Using the French Hemovigilance Network database from 2007 to 2013, we provide information on demographics, incidence, and risk factors of reported transfusion-related acute lung injury (TRALI) and ...possible TRALI, analyze TRALI mitigation efforts for fresh frozen plasma and platelet concentrates, and consider the impact of platelet additive solutions on TRALI incidence. We applied the Toronto consensus conference definitions for TRALI and possible TRALI. Two TRALI subgroups were considered: “antibody positive” when a donor has human leukocyte antigen (class I or II) and/or human neutrophil antigen antibodies and the recipient has cognate antigen, and “antibody negative” when immunological investigation is negative or not done. The analysis targeted 378 cases, divided into antibody-positive TRALI (n=75), antibody-negative TRALI (n=100), and possible TRALI (n=203). TRALI patients were younger and received more blood components than the general population of transfused patients. Moreover, we identified the following clinical conditions where patients seemed to be at higher risk to develop TRALI: postpartum hemorrhage, acute myeloid leukemia, liver transplantation, allogeneic and autologous hematopoietic stem cells transplantation, polytrauma, and thrombotic microangiopathy. Policy measures intended to reduce antibody-positive TRALI were found effective for apheresis platelet concentrates and fresh frozen plasma but not for whole blood–derived platelet concentrates. The use of platelet additive solutions was associated with a significant reduction in the incidence of TRALI following transfusion of buffy coat–derived platelet concentrates but not following transfusion of apheresis platelets. Our data reinforce the concept that possible TRALI and TRALI, as defined in the Canadian consensus conference, share many characteristics. No specific policy measures are currently directed at mitigation of possible TRALI despite its impact on transfusion safety. Despite TRALI mitigation measures, the overall incidence of TRALI cases reported to the French Hemovigilance system was not significantly reduced. Therefore, additional research is needed to reduce, if not eradicate, all TRALI categories.
•The use of platelet additive solutions reduces TRALI incidence in case of platelet concentrates prepared from a pool of buffy coats, whereas no effect is observed with apheresis platelet concentrates.•0ne-third of TRALI and possible TRALI cases occur in the following populations: postpartum hemorrhage, polytrauma, liver transplant, acute myeloid leukemia, allogeneic and autologous hematopoietic stem cell transplant, and thrombotic microangiopathies.•Patients' clinical phenotypes of TRALI and possible TRALI are very similar, apart from the absence (TRALI) or presence (possible TRALI) of a risk factor of acute respiratory distress syndrome: with similar clinical feature and TRALI-related mortality, they share the same proportion of at-risk patients, the same mean number of blood component transfused, and the same proportion of the different blood component types transfused.•Although mitigation measures taken in France to prevent TRALI associated with donor human leukocyte antigen antibodies have been successful with apheresis platelet concentrates and fresh frozen plasma, the overall incidence of TRALI related with all blood components has not been significantly modified.
La anemia preoperatoria, la reintervención por sangrado y la necesidad de transfusión son problemas frecuentes en los pacientes tratados con una cirugía cardiaca mayor y se asocian a un aumento ...considerable de la morbimortalidad. El objetivo del presente trabajo es analizar nuestros resultados quirúrgicos tras la aplicación de un programa de patient blood management (PBM), poniendo el foco en los parámetros hematológicos.
Entre marzo de 2021 y mayo de 2022 hemos intervenido consecutivamente a 104 pacientes de cirugía cardiaca mayor con el programa PBM. La edad media fue de 65±11 años, el 66% fueron varones, el 21% tenían un EuroScore II>5, el 24% anemia preoperatoria y el 2,8% eran testigos de Jehová que rechazaban las transfusiones. El 19,2% de los procedimientos fueron coronarios sin circulación extracorpórea; el 8,7%, endocarditis; el 10,6%, reintervenciones; el 2,9%, síndromes aórticos agudos y el 34% fueron cirugías urgentes o emergentes.
La tasa de reoperación por sangrado fue del 1,9% y la de transfusión perioperatoria del 25%. El 87,5% de los pacientes operados de forma electiva y el 90,5% de los coronarios aislados no recibieron hemocomponentes. El número medio de concentrados de hematíes (índice de transfusión total), unidades de plasma fresco congelado y concentrados de plaquetas transfundidos por paciente fue de 0,47; 0,16 y 0,07, respectivamente.
El PBM nos ha permitido alcanzar nuestros objetivos de calidad en cuanto a reintervención por sangrado y tasa de transfusión perioperatoria.
Preoperative anemia, reexploration for bleeding and need for transfusion are common problems in patients undergoing mayor cardiac surgery and are associated with an increase morbidity and mortality. The objective of the present report is to evaluate our surgical results focusing on hematological parameters after the implementation of a Patient Blood Management (PBM) program.
Between March 2021 and May 2022, we have consecutively operated on 104 mayor cardiac surgery patients with the PBM program. The mean patient age was 65±11 years, 66% of the patients were male, 21% had a EuroScore II>5, 24% had preoperative anemia, and 2,8% were Jehovah's Witnesses who refused transfusions. The 19,2% of the procedures were off-pump coronary artery bypass grafting, 8,7% endocarditis, 10,6% redo operations, 2,9% acute aortic syndromes, and 34% urgent or emergent cases.
The incidence of reexploration for bleeding was 1,9% and the perioperative transfusion rate was 25%; 87,5% of the patients operated on electively and 90,5% of the isolated coronary patients did not receive blood components. The mean number of red blood cell concentrates (total transfusion index), fresh frozen plasma, and pooled platelets transfused per patient was 0.47, 0.16, and 0.07, respectively.
The PBM has allowed us to achieve our quality objectives in terms of reintervention for bleeding and perioperative transfusion rate.
Objectives.To determine physicians' preferred content and format for the Guidelines for Red Blood Cell and Plasma Transfusion for Adults and Children before development in order to guide the ...development process. To obtain physicians' recommendations about the Guidelines' content, format, dissemination and future directions after development to guide future work on the Guidelines. Design.Pre-post Guidelines qualitative design using 20 focus group (nine pre and 11 post). Study participants.One-hundred and seven physicians (5-11 per group) who used at least 1 unit of blood over the past 6 months; with a minimum of 1 year in practice and not retired. A total of 24 physicians attended both pre and post focus groups. In general, specialities of participants included: general practice, surgery, pediatrics, obstetrics/gynecology and hematology/oncology. Years of practice ranged from 1 to 35 years (mean=7 years). Main outcome measures.Pre Guidelines focus groups made recommendations on the content and format of the Guidelines, post Guidelines focus groups made recommendations on the same areas along with dissemination and future directions. Results.Three main components of the Guidelines were evaluated: content, format and dissemination. The content, which followed as much as possible that recommended by pre Guidelines focus groups, was deemed appropriate by post Guidelines focus groups, with minor gaps noted (e.g. information on alternatives to blood products). The format addressed many of the concerns raised by pre Guidelines focus groups; however, the post Guidelines focus groups were concerned about the lack of visual aids and categorization of information. The dissemination strategy was successful at diffusing the Guidelines, with some concerns expressed about reaching specific physician target groups. Conclusion.The pre-post focus group method was useful in conducting an evaluation of the Guidelines and this method which examined content, format and dissemination could contribute to evaluations of other guidelines.
The large-scale utilization of allogenic blood transfusion and its associated outcomes have been described in critically ill patients and those undergoing high-risk cardiac surgery but not in ...patients undergoing elective total hip arthroplasty. The objective of this study was to determine the trends in utilization and outcomes of allogenic blood transfusion in patients undergoing primary total hip arthroplasty in the United States from 2000 to 2009.
An observational cohort of 2,087,423 patients who underwent primary total hip arthroplasty from 2000 to 2009 was identified in the Nationwide Inpatient Sample. International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes 99.03 and 99.04 were used to identify patients who received allogenic blood products during their hospital stay. Risk factors for allogenic transfusions were identified with use of multivariable logistic regression models. We used propensity score matching to estimate the adjusted association between transfusion and surgical outcomes.
The rate of allogenic blood transfusion increased from 11.8% in 2000 to 19.0% in 2009. Patient-related risk factors for receiving an allogenic blood transfusion include an older age, female sex, black race, and Medicaid insurance. Hospital-related risk factors include rural location, smaller size, and non-academic status. After adjusting for confounders, allogenic blood transfusion was associated with a longer hospital stay (0.58 ± 0.02 day; p < 0.001), increased costs ($1731 ± $49 in 2009 U.S. dollars; p < 0.001), increased rate of discharge to an inpatient facility (odds ratio, 1.28; 95% confidence interval, 1.26 to 1.31), and worse surgical and medical outcomes. In-hospital mortality was not affected by allogenic blood transfusion (odds ratio, 0.97; 95% confidence interval, 0.77 to 1.21).
The increase in allogenic blood transfusion among total hip arthroplasty patients is concerning considering the associated increase in surgical complications and adverse events. The risk factors for transfusion and its impact on costs and inpatient outcomes can potentially be used to enhance patient care through optimizing preoperative discussions and effective utilization of blood-conservation methods.
Background
In 2010, health care facilities in the United States began voluntary enrollment in the National Healthcare Safety Network (NHSN) Hemovigilance Module. Participants report transfusion ...practices; red blood cell, platelet (PLT), plasma, and cryoprecipitate units transfused; and transfusion‐related adverse reactions and process errors to the Centers for Disease Control and Prevention through a secure, Internet‐accessible surveillance application available to transfusing facilities.
Study Design and Methods
Facilities submitting at least 1 month of transfused components data and adverse reactions from January 1, 2010, to December 31, 2012, were included in this analysis. Adverse reaction rates for transfused components, stratified by component type and collection and modification methods, were calculated.
Results
In 2010 to 2012, a total of 77 facilities reported 5136 adverse reactions among 2,144,723 components transfused (239.5/100,000). Allergic (46.8%) and febrile nonhemolytic (36.1%) reactions were most frequent; 7.2% of all reactions were severe or life‐threatening and 0.1% were fatal. PLT transfusions (421.7/100,000) had the highest adverse reaction rate.
Conclusion
Adverse transfusion reaction rates from the NHSN Hemovigilance Module in the United States are comparable to early hemovigilance reporting from other countries. Although severe reactions are infrequent, the numbers of transfusion reactions in US hospitals suggest that interventions to prevent these reactions are important for patient safety. Further investigation is needed to understand the apparent increased risk of reactions from apheresis‐derived blood components. Comprehensive evaluation, including data validation, is important to continued refinement of the module.
Summary Background Haematoma expansion is a major cause of mortality in intracranial haemorrhage related to vitamin K antagonists (VKA-ICH). Normalisation of the international normalised ratio (INR) ...is recommended, but optimum haemostatic management is controversial. We assessed the safety and efficacy of fresh frozen plasma (FFP) versus prothrombin complex concentrate (PCC) in patients with VKA-ICH. Methods We did an investigator-initiated, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Patients aged at least 18 years with VKA-ICH who presented within 12 h after symptom onset with an INR of at least 2·0 were randomly assigned (1:1) by numbered sealed envelopes to 20 mL/kg of intravenous FFP or 30 IU/kg of intravenous four-factor PCC within 1 h after initial cerebral CT scan. The primary endpoint was the proportion of patients with INR 1·2 or lower within 3 h of treatment initiation. Masking of treatment was not possible, but the primary analysis was observer masked. Analyses were done using a treated-as-randomised approach. This trial is registered with EudraCT, number 2008-005653-37, and ClinicalTrials.gov , number NCT00928915. Findings Between Aug 7, 2009, and Jan 9, 2015, 54 patients were randomly assigned (26 to FFP and 28 to PCC) and 50 received study drug (23 FFP and 27 PCC). The trial was terminated on Feb 6, 2015, after inclusion of 50 patients after a safety analysis because of safety concerns. Two (9%) of 23 patients in the FFP group versus 18 (67%) of 27 in the PCC group reached the primary endpoint (adjusted odds ratio 30·6, 95% CI 4·7–197·9; p=0·0003). 13 patients died: eight (35%) of 23 in the FFP group (five from haematoma expansion, all occurring within 48 h after symptom onset) and five (19%) of 27 in the PCC group (none from haematoma expansion), the first of which occurred on day 5 after start of treatment. Three thromboembolic events occurred within 3 days (one in the FFP group and two in the PCC group), and six after day 12 (one and five). 43 serious adverse events (20 in the FFP group and 23 in the PCC group) occurred in 26 patients. Six serious adverse events were judged to be FFP related (four cases of haematoma expansion, one anaphylactic reaction, and one ischaemic stroke) and two PCC related (ischaemic stroke and pulmonary embolism). Interpretation In patients with VKA-related intracranial hemorrhage, four-factor PCC might be superior to FFP with respect to normalising the INR, and faster INR normalisation seemed to be associated with smaller haematoma expansion. Although an effect of PCC on clinical outcomes remains to be shown, our data favour the use of PCC over FFP in intracranial haemorrhage related to VKA. Funding Octapharma.
Background
Allogeneic blood products transfusion during liver transplantation (LT) can be associated with increased morbidity and mortality. Data on thromboelastometry (ROTEM)‐guided coagulation ...management with coagulation factor concentrates (CFCs)—fibrinogen concentrate and/or prothrombin complex concentrate (PCC)—are sparse. We aimed to retrospectively evaluate the safety events observed with this approach in our clinic.
Study Design and Methods
LT patients from January 2009 to December 2010 (n = 266) were identified by chart review. A ROTEM‐based algorithm with CFC guided the hemostatic therapy. Doppler ultrasound was used to evaluate thrombosis in the hepatic artery, portal vein, and hepatic veins. Stroke, myocardial ischemia, pulmonary embolism, and transfusion variables were recorded. Patients receiving CFC were included in the CFC group (n = 156); those not receiving CFC were included in the non‐CFC group (n = 110). Safety events were compared between these two groups.
Results
Allogeneic transfusion(s) in the 266 patients was low, with medians of 2 (interquartile range IQR, 0‐5), 0 (IQR 0‐0), and 0 (IQR 0‐1) units for red blood cells (RBCs), fresh‐frozen plasma (FFP), and platelets (PLTs), respectively. Ninety‐seven of 266 LTs (36.5%) were performed without RBCs transfusion, 227 (85.3%) without FFP, and 190 (71.4%) without PLTs. There were no significant differences in thrombotic, thromboembolic, and ischemic adverse events occurrence between the CFC group and the non‐CFC group (11/156 patients vs. 5/110; p = 0.31).
Conclusion
In LT, ROTEM‐guided treatment with fibrinogen concentrate and/or PCC did not appear to increase the occurrence of thrombosis and ischemic events compared to patients who did not receive these concentrates.
Traumatic hemorrhage is the leading cause of preventable death after trauma. Early transfusion of plasma and balanced transfusion have been shown to optimize survival, mitigate the acute coagulopathy ...of trauma, and restore the endothelial glycocalyx. There are a myriad of plasma formulations available worldwide, including fresh frozen plasma, thawed plasma, liquid plasma, plasma frozen within 24 h, and lyophilized plasma (LP). Significant equipoise exists in the literature regarding the optimal plasma formulation. LP is a freeze-dried formulation that was originally developed in the 1930s and used by the American and British military in World War II. It was subsequently discontinued due to risk of disease transmission from pooled donors. Recently, there has been a significant amount of research focusing on optimizing reconstitution of LP. Findings show that sterile water buffered with ascorbic acid results in decreased blood loss with suppression of systemic inflammation. We are now beginning to realize the creation of a plasma-derived formulation that rapidly produces the associated benefits without logistical or safety constraints. This review will highlight the history of plasma, detail the various types of plasma formulations currently available, their pathophysiological effects, impacts of storage on coagulation factors in vitro and in vivo, novel concepts, and future directions.
BACKGROUND: Fresh‐frozen plasma (FFP) is given to patients across a range of clinical settings, frequently in association with abnormalities of standard coagulation tests.
STUDY DESIGN AND METHODS: A ...UK‐wide study of FFP transfusion practice was undertaken to characterize the current patterns of administration and to evaluate the contribution of pretransfusion coagulation tests.
RESULTS: A total of 4969 FFP transfusions given to patients in 190 hospitals were analyzed, of which 93.3% were in adults and 6.7% in children or infants. FFP transfusions to adults were given most frequently in intensive‐treatment or high‐dependency units (32%), in operating rooms or recovery (23%), or on medical wards (22%). In adult patients 43% of all FFP transfusions were given in the absence of documented bleeding, as prophylaxis for abnormal coagulation tests or before procedures or surgery. There was wide variation in international normalized ratio (INR) or prothrombin times before FFP administration; in 30.9% of patients where the main reason for transfusion was prophylactic in the absence of bleeding the INR was 1.5 or less. Changes in standard coagulation results after FFP administration were generally very small for adults and children.
CONCLUSIONS: This study raises important questions about the clinical benefit of much of current FFP usage. It highlights the pressing need for better studies to inform and evaluate quantitative data for the effect of plasma on standard coagulation tests.
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