Transfusion-related Adverse Event Research Articles

Incorporating the concept of overtransfusion into hemovigilance monitoring: An expert-based definition and criteria from the International HIT-OVER Forum.

Liberal or overtransfusion (OT) may be regarded as "inappropriate," but it is not reported as a transfusion-related adverse event. A definition of OT is lacking. OT may include overdosing of components, giving the incorrect component, or unnecessary administration without evidence of need for transfusion. OT can be associated with hypercoagulability, thrombosis, alloimmunization, increased mortality, longer hospital stay, increased infection rates, and adverse cardiocirculatory events. In 2023, an expert panel formed a hemovigilance international taskforce embedded in the German Interdisciplinary Taskforce for Clinical Hemotherapy (IAKH). The group was charged with proposing simple criteria to be used by hemovigilance systems to document instances of OT. This international initiative combined a narrative review of the literature for the rate and outcomes of OT with transfusion error reports to propose a definition for OT, including a definition for transfusion-induced hypercoagulopathy (TIH), three new codes for OT/TIH and subcodes A to G, three severity categories (serious adverse event, adverse event, near miss), and four incident codes (definite, probable, possible, not determinable). These codes can be used by hemovigilance systems to appropriately document instances of OT. Global adoption of these codes within hemovigilance systems would assist with the recognition and reporting of instances of OT, promote effective policies for adequate clinical administration techniques, and support technical guidelines for avoidance of OT. Thereby, incorporation of OT into hemovigilance strategies could support adequate use of blood products, increase patient safety, and facilitate blood supply and availability.

Lowering Platelet Threshold to 20,000/μL for Fluoroscopy-Guided Lumbar Puncture Does Not Result in Observed Clinical Adverse Outcomes.

Fluoroscopic-guided lumbar puncture (FG-LP) is a common neuroradiologic procedure. Traditionally, a minimum platelet count (MPC) of 50,000/μL for this procedure has been required; however, we recently adopted a lower MPC threshold of 20,000/μL. The purpose of this study was to compare adverse events in patients undergoing FG-LP with MPCs above to those below the conventional 50,000/μL threshold. This was an institutional review board-approved, retrospective study on adult patients with hematologic malignancy undergoing FG-LP in the neuroradiology division between May 2021 and December 2022, after lowering the minimal required MPC to 20,000/μL. Recorded data included indication for FG-LP, preprocedure and postprocedure MPC, need for and number of platelet transfusions within 24 hours of FG-LP, presence of traumatic tap, FG-LP-related complications, and any platelet transfusion-related adverse event. Patients were classified into 2 groups based on MPC: (1) those above 50,000/μL and (2) those below 50,000/μL. Descriptive statistics were used comparing these 2 groups. One hundred twenty-eight patients underwent FG-LP, with 46 having an MPC between 20,000 and 50,000/μL and 82 having an MPC above 50,000/μL. No postprocedural complications were encountered in either group. Traumatic taps occurred in 10/46 (22%)​ with MPC below 50,000/μL versus 10/82 (12%)​ in those with MPC above 50,000/μL. Forty of 46 patients (87%) were transfused with platelets within 24 hours prior to FG-LP. One patient developed a transfusion-related reaction. Lowering the MPC threshold from 50,000/μL to 20,000/μL for FG-LP did not result in a higher incidence of spinal hematoma.

Post-Transfusion Takotsubo Cardiomyopathy

In three recent cases an initial transfusion-related adverse event (TRAE) occurred that had a significant respiratory component, and other features suggesting a severe allergic reaction. All were treated as such. Shortly after treatment the nature of the event changed to something resembling transfusion-associated circulatory overload (TACO).These cases suggest the possibility that a severe TRAE that is not TACO may precipitate TACO. In other words, some transfusions, sometimes, may deliver a ‘double whammy’. A possible mechanism might be through the development of Takotsubo, or stress, cardiomyopathy - a cause of acute, reversible, heart failure. Takotsubo cardiomyopathy typically presents with chest pain or shortness of breath. Ventricular wall dysfunction occurs, and characteristic echocardiographic abnormalities are seen. ECG and biochemical features suggest cardiac ischaemia. It is commoner in post-menopausal women. A range of ‘stressors’ - hypotension, asthma attacks, accidents, medical procedures, pain, bad news, etc. - may precipitate it. 1 Catecholamines such as adrenaline are believed to play a central role. They cause direct toxicity to the myocardium, and also coronary artery spasm, and increased cardiac workload. 2 One other such case is reported. There, a 48 years old post-menopausal woman developed acute reversible heart failure with the features of Takotsubo cardiomyopathy, following urticaria and pruritus, whilst having a platelet transfusion. No adrenaline was given, but the authors postulate that adrenergic and histaminergic elements may have combined to produce the effect on the heart. 3 Thus, in some patients the ‘perfect storm’ compounded of 1.borderline cardiac function,2.catecholamine release (secondary to the stress of the underlying disorder, the transfusion, and the TRAE),3.histamine release (in allergic TRAE),4.the treatment of the allergic reaction with adrenaline5.recent or ongoing volume overloadmay be sufficient to precipitate or exacerbate TACO. Careful consideration of cases with similar features is needed. Potential precipitating factors are modifiable or preventable.

The knowledge of transfusion and related practices among doctors at Universitas Academic Complex, Bloemfontein, South Africa

ObjectivesTo determine the knowledge of transfusion and related practices among doctors working at Universitas Academic Complex (UAC), Bloemfontein, South Africa. We aimed to describe training history, transfusion knowledge and reported haemovigilance reporting habits. MethodsA cross-sectional descriptive study was performed using an anonymous questionnaire distributed at departmental meetings. The study population included doctors working in adult disciplines that frequently transfuse blood from the UAC. Ethics approval was obtained from the University of the Free State, Health Sciences Research Ethics Committee. Permission to conduct the study was obtained from the Free State Department of Health. Results were summarised by frequencies and percentages. ResultsQuestionnaires of 152 respondents were analysed. Most of the respondents (31.5 %) were registrars and medical officers with less than 5 years’ experience, followed by specialists (19.9 %). Although prescribing habits varied, 43.3 % of respondents prescribe blood at least weekly. Almost a third (29.9 %) of respondents had never received any transfusion training. A haemoglobin-based transfusion trigger is used by 76.2 % of respondents. Almost 80 % of respondents reported using a single unit of blood followed by clinical reassessment before ordering a second unit. Cost of laboratory investigations and lack of human resources were the main reported obstacles to adequately investigating anaemia. Forty percent of respondents involved with the care of patients who suffered a transfusion related adverse event reported the event to the blood service. ConclusionAt the (UAC), where blood is frequently transfused, we note infrequent training, poor knowledge of some basic transfusion principles and poor haemovigilance reporting.

Resolution of the complexity of transfusion support by alloadsorption in a patient of thalassaemia intermedia with multiple alloantibodies

Thalassemia intermedia (TI) patients are generally more prone to alloimmunization against red blood cell antigen. Laboratory diagnosis of multiple alloantibodies faces challenges due to history of recent transfusion, lack of infrastructure, and skilled workforce. Alloadsorption is commonly used for a recently transfused patient suspected of having multiple alloantibodies. In this case, alloadsorption was performed with rr cells only to rule out the presence of allo-anti-E. Blood transfusion is the mainstay of treatment, and transfusion dependence is the primary measure for determining the severity. A 12-year-old young female patient, already diagnosed case of TI, presented with anemia, jaundice, and abdominal pain (on ultrasonography, hepatosplenomegaly and cholelithiasis) and planned for splenectomy with cholecystectomy. Cross-match was incompatible with the group-specific A-positive red cell unit in the antihuman globulin phase. Antibody screening and antibody identification (AI) revealed the possibility of anti-c and anti-E. Repeated alloadsorption with c+E-(rr) red cells, and further AI with remaining serum, confirmed the presence of both anti-c and anti-E. The patient was transfused with two units of c and E antigen-negative, A-positive compatible unit and operated without any transfusion-related adverse event. Here, we depicted the importance of alloadsorption as a tool to resolve multiple alloantibodies.

Initial Results of Empirical Cryoprecipitate Transfusion in the Treatment of Isolated Severe Traumatic Brain Injury: Use of In-house-produced Cryoprecipitate.

Acute coagulopathy is common after traumatic brain injury (TBI), particularly in severe cases of acute subdural hemorrhage (ASDH). Although acute coagulopathy is associated with poor outcomes, the optimal treatment strategy remains unknown. Here, we report the initial results of an empirical cryoprecipitate transfusion strategy that we developed as an early intervention for acute coagulopathy after TBI. We performed chart reviews of adult patients (aged ≥18 years) who received early cryoprecipitate transfusion after admission to our institution with a diagnosis of severe TBI (Glasgow Coma Scale ≤8) and ASDH from March 2013 to December 2016. We compared the outcomes of these patients with those who were treated before the implementation of the cryoprecipitate transfusion strategy (January 2011–February 2013). During the study period, 33 patients received early cryoprecipitate transfusion and no acute transfusion-related adverse event was reported. The rate of coagulopathy development within 24 h after admission was lower in these patients (23%) than in the controls (49%), but the difference was not significant (P = 0.062). The in-hospital mortality rate was 36% in patients receiving early cryoprecipitate transfusion and 52% in controls. After adjusting for confounding factors, the in-hospital mortality rate was significantly lower in the intervention period [adjusted odds ratio: 0.25, 95% confidence interval (CI): 0.08–0.78, P = 0.017]. In summary, we analyzed initial results of a cryoprecipitate transfusion strategy in patients with severe isolated TBI and ASDH. No acute transfusion-related adverse event was observed, and early transfusion of the in-house-produced cryoprecipitate may have reduced rates of coagulopathy development and in-hospital mortality.

Transfusion-related adverse reactions: From institutional hemovigilance effort to National Hemovigilance program.

Aims:In this study we have evaluated the various adverse reactions related to transfusion occurring in our institution as a pilot institutional effort toward a hemovigilance program. This study will also help in understanding the problems faced by blood banks/Transfusion Medicine departments in implementing an effective hemovigilance program.Materials and Methods:All the adverse reactions related to transfusion of whole blood and its components in various clinical specialties were studied for a period of 1 year. Any transfusion-related adverse event was worked up in accordance with guidelines laid down by the Directorate General of Health Services (DGHS) and departmental standard operating procedures.Results:During the study period from November 1, 2011 to October 31, 2012, 45812 components were issued [30939 WB/PRBC; 12704 fresh frozen plasma (FFP); 2169 platelets]. Risk estimation per 1000 units of red cells (WB/PRBC) transfused was estimated to be: 0.8 for febrile nonhemolytic transfusion reaction (FNHTR), 0.7 for allergic reaction, 0.19 for acute hemolytic transfusion reaction (AcHTR), 0.002 for anaphylactoid reactions, 0.1 for bacterial sepsis, and 0.06 for hypervolemia and hypocalcemia. 0.09 is the risk for delayed transfusion reaction and 0.03 is the risk for transfusion-related acute lung injury (TRALI). Risk estimate per 1,000 units of platelets transfused was estimated to be 1.38 for FNHTR, 1.18 for allergic reaction, and 1 in case of bacterial sepsis. Risk estimation per 1,000 units of FFP was estimated to be 0.15 for FNHTR and 0.2 for allergic reactions.Conclusions:Factors such as clerical checks at various levels, improvement in blood storage conditions outside blood banks, leukodepletion, better inventory management, careful donor screening, bedside monitoring of transfusion, and documentation of adverse events may decrease transfusion-related adverse events. Better coordination between transfusion specialists and various clinical specialties is the need of the hour and it will help in making the whole transfusion chain safe and effective. There is a need for a hemovigilance program at the national level so that true incidence and the spectrum of adverse events due to transfusion are known and policies formulated to minimize the risks associated with it.

Transfusion-related Acute Lung Injury in Obstetrics and Gynecology

ABSTRACT Transfusion-related acute lung injury (TRALI), a type of noncardiogenic pulmonary edema related to blood transfusion, is gaining prominence as a common adverse event related to blood transfusions in hospitals. It is typified by dyspnea, cough, hypoxemia and pulmonary edema within 6 hours of transfusion. Without any ‘gold standard’, the diagnosis of TRALI relies on a high index of suspicion and on excluding other types of transfusion reactions. As our understanding of TRALI deepens, risk reduction or prevention may become possible. The management of TRALI is early diagnosis and good supportive care with, occasionally ventilator support. With the increasing use of blood products in obstetrics and gynecology, awareness of this complication is desirable to prevent one of the commonest and most frequently under-recognized transfusion related adverse event of the present day. How to cite this article Kakade A, Kulkarni Y, Shukla H. Transfusion-related Acute Lung Injury in Obstetrics and Gynecology. J South Asian Feder Obst Gynae 2015;7(1)26-29.

Transfusion Of Very Low Birth Weight Neonates Using Allogeneic Cord Blood Derived RBC Units

Infants with very low birth weight (VLBW) frequently need transfusions of red blood cells (RBCs) during the first weeks of life. However, adult blood transfusions are acknowledged risk factors for several complications, including Retinopathy of Prematurity (ROP), cytomegalovirus infection and necrotizing enterocolitis. For ROP, for example, it is thought that adult hemoglobin (HbA), with lower affinity for oxygen than foetal HbF, may induce an oxidative damage (Romagnoli C. Early Hum Dev 2009; 85, 10 Suppl:S79-S82). Previous studies showed that autologous cord blood (CB) could serve as source of RBCs for transfuse neonates; nevertheless, his clinical use is still limited, expecially because of the small volumes achieved after processing of the UCB unit. In a previous study we demonstrated that CB derived buffy coat–depleted RBC units obtained through automated separation (Compomat G4®, Fresenius HemoCare, Germany) and stored in SAG-Mannitol solution represent a suitable product for homologous transfusion of neonates. Actually, CB RBC units show hemoglobin content and hematocrit (Htc) values similar to adult RBC units stored for comparable periods, whereas the lactate concentrations are lower and the pH values are higher (Bianchi et al. ASH Annual Meeting Abstracts 2012, 120:275). We are now assessing the feasibility of covering the transfusion needs of VLBW neonates using allogeneic CB packed RBC units collected at our Cord Blood Bank. This practice has never been used before and we show here for the first time our experience on allogeneic CB derived RBC transfusion. VLBW neonates admitted to the Neonatal Intensive Care Unit needing RBC transfusions in the first 28 days of life receive adult (A group) or CB (CB group) RBC units, on the basis of the availability of an AB0-Rh compatible CB RBC unit. The arm assignment drives the choice of the RBC products (adult versus CB) in case of subsequent transfusions. All patients receive a fixed dose of 20 ml/kg RBC. Htc values are acquired before and after transfusion (ΔHtc). CB RBC units are processed and stored as previously reported (Bianchi et al. ASH Annual Meeting Abstracts 2012, 120:275). After matching tests, CB and adult units are irradiated and filtered; the Purecell RN Neonatal filters (PALL Medical, UK) are used for CB units. So far, 9 patients entered the study. Five patients are in the A group and 4 in the CB group, with similar gestational age (mean 27 + 1 weeks in group A and 27 + 3 weeks in group CB, respectively), gender (male/female ratio 3/1 in A group and 4/1 in CB group, respectively) birth weight (mean weight 915 + 225 gr in A group and 918 + 389 gr in B group, respectively) and Htc values at birth (57.2 + 8.4% in A group and 55.5 + 5.2% in CB group, respectively). On the whole, 21 RBC units were transfused, 7 in the A group and 14 in the CB group. The mean storage time was 5 + 4 days for adult RBC units and 9 + 3 days for CB units. The Htc values of patients at the time of transfusion were similar in the two groups (32,2 + 4% in A group and 30.64 + 4% in CB group, respectively, p=0.287). The ΔHtc was similar in A and CB groups, with a mean increase of 15.1 + 5 % in A group and 13.3 + 5% in the CB group, respectively, p = 0,426). No transfusion related adverse event occurred in both arms. CB can be safely administrated to preterm infants: as compared to adult, cord blood is functionally more appropriate and is safer for infectious and immunological complications. Given the wide availability of discharged units at public cord blood banks, CB derived RBC transfusion can constitute a valid therapeutic option for VLBW neonates.The study was supported by a grant from Genitin (Associazione dei Genitori per la Terapia Intensiva Neonatale). Disclosures:No relevant conflicts of interest to declare.

Prévalence des anticorps antiplaquettes spécifiques chez les receveurs de concentrés plaquettaires avec effet indésirable transfusionnel

Purpose of the studyIn practice, platelet transfusions are frequently performed in patients with haematologic and/or oncologic diseases. Subsequent to these transfusions, platelet specific antibodies may develop and could induce adverse events, such as platelet transfusion refractoriness or post-transfusion purpura. In order to evaluate the prevalence of platelet specific antibodies in these recipients, adverse events with a request for platelet specific antibodies testing, were studied. Patients and methodsRecipients of platelet units with adverse event, excluding platelet transfusion refractoriness or post-transfusion purpura, were evaluated. ResultsFrom January 1st 2009 to October 31st 2011, 125 adverse events with platelet specific antibodies screening, corresponding to 116 recipients (64 females, 52 males) were included. The main aetiology of the adverse event was a febrile non-haemolytic transfusion reaction in 62 cases (49.6%) and allergy in 40 (32.0%). Most samples tested were post-transfusion solely (101 adverse events, 80.8%). Seven of these samples had free platelet specific antibodies, including four anti-HPA-5b, one anti-HPA-2a and two anti-GPIaIIa. In the cross-match test, platelet specific antibodies were found in two pre-transfusion samples (anti-GP IaIIa) and in five post-transfusion samples (anti-GPIaIIa, three cases; anti-GP IbIX, one case; anti-GP IIbIIIa and -GPIbIX, one case). ConclusionAccording to this study on platelet transfusion related adverse event, few platelet specific antibodies were detected on pre- and post-transfusion samples. The implementation of platelet specific antibodies testing before transfusion would give more accurate data and help prevent adverse events as typed platelets would be given when platelet specific antibodies were found.

Evaluation of the safety and feasibility of rapid rituximab infusion

To assess safety of rapid infusion by measuring infusion-related side effects and toxicities. Participants received the first rituximab infusion according to the manufacturers' recommendations. If well-tolerated, they then received the second and subsequent infusions at a rate of 20% of the dose over the first 30 min and the remaining 80% over the next hour. Premedication was administered for all the infusions. A total of 243 infusions in 65 consecutive participants were evaluated. Six experienced a grade 1 reaction and one a grade 3 transfusion-related adverse event. Three of these participants were withdrawn from the rapid infusion study. The other four participants (grade 1 only participants) were re-challenged. The same premedication was used as in the first rapid infusion. On experiencing a grade 1 reaction, promethazine 12.5 mg i.v. was administered and infusion recommenced at 50% of the previous rate upon the resolution of symptoms. Three patients developed a grade 1 adverse event and one patient experienced no adverse reaction. The three patients who did not tolerate the second rapid infusion were withdrawn from this study. A rituximab infusion over 90-min was safe and feasible for participants who seek treatment at ambulatory cancer centre. The new regimen has been adopted as a standard practice with better resource utilization.

Number Needed to Treat and Cost of Recombinant Human Erythropoietin to Avoid One Transfusion-Related Adverse Event in Critically Ill Patients

Number Needed to Treat and Cost of Recombinant Human Erythropoietin to Avoid One Transfusion-Related Adverse Event in Critically Ill Patients

Number Needed to Treat and Cost of Recombinant Human Erythropoietin to Avoid One Transfusion-Related Adverse Event in Critically III Patients

Number Needed to Treat and Cost of Recombinant Human Erythropoietin to Avoid One Transfusion-Related Adverse Event in Critically III Patients

Number needed to treat and cost of recombinant human erythropoietin to avoid one transfusion-related adverse event in critically ill patients*

To calculate the absolute risk reduction of transfusion-related adverse events, the number of patients needed to treat, and cost to avoid one transfusion-related adverse event by using erythropoietin in critically ill patients Number needed to treat with sensitivity analysis. Teaching hospital. Hypothetical cohort of critically ill patients who were candidates to receive erythropoietin. Using vs. not using erythropoietin to reduce the need for packed red blood cell transfusions. We used published estimates of known transfusion risks: transfusion-related acute lung injury, transfusion-related errors, hepatitis B and C, human immunodeficiency virus, human T-cell lymphotropic virus, and bacterial contamination, stratified by severity. Based on the estimated risk and frequency of transfusions with and without erythropoietin, we calculated the absolute risk reduction of transfusion-related adverse events, the number needed to treat, and cost to avoid one transfusion-related adverse event by using erythropoietin. The estimated incidence of transfusion-related adverse event was 318 permillion units transfused for all transfusion-related adverse events, 58 per million for serious transfusion-related adverse events, and 21 per million for likely fatal transfusion-related adverse events. The routine use of erythropoietin resulted in an absolute risk reduction of 191 per million for all transfusion-related adverse events, 35 per million for serious transfusion-related adverse events, and 12 per million for likely fatal transfusion-related adverse events. The number needed to treat was 5,246 to avoid one transfusion-related adverse event, 28,785 to avoid a serious transfusion-related adverse event, and 81,000 for a likely fatal transfusion-related adverse event. The total cost was $4,700,000 to avoid one transfusion-related adverse event, $25,600,000 to avoid one serious transfusion-related adverse event, and $71,800,000 to avoid a likely fatal transfusion-related adverse event. The magnitude of these results withstood extensive sensitivity analysis. From the perspective of avoidance of adverse events, erythropoietin does not appear to be an efficient use of limited resources for routine use in critically ill patients.