: 2 due to uncontrolled AML and 2 due to infection. Conclusion: This study establishes feasibility for restrictive RBC transfusion in AML patients undergoing chemotherapy. For stable patients without significant medical history, RBC transfusion can be safely initiated when Hb < 7g/dL and 1 unit is adequate. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Replicated Adsorption Technique used to Resolve ALX148 Interference in the Immunohematology Reference Laboratory

Abstract Introduction/Objective Increased expression of CD47 by cancer cells inhibits macrophages' phagocytic activity through CD47-SIRPα interactions, allowing evasion of the innate immune system. Several drugs on the market have been developed to target this interaction, including monoclonal therapeutics and fusion proteins. ALX148 is a genetically engineered SIRPα fusion protein with an inactivated Fc portion. CD47 is expressed highly on red blood cells (RBC), resulting in strong interference in pre-transfusion compatibility testing of patients receiving ALX148. Consequently, trial patients are at increased risk of transfusion-related adverse events or delay of needed transfusion. Few resolutions of ALX148 interference to assess underlying alloantibody development have been reported. One such examiniation demonstrated x6 linear papain-treated RBC adsorptions removed ALX148 interference. This study aimed to replicate these findings. Methods/Case Report Three patients receiving combination ALX148 (dose 6.57-20mg/mL) and Azacitidine therapy with broad-reactive RBC antibody reactivity were selected. High volume alloadsorptions (8:1 RBC:plasma) were performed with papain-treated rr (ccdee) RBCs. Adsorptions were incubated at 37C for 10 minutes. Polyethylene glycol (PEG) was utilized in test tube indirect antiglobulin testing (IAT). Results (if a Case Study enter NA) Initial reactivity strength was 3-4+ at PEG-IAT and saline-IAT with a three-cell screening RBC reagent. Alloadsorbed plasma was non-reactive at IAT with a three-cell screening RBC reagent enhanced by PEG. Drug interference was removed following three times high volume papain-treated alloadsorption. Conclusion Cancer immunotherapies have transformed the standard of care in oncology. Despite the evident clinical success, the medical laboratory has been challenged with adapting to cancer drug therapies capable of causing interference in routine laboratory testing. Clinical trials of ALX148 are associated with interference in pre-transfusion compatibility testing. The use of extended phenotype matching for RBC transfusion can be utilized but incurs additional time and resources. These results suggest high volume linear papain RBC alloadsorptions may be incorporated into antibody resolution for patients receiving ALX148.

Haematological patients' perception of home transfusions: Effect of the COVID-19 pandemic.

The COVID-19 pandemic has led to a growing interest in hospital-at-home programmes, including home transfusion services. We studied whether the pandemic had influenced patients' perception of home transfusions. We conducted a survey among haematology patients who receive transfusions in the hospital day care facility. Patients were asked about the burden of day care transfusions and whether they would prefer receiving home transfusions. The survey was conducted during the COVID-19 pandemic, and the results were compared with a survey performed before the pandemic (baseline). Sixty patients were included in the COVID-19 cohort and 31 patients in the baseline cohort. There was a non-significant decrease in the proportion of patients willing to receive home transfusions during the pandemic compared with baseline (35% vs. 47%, respectively, p=0.28). More patients in the COVID-19 cohort were afraid to receive home transfusions (60% compared with 48% at baseline, p=0.29), and fewer patients believed that hospital transfusion impaired their quality of life (19% compared with 36% at baseline, p=0.09). These unexpected results may be partly attributed to the shorter time needed to arrive at the hospital during the pandemic and a greater fear of having transfusion-related adverse effects at home. Our results show that the pandemic did not increase the willingness of patients to receive home transfusions, with a non-significant drift towards refusal of home transfusions. Patients' opinions should be taken into consideration when planning for future home transfusion services, by creating a comprehensive approach to patients' needs.

Adverse events of red blood cell transfusions in patients with sickle cell disease

Blood transfusion is a common medical intervention for patients with sickle cell disease (SCD) and disease related complications. While patients with SCD are at risk for all transfusion related adverse events defined by the National Healthcare Safety Network (NHSN) Biovigilance Component Hemovigilance Module Surveillance Protocol, they are uniquely susceptible to certain adverse events. This review discusses risk factors, mitigation strategies, and management recommendations for alloimmunization, hemolytic transfusion reactions, hyperviscosity and transfusion-associated iron overload in the context of SCD.

Detection of allergic transfusion-related adverse events from electronic medical records.

Transfusion-related adverse events can be unrecognized and unreported. As part of the US Food and Drug Administration's Center for Biologics Evaluation and Research Biologics Effectiveness and Safety initiative, we explored whether machine learning methods, such as natural language processing (NLP), can identify and report transfusion allergic reactions (ARs) from electronic health records (EHRs). In a 4-year period, all 146 reported transfusion ARs were pulled from a database of 86,764 transfusions in an academic health system, along with a random sample of 605 transfusions without reported ARs. Structured and unstructured EHR data were retrieved, including demographics, new symptoms, medications, and lab results. In unstructured data, evidence from clinicians' notes, test results, and prescriptions fields identified transfusion ARs, which were used to extract NLP features. Clinician reviews of selected validation cases assessed and confirmed model performance. Clinician reviews of selected validation cases yielded a sensitivity of 67.9% and a specificity of 97.5% at a threshold of 0.9, with a positive predictive value (PPV) of 84%, estimated to 4.5% when extrapolated to match transfusion AR incidence in the full transfusion dataset. A higher threshold achieved sensitivity of 43% with specificity/PPV of 100% in our validation set. Essential features predicting ARs were recognized transfusion reactions, administration of antihistamines or glucocorticoids, and skin symptoms (e.g., hives and itching). Removal of NLP features decreased model performance. NLP algorithms can identify transfusion reactions from the EHR with a reasonable level of precision for subsequent clinician review and confirmation.

Noninfectious Complications of Blood Transfusion in the South of Kerman Province: A 4-Year Retrospective Study

Background: Although today, transfusion therapy has turned from a hazardous condition to a relatively safe method with the improvement of technology, the highest risk for the patient is a complication of blood transfusions. This study aimed to evaluate the prevalence and pattern of transfusion-related adverse events. Materials and Methods: This study is a retrospective review which examined data of all those who received blood transfusions at Kashani and Imam Khomeini hospitals of the south of Kerman province from 2014 to 2018 years. Results: Of the total 16081 blood transfusions, 148 (0.92%) cases of blood complications were observed. Most cases occurred in males aged 31-40 and over 50 years, O blood group, injection packed red blood cell (PRBC) product, and within 20-60 minutes. Most of the transfusion-related complications were related to the surgery ward and in patients without underlying disease, and most complications included fever and chills. Conclusion: The results of our study showed that the highest transfusion-related complications were fever and chills. Therefore, fever and chills in the early hours of transfusion should be considered as the most common transfusion-related complications.

Lowering platelet count threshold to 10,000/µL for peripherally inserted central catheter placement safely conserves blood products.

Despite the low risk of peripherally inserted central catheter (PICC) insertion-related bleeding, the practice of administering prophylactic platelets varies greatly. Limiting unnecessary blood product transfusions reduces transfusion-related adverse events, financial cost, and delays in care. We assessed the impact of lowering prophylactic platelet administration threshold on blood product utilization patterns and bleeding events. This quasi-experimental study was conducted in an urban academic tertiary medical center. The study population included patients with platelet counts ≥ 10,000/µL and < 50,000/µL undergoing PICC placement in 2018 and 2019 when the minimum platelet thresholds were 50,000/µL and 10,000/µL, respectively. The primary outcome was blood product utilization and the secondary outcome was PICC insertion-related bleeding complications. Thirty-five patients using the 10,000/µL (10K) platelet threshold and 46 patients using the 50,000/µL (50K) platelet threshold were enrolled. The 50K group received more platelets before PICC insertion (0.870 ± 0.885 and 0.143 ± 0.430 pools of platelets-per-person, p < 0.001). No patients experienced clinically significant bleeding. Immediately following PICC insertion, minor bleeding occurred in five patients (two [4.3%] and three [8.6%] in the 50K and 10K groups, respectively). Bleeding rates between the two cohorts did not differ (p = 0.647). Lowering the minimum platelet threshold from 50,000/µL to 10,000/µL resulted in less prophylactic platelet and total blood product administration with no appreciable difference in PICC insertion-related bleeding.

Initial experiences of prehospital blood product transfusions between 2016 and 2020 in Päijät-Häme hospital district, Finland

BackgroundTreating hemorrhaging patients with prehospital blood product transfusions (PHBT) narrows transfusion delays and potentially benefits the patient. We describe our initial experiences of PHBT in a ground-based emergency medical service (EMS), where the transfusion protocol covers both traumatic and nontraumatic hemorrhaging patients.MethodsA descriptive retrospective analysis was performed on the records of all the patients receiving red blood cells, freeze-dried plasma, or both during prehospital care from September 2016 to December 2020. The delays of PHBT and the effects on patients’ vital signs were analyzed and reported as the median and interquartile range (IQR) and analyzed using a Wilcoxon Signed rank test.Results65 patients received prehospital blood product transfusions (PHBT), 29 (45%) were non-traumatic, and 36 (55%) traumatic. The main two reasons for PHBT were blunt trauma (n = 30, 46%) and gastrointestinal hemorrhage (n = 20, 31%). The median time from the emergency call to the start of PHBT was 54 min (IQR 38), and the transfusion began on a median of 61 min (IQR 42) before arrival at the hospital. The median systolic blood pressure improved from a median 76.5 mmHg (IQR 36.5) before transfusion to a median of 116.60 mmHg (IQR 26.5) (p < 0.001) on arrival to the hospital. No transfusion-related severe adverse events were noted.ConclusionsStarting PHBT in ground-based EMS is a feasible and viable option. The PHBT began significantly earlier than it would have started on arrival to the hospital, and it seems to be safe and improve patients’ physiology.Study approvalD/2603/07.01.04.05/2019.

Erythrocyte Storage Lesion Improvements Mediated by Naringin Screened from Vegetable/Fruit Juice Using Cell Extract and HPLC-MS.

In blood banking, storage at 4°C for weeks is known to cause damages to erythrocytes, called storage lesions that may later cause transfusion-related adverse events. In previous experiments, we found that vegetable/fruit juices can effectively reduce the storage lesion. Currently, we attempt to analyze the potential bioactive components and test whether the compounds can improve the storage lesions of erythrocytes. Equal portions in wet weight of 20 fresh vegetables and fruits were blended with phosphate buffered solution (PBS), and clear solutions were produced as additive to the packed erythrocytes from consented blood donors at 1 : 10 ratio (ml : gram). The blood samples were stored for 35 days at 4°C, and the supernatants were performed high liquid chromatography–mass spectrometry (HPLC-MS) analysis at 0 days, 14 days, and 35 days. The blood bags supplemented with identified bioactive components were stored in a refrigerator for 35 days, and the morphology, complete blood count (CBC), phosphatidylserine (PS) extroversion, hemolysis, and reactive oxygen species (ROS) levels were measured at the end of storage. Five potential bioactive components from vegetable/fruit juices contributed to the improvements of storage lesion. One of the compounds was unequivocally identified as naringin, and two were tentatively assigned as vitexin 6″-O-malonyl 2″-O-xyloside and luteolin 7-(6″-malonyl neohesperidoside). Naringin alleviated the storage lesion of red blood cells (RBCs) by reducing ROS levels and living cell extraction with HPLC-MS is a simple, reliable, and effective method for screening potential bioactive components.

Analyzing real world data of blood transfusion adverse events: Opportunities and challenges.

Blood transfusions are a vital component of modern healthcare, yet adverse reactions to blood product transfusions can cause morbidity, and rarely result in mortality. Therefore, accurate reporting of transfusion related adverse events (TRAEs) is paramount to improved transfusion practice. This study aims to investigate real-world data (RWD) on TRAEs by evaluating differences between ICD 9/10-based electronic health records (EHR) and blood bank-specific reporting. TRAE data were retrospectively collected from a blood bank-specific database between Jan 2015 and June 2019 as the reference data source and compared it to ICD 9/10 diagnostic codes corresponding to various TRAEs. Seven reactions that have corresponding ICD 9/10 diagnostic codes were evaluated: Transfusion related circulatory overload (TACO), transfusion related acute lung injury (TRALI), febrile non-hemolytic reaction (FNHTR), transfusion-related anaphylactic reaction (TRA), acute hemolytic transfusion reaction (AHTR), delayed hemolytic transfusion reaction (DHTR), and delayed serologic reaction (DSTR). These accounted for 33% of the TRAEs at an academic institution during the study period. Among 18637 adult blood transfusion recipients, there were 229 unique patients with 263 TRAE related ICD codes in the EHR, while there were 191 unique patients with 287 TRAEs identified in the blood bank database. None of the categories of reaction we investigated had perfect alignment between ICD 9/10 codes and blood bank specific diagnoses. Multiple systemic challenges were identified that hinder effective reporting of TRAEs. Identifying factors causing inconsistent reporting between blood banks and EHRs is paramount to developing effective workability between these electronic systems, as well as across clinical and laboratory teams.

Effectiveness of Enhanced Performance Feedback on Appropriate Use of Blood Transfusions

Auditing and feedback are frequently used to improve patient care. However, it remains unclear how to optimize feedback effectiveness for the appropriate use of treatments such as blood transfusion, a common but costly procedure that is more often overused than underused. To evaluate 2 theoretically informed feedback interventions to improve the appropriate use of blood transfusions. Two sequential, linked 2 × 2 cluster randomized trials were performed in hospitals in the UK participating in national audits of transfusion for perioperative anemia and management of hematological disorders. Data were collected for a surgical trial from October 1, 2014, to October 31, 2016, with follow-up completed on October 31, 2016. Data were collected for a hematological trial through follow-up from July 1, 2015, to June 30, 2017. Trial data were analyzed from November 1, 2016, to June 1, 2019. Hospitals were randomized to standard content or enhanced content to improve feedback clarity and usability and to standard support or enhanced support for staff to act on feedback. The primary end point was appropriateness of transfusions audited at 12 months. Secondary end points included volume of transfusions (aiming for reductions at patient and cluster levels) and transfusion-related adverse events and reactions. One hundred thirty-five of 152 eligible clusters participated in the surgical audit (2714 patients; mean [SD] age, 74.9 [14.0] years; 1809 women [66.7%]), and 134 of 141 participated in the hematological audit (4439 patients; median age, 72.0 [IQR, 64.0-80.0] years; 2641 men [59.5%]). Fifty-seven of 69 clusters (82.6%) in the surgical audit randomized to enhanced content downloaded reports compared with 52 of 66 clusters (78.8%) randomized to standard reports. Fifty-nine of 68 clusters (86.8%) randomized to enhanced support logged onto the toolkit. The proportion of patients with appropriate transfusions was 0.184 for standard content and 0.176 for enhanced content (adjusted odds ratio [OR], 0.91 [97.5% CI, 0.61-1.36]) and 0.181 for standard support and 0.180 for enhanced support (adjusted OR, 1.05 [97.5% CI, 0.68-1.61]). For the hematological audit, 53 of 66 clusters (80.3%) randomized to enhanced content downloaded the reports compared with 53 of 68 clusters (77.9%) randomized to standard content. Forty-nine of 67 clusters sites (73.1%) assigned to enhanced support logged into the toolkit at least once. The proportion of patients with appropriate transfusions was 0.744 for standard content and 0.714 for enhanced content (adjusted OR, 0.81 [97.5% CI, 0.56-1.12]), and 0.739 for standard support and 0.721 for enhanced support (adjusted OR, 0.96 [97.5% CI, 0.67-1.38]). This comparison of cluster randomized trials found that interventions to improve feedback usability and guide local action were no more effective than standard feedback in increasing the appropriate use of blood transfusions. Auditing and feedback delivered at scale is a complex and costly program; therefore, effective responses may depend on developing robust local quality improvement arrangements, which can be evaluated using rigorous experimental designs embedded within national programs. isrctn.org Identifier: ISRCTN15490813.

Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial)

There is a need for effective therapy for COVID-19 pneumonia. Convalescent plasma has antiviral activity and early observational studies suggested benefit in reducing COVID-19 severity. We investigated the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19 in a population with a high HIV prevalence and where few therapeutic options were available. We performed a double-blinded, multicenter, randomized controlled trial in one private and three public sector hospitals in South Africa. Adult participants with COVID-19 pneumonia requiring non-invasive oxygen were randomized 1:1 to receive a single transfusion of 200 mL of either convalescent plasma or 0.9% saline solution. The primary outcome measure was hospital discharge and/or improvement of ≥ 2 points on the World Health Organisation Blueprint Ordinal Scale for Clinical Improvement by day 28 of enrolment. The trial was stopped early for futility by the Data and Safety Monitoring Board. 103 participants, including 21 HIV positive individuals, were randomized at the time of premature trial termination: 52 in the convalescent plasma and 51 in the placebo group. The primary outcome occurred in 31 participants in the convalescent plasma group and and 32 participants in the placebo group (relative risk 1.03 (95% CI 0.77 to 1.38). Two grade 1 transfusion-related adverse events occurred. Participants who improved clinically received convalescent plasma with a higher median anti-SARS-CoV-2 neutralizing antibody titre compared with those who did not (298 versus 205 AU/mL). Our study contributes additional evidence for recommendations against the use of convalescent plasma for COVID-19 pneumonia. Safety and feasibility in this population supports future investigation for other indications.

Intraoperative Cell Salvage for Women at High Risk of Postpartum Hemorrhage During Cesarean Section: a Systematic Review and Meta-analysis.

Postpartum hemorrhage (PPH) can lead to substantial blood loss that compromises maternal hemodynamic stability and consequently cause severe maternal complications such as organ dysfunction or death. Intraoperative cell salvage (IOCS), an effective method of blood conservation used in other surgical specialties, can be an alternative intervention for managing PPH. Thus, our aim was to evaluate the efficacy and safety of IOCS for women at high risk of PPH undergoing cesarean sections. We conducted a systematic search of electronic databases from inception to February 25, 2021 for randomized controlled studies and observational studies published in English or Mandarin about IOCS use in cesarean sections. Primary outcomes of interest were changes in postoperative hematologic parameters and any adverse events reported among patients that had IOCS and controls that had an allogeneic blood transfusion. The certainty of the evidence of the outcomes was evaluated using the GRADE approach. A total of 24 studies with 5872 patients were included in the meta-analysis. Eleven randomized controlled trials (RCTs), and 13 observational studies were analyzed. Postoperative hemoglobin levels were higher among patients with IOCS SMD 0.39 (95% CI; 0.20, 0.60; P &lt; 0.001, high certainty). Allogeneic blood transfusion increased adverse events RR = 1.81(95% CI; 1.24, 2.62; P = 0.002, low certainty). IOCS shortened hospital stay SMD - 0.59 (95% CI: - 0.98, - 0.19; P = 0.004, low certainty) and shortened prothrombin time SMD - 0.67 (95% CI; - 1.31, - 0.04), P = 0.037, low certainty). The lower incidence of transfusion-related adverse events and shorter hospital stay among other findings demonstrate that IOCS use in obstetrics is an effective and safe alternative for the management of PPH; however, high-quality randomized control studies are required to confirm this evidence.