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1.
BMJ Open ; 14(6): e084847, 2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38830735

RESUMO

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.


Assuntos
Antifibrinolíticos , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/uso terapêutico , Ácido Tranexâmico/administração & dosagem , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/administração & dosagem , Canadá , Perda Sanguínea Cirúrgica/prevenção & controle , Estudos Cross-Over , Transfusão de Eritrócitos , Política Organizacional
2.
BMJ Open ; 14(5): e078853, 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38719323

RESUMO

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.


Assuntos
Antifibrinolíticos , Derivação Gástrica , Obesidade Mórbida , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/uso terapêutico , Derivação Gástrica/efeitos adversos , Derivação Gástrica/métodos , Obesidade Mórbida/cirurgia , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Método Duplo-Cego , Hemorragia Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Feminino , Estudos Multicêntricos como Assunto , Adulto , Países Baixos , Ensaios Clínicos Fase III como Assunto , Masculino
3.
Lab Med ; 55(4): 517-519, 2024 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-38346103

RESUMO

RhD alloimmunization from platelet transfusions have been documented in the literature. However, non-RhD platelet alloimmunization is much less frequent and the risk for non-RhD alloimmunization from platelets is thought to be extremely low and most associated with buffy coat pooled platelets. A 22-month-old male with acute myeloid leukemia received 99 mL apheresis platelets for thrombocytopenia. Three months later, an antibody screen, the direct antiglobulin test (DAT), and red blood cell (RBC) genotype were sent for laboratory evaluation. The antibody screen was positive, with anti-E identified. The DAT was negative and the RBC genotype of the patient was predicted to be negative for the E antigen whereas the platelet donor was predicted to be positive for E antigen. There is a risk of alloimmunization of non-RhD antigen from platelet pheresis transfusion even in a patient less than 2 years old.


Assuntos
Leucemia Mieloide Aguda , Transfusão de Plaquetas , Humanos , Masculino , Leucemia Mieloide Aguda/terapia , Lactente , Transfusão de Plaquetas/efeitos adversos , Plaquetoferese , Isoanticorpos/imunologia , Isoanticorpos/sangue , Trombocitopenia/terapia , Trombocitopenia/etiologia , Trombocitopenia/imunologia
4.
BMJ Open ; 14(1): e080952, 2024 01 24.
Artigo em Inglês | MEDLINE | ID: mdl-38267243

RESUMO

INTRODUCTION: Postoperative anaemia is prevalent in adult spinal deformity (ASD) surgery in association with unfavourable outcomes. Ferric derisomaltose, a novel iron supplement, offers a promising solution in rapidly treating postoperative anaemia. However, the clinical evidence of its effect on patients receiving spinal surgery remains inadequate. This randomised controlled trial aims to evaluate the safety and efficacy of ferric derisomaltose on postoperative anaemia in ASD patients. METHODS AND ANALYSIS: This single-centre, phase 4, randomised controlled trial will be conducted at Department of Orthopaedics at Peking Union Medical College Hospital and aims to recruit adult patients who received ASD surgery with postoperative anaemia. Eligible participants will be randomly assigned to receive ferric derisomaltose infusion or oral ferrous succinate. The primary outcome is the change in haemoglobin concentrations from postoperative days 1-14. Secondary outcomes include changes in iron parameters, reticulocyte parameters, postoperative complications, allogeneic red blood cell infusion rates, length of hospital stay, functional assessment and quality-of-life evaluation. ETHICS AND DISSEMINATION: This study has been approved by the Research Ethics Committee of Peking Union Medical College Hospital and registered at ClinicalTrials.gov. Informed consent will be obtained from all participants prior to enrolment and the study will be conducted in accordance with the principles of the Declaration of Helsinki. The results of this study are expected to be disseminated through peer-reviewed journals and academic conferences. TRIAL REGISTRATION NUMBER: NCT05714007.


Assuntos
Anemia , Adulto , Humanos , Anemia/tratamento farmacológico , Anemia/etiologia , Ferro , Dissacarídeos , Eritrócitos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ensaios Clínicos Fase IV como Assunto , Compostos Férricos
5.
Rev. Assoc. Med. Bras. (1992, Impr.) ; 70(2): e20230816, 2024. tab
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1535090

RESUMO

SUMMARY OBJECTIVE: The aim of this study was to analyze the prescription of packed red blood cells performed by emergency physicians for adults with sickle cell anemia. METHODS: Transfusions performed in adults with sickle cell anemia treated at an emergency service in São Bernardo do Campo, São Paulo Brazil, between January 2018 and January 2022 were evaluated. For data comparison, the chi-square2 test was used. The significance level adopted was 5%. RESULTS: A total of 114 transfusions were performed. The mean age was 41.8±16.4 years, and pretransfusion hemoglobin was 6.1±1.23 g/dL. Regarding the indication, the adequacy of transfusions performed in symptomatic individuals was significantly higher compared to asymptomatic individuals (100% vs. 3.9%, p<0.001). Symptomatic individuals received excessive volumes of packed red blood cells less frequently than asymptomatic individuals (17.5% vs. 56.9%, p<0.001). The filtered subtype, indicated for sickle cell anemia, was prescribed in only a quarter of the patients. However, non-indicated subtypes were frequently prescribed. CONCLUSION: This study found low adequacy in the indication and calculation of the transfusion volume of packed red blood cells in asymptomatic individuals. Few patients received filtered red blood cells, resulting in increased risks of transfusion reactions. On the contrary, non-indicated subtypes were prescribed in a quarter of transfusions, which resulted in higher costs and delay in receiving packed red blood cells.

6.
Transfus Apher Sci ; 63(1): 103862, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38135545

RESUMO

BACKGROUND AND OBJECTIVES: ABO-incompatible transplantations allow patients to receive timely transplants. Isoagglutinin titration to ascertain levels of incompatible antibodies in the recipient is important in determining patient selection and transplant survivability. To find out the prevalent trends in India, the largest, first of its kind survey was carried out among the transplant centers regarding their practices in isoagglutinin titration. METHODS: The survey was drafted by a working group of Transfusion and Transplant Immunology specialists from six different centers. Data was obtained via the use of an online questionnaire. RESULTS: Results were categorized into four categories, Hospital information, Titration methodology, Role of transfusion specialists and cut-off titers. Most centers had a well-established solid-organ transplant program with considerable number of ABO-incompatible transplantations. Most centers performed isoagglutinin titration in Transfusion Medicine department. Column Agglutination Technique (CAT) was the most common method, using EDTA blood samples and freshly-prepared in-house pooled cells. Most centers had a turn-around time of less than 12 h. While the policy for ascertaining baseline and threshold titers is well-defined in ABO-incompatible renal transplants, variations from center to center still exist for ABO-incompatible liver transplants. Most centers required a Transfusion Medicine consultation for the patients before such transplants. CONCLUSION: With increasing ABO-incompatible kidney and liver transplants across the country, the role of Transfusion medicine specialists has become vital in pre-conditioning regimes enabling the viability and success of such transplants. This was a unique survey that provided a snapshot of current trends and practices of isoagglutinin titration for ABO-incompatible transplants in India.


Assuntos
Transplante de Rim , Transplante de Fígado , Transplante de Órgãos , Humanos , Incompatibilidade de Grupos Sanguíneos , Transplante de Rim/métodos , Rim , Sistema ABO de Grupos Sanguíneos
7.
Rev. cuba. med. mil ; 52(4)dic. 2023.
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1559860

RESUMO

Introducción: Las características de los donantes de sangre pueden variar entre centros de hemoterapia y pueden relacionarse con la seropositividad de marcadores infecciosos. Objetivo: Relacionar la seropositividad de marcadores infecciosos con los factores demográficos de los donantes de sangre peruanos. Métodos: Estudio observacional en los bancos de sangre del hospital nacional Cayetano Heredia y el Instituto Nacional Materno Perinatal durante el año 2019. La población la conformaron los 11 936 donantes que fueron tamizados para 7 agentes infecciosos según el Programa Nacional de Hemoterapia y Banco de Sangre. Se usó la prueba de correlación de Pearson para determinar la asociación entre las variables demográficas con los marcadores infecciosos. Resultados: Del total 8449 (70,8 %) fueron varones y el grupo etario de 35 a 55 años fue el más frecuente en ambos hospitales (~ 44,5 %). La mayoría de donantes procedían de la costa (4944; 41,4 %), aunque en el Hospital Nacional Cayetano Heredia hubo 734 (8,9 %) de la selva. La seropositividad fue de 507 (4,25 %) donaciones; los más frecuentes fueron el antígeno del core del virus de Hepatitis B, los anticuerpos contra el virus linfotrópico de células T humanas 1-2, y sífilis, con 51,2 %, 16,8 % y 14,9 %, respectivamente. La seropositividad de los marcadores infecciosos se asoció con factores demográficos como la edad, sexo y lugar de procedencia (p< 0,05). Conclusiones: Existe relación entre los factores demográficos con la seropositividad de los marcadores infecciosos en donantes peruanos.


Introduction: The characteristics of blood donors may vary between hemotherapy centers and may be related to the seropositivity of infectious markers. Objective: To related the seropositivity of infectious markers with the demographic factors of Peruvian blood donors. Methods: Observational in the blood banks of the Hospital Nacional Cayetano Heredia and the Instituto Nacional Materno Perinatal during 2019. The population consisted of 11,936 donors who were screened for the seven infectious agents according to the National Hemotherapy and Blood Bank Program. Pearson's correlation test was used to determine the association between demographic variables and infectious markers. Results: Of the total, 8,449 (70.8%) were male and the age group from 35 to 55 years was the most frequent in both hospitals (~ 44.5%). Most donors came from the coast (4,944; 41.4 %), although at the Cayetano Heredia National Hospital, there were 734 (8.9%) from the jungle. Seropositivity was 507 (4.25%) donations, then most frequent was Hepatitis B virus core antigen, antibodies against human T-cell lymphotropic virus 1-2, and syphilis, with 51.2%, 16.8%, and 14.9%, respectively. Seropositivity of infectious markers was associated with demographic factors such as age, gender, and place of origin (p< 0.05). Conclusions: There is a relationship between demographic factors with the seropositivity of infectious markers in Peruvian donors.

8.
BMJ Open ; 13(12): e075070, 2023 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-38101848

RESUMO

INTRODUCTION: Transfusions in surgery can be life-saving interventions, but inappropriate transfusions may lack clinical benefit and cause harm. Transfusion decision-making in surgery is complex and frequently informed by haemoglobin (Hgb) measurement in the operating room. Point-of-care testing for haemoglobin (POCT-Hgb) is increasingly relied on given its simplicity and rapid provision of results. POCT-Hgb devices lack adequate validation in the operative setting, particularly for Hgb values within the transfusion zone (60-100 g/L). This study aims to examine the accuracy of intraoperative POCT-Hgb instruments in non-cardiac surgery, and the association between POCT-Hgb measurements and transfusion decision-making. METHODS AND ANALYSIS: PREMISE is an observational prospective method comparison study. Enrolment will occur when adult patients undergoing major non-cardiac surgery require POCT-Hgb, as determined by the treating team. Three concurrent POCT-Hgb results, considered as index tests, will be compared with a laboratory analysis of Hgb (lab-Hgb), considered the gold standard. Participants may have multiple POCT-Hgb measurements during surgery. The primary outcome is the difference in individual Hgb measurements between POCT-Hgb and lab-Hgb, primarily among measurements that are within the transfusion zone. Secondary outcomes include POCT-Hgb accuracy within the entire cohort, postoperative morbidity, mortality and transfusion rates. The sample size is 1750 POCT-Hgb measurements to obtain a minimum of 652 Hgb measurements <100 g/L, based on an estimated incidence of 38%. The sample size was calculated to fit a logistic regression model to predict instances when POCT-Hgb are inaccurate, using 4 g/L as an acceptable margin of error. ETHICS AND DISSEMINATION: Institutional ethics approval has been obtained by the Ottawa Health Science Network-Research Ethics Board prior to initiating the study. Findings from this study will be published in peer-reviewed journals and presented at relevant scientific conferences. Social media will be leveraged to further disseminate the study results and engage with clinicians.


Assuntos
Transfusão de Sangue , Hemoglobinas , Sistemas Automatizados de Assistência Junto ao Leito , Adulto , Humanos , Transfusão de Sangue/métodos , Canadá , Hemoglobinas/análise , Hospitais , Estudos Observacionais como Assunto
9.
Transfusion ; 63(11): 2170-2178, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37864539

RESUMO

BACKGROUND: Safe blood transfusion is an increasing priority in global health equity. The Global Health 2030 commission lists access to a safe blood supply as essential for all surgical and nonoperative patients. The objective of this study was to determine if Transfusion Camp, when modified through a collaborative partnership between experts in Canada and Rwanda, results in improved knowledge and confidence among trainees in a resource-limited setting in sub-Saharan Africa. METHODS: This prospective study took place at The University Teaching Hospital of Kigali in Rwanda. Participants were postgraduate medical trainees from departments where blood transfusion is frequent. Participants watched five prerecorded lectures and then attended a 5-hour team-based learning seminar to consolidate learning. Pre- and post-data were analyzed on transfusion knowledge and trainee confidence. A Rasch analysis investigated the performance of individual questions in assessing respondent knowledge. RESULTS: Of 31 trainees from surgery, anesthesia, internal medicine, and pediatrics invited to the course, 27 trainees attended the in-person team-based learning and 24 trainees completed the pre- and post-course analysis. Trainee knowledge assessment improved from (mean ± SD) 7.7/20 ± 1.95 to 10.4/20 ± 2.4 (p < .0001) and this knowledge was maintained by 12 trainees on a 3-month follow-up with a mean score of 9.3/20 ± 2.3. Trainees reported increased confidence in managing transfusion medicine-related patient issues. CONCLUSION: This pilot study demonstrated that Transfusion Camp education content modified to the local context can result in increased knowledge and confidence in managing transfusion-related issues. These results will inform future planning of Transfusion Camp in resource-limited settings.


Assuntos
Transfusão de Sangue , Competência Clínica , Humanos , Criança , Estudos Prospectivos , Ruanda , Projetos Piloto , Estudos de Viabilidade
10.
Clin Lab Med ; 43(4): 669-683, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37865510

RESUMO

Patients with MDS often suffer from anemia, and less often thrombocytopenia, and thus are a frequently transfused population. Red blood cell (RBC) transfusion may be used to improve functional capacity and quality of life in this population, while platelet transfusion is typically used to decrease bleeding risk. Despite the frequency of transfusion in patients with MDS, there are few well-defined guidelines for RBC and platelet transfusion support in this patient population. Transfusion is not without risk-patients with MDS who are frequently transfused may develop alloantibodies to RBC antigens, which can lead to hemolytic transfusion reactions and delays in obtaining compatible RBCs. Regular communication between clinicians and blood bank physicians is crucial to ensure that patients with MDS receive the most appropriate blood products.


Assuntos
Eritrócitos , Síndromes Mielodisplásicas , Humanos , Qualidade de Vida , Síndromes Mielodisplásicas/terapia , Transfusão de Sangue , Transfusão de Eritrócitos
11.
Hematol., Transfus. Cell Ther. (Impr.) ; 45(3): 342-349, July-Sept. 2023. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1514178

RESUMO

ABSTRACT Introduction: The knowledge of clinicians regarding blood transfusion services may impact patient care and transfusion outcome. The wide variation in transfusion practices among clinicians leads to inappropriate blood product usage and jeopardizes patient safety. Hence, this survey study aimed to assess knowledge, attitude and practice among the residents and interns of safe blood transfusion. Methods: The online survey was based on self-administered questionnaires of three sections: 1. Demography; 2. Knowledge, and; 3. Attitude and Practice. One point was assigned for the correct response of each question in every section. The knowledge score was further categorized into three categories, depending on the points obtained. The participants were also divided into four groups, depending on their experience. The Kruskal-Wallis test was applied to determine the difference of knowledge and practice scores in three designated groups of residents and interns. A p-value of less than 0.05 was considered to be significant. Result: A total of 247 residents and interns participated in this study. Thirteen participants had an incomplete response. Out of 234 participants, Senior Residents (SR), Junior Residents (JR), and interns were 70, 96 and 68 participants, respectively. The knowledge scores of interns were significantly low, as compared to SRs and JRs. Practice scores of interns were also significantly low, compared to the JRs. However, most of the residents and interns (85%) were aware of the pre-transfusion testing. Conclusion: Therefore, the mandatory incorporation of the transfusion medicine subject in the undergraduate curriculum can help the young budding doctors to better implement the patient blood management.

12.
BMJ Open ; 13(8): e073270, 2023 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-37620260

RESUMO

INTRODUCTION: Liver resection carries a high risk for extensive bleeding and need for blood transfusions, which is associated with significant negative impact on outcome. In malignant disease, the most common indication for surgery, it also includes increased risk for recurrence of cancer. Argipressin decreases liver and portal blood flow and may have the potential to reduce bleeding during liver surgery, although this has not been explored. METHOD AND ANALYSIS: ARG-01 is a prospective, randomised, placebo-controlled, double-blinded study on 248 patients undergoing liver resection at Sahlgrenska University Hospital, Sweden. Patients will be randomised to one of two parallel groups, infusion of argipressin or normal saline administered peroperatively. The primary endpoint is peroperative blood loss. Secondary outcomes include need for blood transfusion, perioperative variables, length of hospital stay, the inflammatory response, organ damage markers and complications at 30 days. ETHICS AND DISSEMINATION: The study is enrolling patients since March 2022. The trial is approved by the Swedish Ethical Review Authority (Dnr 2021-03557) and the Swedish Medical Product Agency (Dnr 5.1-2021-90115). Results will be announced at scientific meetings and in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05293041 and EudraCT, 2021-001806-32.


Assuntos
Arginina Vasopressina , Hepatectomia , Humanos , Estudos Prospectivos , Hepatectomia/efeitos adversos , Fígado , Projetos de Pesquisa , Hemorragia , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
Blood Rev ; 61: 101114, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37479599

RESUMO

Anemia is common in Myelodysplastic Syndromes (MDS). Different anemia treatments have been tested in clinical studies, but the full impact on patients' health-related quality of life (HRQoL) and physical function is unknown. The main aim of this review was to assess whether improvements in anemia are associated with changes in HRQoL/physical function. Twenty-six full-text publications were identified, enrolling 2211 patients: nine randomized trials (RCTs), fourteen non-randomized studies of interventions and three cross-sectional studies. Interventions included: growth factors/erythropoiesis-stimulating agents (n = 14), red cell transfusion (n = 9), erythroid maturation agents (n = 1), or a combination (n = 2). Five RCTs reported no changes in HRQoL despite erythroid response to the intervention, raising the question of whether anemia treatment alone can effectively improve HRQoL. Many studies were considered at high risk of bias for assessing HRQoL. There is a pressing need for future clinical trials to better define the nature of the relationship between anemia and HRQoL/functional outcomes.


Assuntos
Anemia , Hematínicos , Síndromes Mielodisplásicas , Humanos , Anemia/etiologia , Anemia/terapia , Síndromes Mielodisplásicas/complicações , Síndromes Mielodisplásicas/terapia , Hematínicos/uso terapêutico , Transfusão de Eritrócitos , Qualidade de Vida
14.
BMJ Open ; 13(7): e070272, 2023 07 24.
Artigo em Inglês | MEDLINE | ID: mdl-37487676

RESUMO

INTRODUCTION: Many extremely preterm newborns develop anaemia requiring a transfusion, with most receiving three to five transfusions during their admission. While transfusions save lives, the potential for transfusion-related adverse outcomes is an area of growing concern. Transfusion is an independent predictor of death and is associated with increased morbidity, length of hospital stay, risk of infection and immune modulation. The underlying mechanisms include adverse pro-inflammatory and immunosuppressive responses. Evidence supports an association between transfusion of washed red cells and fewer post-transfusion complications potentially through removal of chemokines, lipids, microaggregates and other biological response modifiers. However, the clinical and cost-effectiveness of washed cells have not been determined. METHODS AND ANALYSIS: This is a multicentre, randomised, double-blinded trial of washed versus unwashed red cells. Infants <28 weeks' gestation requiring a transfusion will be enrolled. Transfusion approaches will be standardised within each study centre and will occur as soon as possible with a recommended fixed transfusion volume of 15 mL/kg whenever the haemoglobin is equal to or falls below a predefined restrictive threshold, or when clinically indicated. The primary outcome is a composite of mortality and/or major morbidity to first discharge home, defined as one or more of the following: physiologically defined bronchopulmonary dysplasia; unilateral or bilateral retinopathy of prematurity grade >2, and; necrotising enterocolitis stage ≥2. To detect a 10% absolute reduction in the composite outcome from 69% with unwashed red blood cell (RBCs) to 59% with washed RBCs with 90% power, requires a sample size of 1124 infants (562 per group). Analyses will be performed on an intention-to-treat basis with a prespecified statistical analysis plan. A cost-effectiveness analysis will also be undertaken. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Women's and Children's Health Network Human Research Ethics Committee (HREC/12/WCHN/55). The study findings will be disseminated through peer-reviewed articles and conferences. TRIAL REGISTRATION NUMBER: ACTRN12613000237785 Australian New Zealand Clinical Trials Registry.


Assuntos
Saúde da Criança , Saúde da Mulher , Criança , Feminino , Lactente , Recém-Nascido , Humanos , Austrália , Eritrócitos , Transfusão de Sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
15.
Transfus Med Hemother ; 50(3): 198-207, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37408648

RESUMO

Background: Omics technologies represent a new analytical approach that allows a full cellular readout through the simultaneous analysis of thousands of molecules. The application of such technologies represents a flourishing field of research in human medicine, especially in transfusion medicine, while their application in veterinary medicine still needs to be developed. Summary: Omics technologies, especially proteomics, metabolomics, and lipidomics, are currently applied in several fields of human medicine. In transfusion medicine, the creation and integration of multiomics datasets have uncovered intricate molecular pathways occurring within blood bags during storage. In particular, the research has been directed toward the study of storage lesions (SLs), i.e., those biochemical and structural changes that red blood cells (RBCs) undergo during hypothermic storage, their causes, and the development of new strategies to prevent them. However, due to their challenges to perform and high costs, these technologies are hardly accessible to veterinary research, where their application dates back only to the last few years and thus a great deal of progress still needs to be made. As regards veterinary medicine, there are only a few studies that have focused mainly on fields such as oncology, nutrition, cardiology, and nephrology. Other studies have suggested omics datasets that provide important insights for future comparative investigations between human and nonhuman species. Regarding the study of storage lesions and, more generally, the veterinary transfusion field, there is a marked lack of available omics data and results with relevance for clinical practice. Key Messages: The use of omics technologies in human medicine is well established and has led to promising results in blood transfusion and related practices knowledge. Transfusion practice is a burgeoning field in veterinary medicine, but, to date, there are no species-specific procedures and techniques for the collection and storage of blood units and those validated in the human species are univocally pursued. Multiomics analysis of the species-specific RBCs' biological characteristics could provide promising results both from a comparative perspective, by increasing our understanding of species suitable to be used as animal models, and in a strictly veterinary view, by contributing to the development of animal-targeted procedures.

16.
BMJ Open ; 13(6): e073341, 2023 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-37286322

RESUMO

INTRODUCTION: Perioperative coagulopathy is common in patients undergoing aortic surgery, increasing the risk of excessive blood loss and subsequent allogeneic transfusion. Blood conservation has become a vital part of cardiovascular surgery, but measures to protect platelets from destruction by cardiopulmonary bypass (CPB) are still lacking. Autologous platelet concentrate (APC) may have potential benefits for intraoperative blood preservation, but its efficacy has not been studied extensively. This study aims to evaluate the efficacy of APC as a blood conservation technique to reduce blood transfusion in adult aortic surgery. METHODS AND ANALYSIS: This is a prospective, single-centre, single-blind randomised controlled trial. A total of 344 adult patients undergoing aortic surgery with CPB will be enrolled and randomised to either the APC group or the control group with a 1:1 randomisation ratio. Patients in the APC group will receive autologous plateletpheresis before heparinisation, while those in the control group will not. The primary outcome is the perioperative packed red blood cell (pRBC) transfusion rate. Secondary endpoints include the volume of perioperative pRBC transfusion; drainage volume within 72 hours post-surgery; postoperative coagulation and platelet function; and the incidence of adverse events. Data will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: This study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (no. 2022-1806). All procedures included in this study will be performed in adherence to the Helsinki Declaration. The results of the trial will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Register (ChiCTR2200065834).


Assuntos
Transfusão de Sangue , Plaquetoferese , Humanos , Adulto , Estudos Prospectivos , Método Simples-Cego , Ponte Cardiopulmonar , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
BMJ Open ; 13(5): e071547, 2023 05 26.
Artigo em Inglês | MEDLINE | ID: mdl-37236666

RESUMO

INTRODUCTION: Fibrinogen is one of the essential coagulation factors. Preoperative lower plasma fibrinogen level has been associated with higher blood loss. Scoliosis surgery presents a challenge for the anaesthetic team, one of the reasons being blood loss and transfusion management. Recently, the prophylactic fibrinogen administration has been a debated topic in various indications. It has been described for example, in urological or cardiovascular surgery, as well as in paediatrics. This pilot study is focused on verifying the feasibility of potential large randomised trial and verifying the safety of prophylactic fibrinogen administration in paediatric scoliosis surgery. METHODS AND ANALYSIS: A total of 32 paediatric patients indicated for scoliosis surgery will be recruited. Participants will be randomised into study groups in a 1:1 allocation ratio. Patients in the intervention group will receive prophylactic single dose of fibrinogen, in addition to standard of care. Patients in the control group will receive standard of care without study medication prior to skin incision. The primary aim is to assess the safety of prophylactic fibrinogen administration during scoliosis surgery in children, the incidence of any adverse events (AEs) and reactions will be monitored during participation in the study. The secondary objective is to investigate the additional safety information, feasibility and efficacy of a prophylactic fibrinogen administration. The incidence of AEs and reactions according to selected adverse events of special interest will be monitored. All collected data will be subjected to statistical analysis according to a separate statistical analysis plan. ETHICS AND DISSEMINATION: This trial follows the applicable legislation and requirements for good clinical practice according to the International Conference on Harmonisation E6(R2). All essential trial documents were approved by the relevant ethics committee and national regulatory authority (State Institute for Drug Control) and their potential amendments will be submitted for approval. TRIAL REGISTRATION NUMBER: NCT05391412.


Assuntos
Hemostáticos , Escoliose , Humanos , Criança , Fibrinogênio/uso terapêutico , Escoliose/cirurgia , Projetos Piloto , Hemostáticos/uso terapêutico , Hemorragia/prevenção & controle , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Transfus Med ; 33(4): 337-348, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37170673

RESUMO

Cardiac surgery is associated with numerous peri- and post-operative haemostatic complications and blood transfusion requirements. Complex procedures such as redo-sternotomy heart transplantation or type A aortic dissection repairs are at high-risk for severe coagulopathy and significant transfusion requirements. However, current practice guidelines do not specifically address high-risk surgeries, resulting in variable practice. To optimise outcomes, a multidisciplinary approach to blood transfusion and haemostasis is critical. How individual institutions construct these multidisciplinary teams, delegate responsibilities, and build procedures may differ depending on the institution and availability of resources. In this article, we compare how the transfusion medicine services support their cardiac surgery and transplant programs at three large medical centres-Vanderbilt University Medical Center (the largest heart transplant centre in the world by volume in 2021), Toronto General Hospital-University Health Network (a quaternary-care centre in Canada's most populous city, performing more >20 heart transplants annually), and Vancouver General Hospital (a quaternary-care centre that performs numerous high-risk cardiac surgeries). This article discusses management from multiple perspectives, including the blood bank and perioperative environments, and highlights how institutions have evolved their programs in accordance with nation-specific policies and provisions.


Assuntos
Transtornos da Coagulação Sanguínea , Procedimentos Cirúrgicos Cardíacos , Humanos , Transfusão de Sangue/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , América do Norte , Hemostasia
19.
Comp Immunol Microbiol Infect Dis ; 97: 101982, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37120937

RESUMO

Hemotropic mycoplasmas are associated with subclinical disease in dogs and should be identified in blood donors. The objective was to investigate the presence and effect of M. haemocanis in units of packed red blood cells (pRBC) during storage. Canine donors (n = 10) were screened for M. haemocanis by quantitative real-time PCR. pRBCs were obtained from 5 hemoplasma negative dogs and 5 hemoplasma positive dogs. Each pRBC was aliquoted into two 100 mL transfer bags and stored at 4 °C. M. haemocanis loads and biochemical variables (pH, bicarbonate, potassium, sodium, chlorite, glucose, lactate, ammonia, PCV, and % hemolysis) were evaluated on days 1, 7, 18, and 29. M. haemocanis loads increased in pRBC from day 1-29 of storage. Glucose decreased and lactate increase faster in pRBC with M. haemocanis. This study contributes to understand hemoplasma metabolism and reinforces that dog donors should be tested for hemoplasmas.


Assuntos
Doenças do Cão , Infecções por Mycoplasma , Mycoplasma , Cães , Animais , Eritrócitos , Glucose/farmacologia , Infecções por Mycoplasma/veterinária
20.
Educ. med. super ; 37(1)mar. 2023. tab
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1440011

RESUMO

Introducción: Para una práctica transfusional segura se requiere una formación en medicina transfusional. Objetivo: Determinar la manera en que se integran los contenidos y las habilidades de medicina transfusional en la formación y la especialización médica en Cuba. Métodos: Se hizo un estudio educacional, analítico, de corte transversal en la Universidad de Ciencias Médicas de Camagüey, desde marzo de 2020 hasta julio de 2021. Se realizó un análisis documental para precisar cómo se integraban los contenidos y las habilidades de medicina transfusional al currículo para la formación de médicos, a los programas de estudio del internado vertical en 26 especialidades médicas, y a 29 planes de estudio y programas de especialización en Cuba. Resultados: El currículo para la formación de médicos en Cuba no incluye medicina transfusional. La asignatura que más contribuye a la formación en esta área del saber es Sangre y Sistema inmune. Los contenidos y las habilidades de medicina transfusional solo se incluyen expresamente en nueve programas de estudio del internado vertical y en 12 planes de estudio y programas de especialización. Conclusiones: Existe una insuficiente integración de los contenidos y las habilidades de medicina transfusional en el currículo de la carrera de medicina en Cuba, situación que se manifiesta también en los programas de estudios de los internados verticales y en la mayoría de los programas de las especialidades médicas.


Introduction: Safe transfusion practice requires training in transfusion medicine. Objective: To determine the way in which transfusion medicine contents and skills are integrated into medical training and specialization in Cuba. Methods: An educational, analytical and cross-sectional study was carried out at Universidad de Ciencias Médicas de Camagüey, from March 2020 to July 2021. A documentary analysis was conducted to determine how transfusion medicine contents and skills were integrated into the curriculum for the training of physicians, into the study programs of the vertical internship in 26 medical specialties, as well as into 29 study plans and specialization programs in Cuba. Results: The curriculum for the training of physicians in Cuba does not include transfusion medicine. The subject that most contributes to training in this area of knowledge is Blood and Immune System. Transfusion medicine contents and skills are only expressly included in nine vertical internship study programs and in twelve study plans and specialization programs. Conclusions: There is insufficient integration of transfusion medicine contents and skills in the Cuban medical major curriculum, a situation that is also manifested in the study programs of vertical internships and in most of the medical specialties programs.


Assuntos
Humanos , Currículo , Capacitação Profissional , Estudos Transversais , Educação Médica , Educação de Pós-Graduação em Medicina , Programas de Pós-Graduação em Saúde , Medicina
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