Ensayo clínico para determinar si el momento de administración del ácido tranexámico en la cirugía de prótesis total de rodilla con torniquete influye en el sangrado perioperatorio / Clinical trial to determine whether the timing of tranexamic acid administration influences perioperative bleeding in total knee arthroplasty

Antecedentes y objetivos: El momento óptimo para la administración de ácido tranexámico en la artroplastia de rodilla con torniquete no está claro. El objetivo principal de nuestro estudio era demostrar si su administración tras la inducción anestésica reduce el sangrado postoperatorio respecto a administrarlo antes de la liberación del torniquete. Nuestro objetivo secundario era determinar si una segunda dosis reduce significativamente el sangrado. Material y métodos: Ensayo clínico prospectivo con 212 pacientes programados para prótesis total de rodilla, aleatorizados en 4 grupos. El ácido tranexámico se administró antes de la isquemia en los «grupos preinducción» (1 y 2) y justo antes de la liberación del torniquete en los «grupos preliberación» (3 y 4). Los grupos 2 y 4 recibieron una segunda dosis 3h después. La variable principal fue el sangrado postoperatorio (visible y el calculado). Las variables secundarias fueron la variación de hemoglobina, complicaciones y transfusión. Resultados: El sangrado total calculado fue 1563ml (IC 95%: 1445-1681) en los grupos preinducción frente a 1576ml (IC 95%: 1439-1713) en los preliberación (p=0,9); los de dosis única sangraron 1579ml (IC 95%: 1452-1706) frente a 1559ml (IC 95%: 1431-1686) en los de 2 dosis (p=0,82). La hemoglobina al alta fue 10,4 (IC 95%: 10,2-10,7) con una dosis frente a 10,8g/dl (IC 95%: 10,6-11,1) con 2 dosis (p=0,06). Conclusiones: No se detectaron diferencias en sangrado ni transfusión dependiendo del momento de administración del ácido tranexámico. Una segunda dosis tampoco tuvo impacto significativo.(AU)

Background and objectives: The ideal timing of tranexamic acid administration in total knee arthroplasty with tourniquet remains unclear. Our primary objective was to prove if administering it before surgical incision, instead of before releasing the tourniquet, reduces postoperative bleeding. A second objective was to determine whether a second dose reduces post-operative bleeding. Material and methods: A prospective, double-blind clinical trial was performed on 212 patients scheduled for total knee arthroplasty. They were randomised into 4 groups. Tranexamic acid was administered before the surgical incision in “pre-induction groups” (1 and 2), and just before the tourniquet release in “pre-release groups” (3 and 4). Groups 2 and 4 received a second dose 3hours post-surgery. Main outcome was postoperative bleeding (visible blood loss and calculated total bleeding). Secondary outcomes were haemoglobin variations, complications and transfusion rate. Results: The mean calculated total bleeding was 1563ml (95%CI: 1445 to 1681) in preinduction groups versus 1576ml (95%CI: 1439 to 1713) in pre-release groups (P=.9); 1579ml (95%CI: 1452 to 1706) in single-dose groups versus 1559ml (95%CI: 1431 to 1686) in double-dose groups (P=.82). One patient was transfused. The mean haemoglobin at discharge was 10.4g/dl (95%CI: 10.2 to 10.7) in singledose groups versus 10.8 (95%CI: 10.6 to 11.1) in double-dose groups (P=.06). Conclusions: There were no differences in bleeding or transfusion regarding the time of tranexamic acid administration. The second dose had not impact on outcomes.(AU)

Clinical trial to determine whether the timing of tranexamic acid administration influences perioperative bleeding in total knee arthroplasty.

BACKGROUND AND OBJECTIVES: The ideal timing of tranexamic acid administration in total knee arthroplasty with tourniquet remains unclear. Our primary objective was to prove if administering it before surgical incision, instead of before releasing the tourniquet, reduces postoperative bleeding. A second objective was to determine whether a second dose reduces post-operative bleeding. MATERIAL AND METHODS: A prospective, double-blind clinical trial was performed on 212 patients scheduled for total knee arthroplasty. They were randomised into 4 groups. Tranexamic acid was administered before the surgical incision in "pre-induction groups" (1 and 2), and just before the tourniquet release in "pre-release groups" (3 and 4). Groups 2 and 4 received a second dose 3h post-surgery. Main outcome was postoperative bleeding (visible blood loss and calculated total bleeding). Secondary outcomes were haemoglobin variations, complications and transfusion rate. RESULTS: The mean calculated total bleeding was 1563ml (95%CI: 1445-1681) in preinduction groups versus 1576ml (95%CI: 1439-1713) in pre-release groups (P=0.9); 1579ml (95%CI: 1452-1706) in single-dose groups versus 1559ml (95%CI: 1431-1686) in double-dose groups (P=0.82). One patient was transfused. The mean haemoglobin at discharge was 10.4g/dl (95%CI: 10.2-10.7) in singledose groups versus 10.8 (95%CI: 10.6-11.1) in double-dose groups (P=0.06). CONCLUSIONS: There were no differences in bleeding or transfusion regarding the time of tranexamic acid administration. The second dose had not impact on outcomes. TRIAL REGISTRATION: EudraCT 2016-000071-24.

[Health policy strategies for Patient Blood Management implementation throughout the Spanish health systems]. / Estrategias de gestión y política sanitaria para el desarrollo del Patient Blood Management en los sistemas de salud en España.

Patient Blood Management (PBM) programs have proven to be successful in reducing overuse and improving patient safety, clinical outcomes and efficiency. Despite its benefits, PBM is still scarcely used in real clinical practice with a high variability among hospitals in Spain. Recent guidelines from the European Union on how to implement PBM, as well as recommendations from experts in the field, suggest that further development in PBM implementation requires not only the participation of healthcare professionals but also the commitment and support of Health Authorities and senior hospital management. This article provides some thoughts on health care management and policy strategies to help implement PBM throughout the Spanish autonomous healthcare systems.

Patient Blood Management en artroplastia primaria de cadera y rodilla. Encuesta entre los investigadores del estudio POWER.2 / Patient Blood Management for primary hip and knee replacement. A survey among POWER.2 study researchers

ANTECEDENTES: La implementación de los programas Patient Blood Management (PBM) es variable en Europa, incluso en centros en los que estos programas están bien establecidos, donde existe variabilidad en cuanto a prácticas transfusionales. OBJETIVOS Y MÉTODOS: Realizamos una encuesta para valorar la práctica actual sobre PBM perioperatoria en pacientes programados para artroplastia total de cadera y rodilla, entre los investigadores involucrados en el Estudio POWER.2 en España (estudio observacional prospectivo que evaluaba las vías de recuperación intensificada en cirugía ortopédica). RESULTADOS: Se obtuvo un total de 322 respuestas (37,8%). El 50% de los respondedores revisaban los niveles de hemoglobina, al menos 4 semanas antes de la cirugía; el 35% trataba a todos los pacientes anémicos, aunque el 99,7% consideraba que la detección y tratamiento de la anemia preoperatoria podrían influir en los resultados postoperatorios. La falta de infraestructuras (76%) y la falta de tiempo (51%) fueron los principales motivos para no tratar a los pacientes anémicos. El estatus del hierro es revisado antes de la cirugía por el 19% de manera rutinaria, y el 36% lo evalúa únicamente en pacientes anémicos. Hb<9,9g/dl es el valor umbral para demorar la cirugía para el 61% de los clínicos, y el 22% consideraría transfundir preoperatoriamente a los pacientes clínicamente estables sin sangrado activo. El valor umbral para transfundir a los pacientes sin enfermedad cardiovascular es 8g/dl para el 43% y 7g/dl para el 34% de los respondedores; el 75% de los facultativos considera que utiliza «umbrales restrictivos», y el 90% sigue la política transfusional uno a uno (single unit). CONCLUSIONES: Los resultados de nuestra encuesta muestran la variabilidad en la práctica clínica en PBM en cirugía ortopédica mayor, a pesar de ser el tipo de cirugía con más tradición en estos programas

BACKGROUND: Implementation of Patient Blood Management programs remain variable in Europe, and even in centres with well-established PBM programs variability exists in transfusion practices. OBJECTIBES AND METHODS: We conducted a survey in order to assess current practice in perioperative Patient Blood Management in patients undergoing total hip and knee replacement among researchers involved in POWER.2 Study in Spain (an observational prospective study evaluating enhanced recovery pathways in orthopaedic surgery). RESULTS: A total of 322 responses were obtained (37.8%). Half of responders check Haemoglobin levels in patients at least 4 weeks before surgery; 35% treat all anaemic patients, although 99.7% consider detection and treatment of preoperative anaemia could influence the postoperative outcomes. Lack of infrastructure (76%) and lack of time (51%) are the main stated reasons not to treat anaemic patients. Iron status is routinely checked by 19% before surgery, and 36% evaluate it solely in the anaemic patient. Hb<9.9 g/dl is the threshold to delay surgery for 61% of clinicians, and 22% would consider transfusing preoperatively clinically stable patients without active bleeding. The threshold to transfuse patients without cardiovascular disease is 8 g/dl for 43%, and 7 g/dl for 34% of the responders; 75% of clinicians consider they use "restrictive thresholds", and 90% follow the single unit transfusion policy. CONCLUSIONS: The results of our survey show variability in clinical practice in Patient Blood Management in major orthopaedic surgery, despite being the surgery with the greatest tradition in these programs

Patient Blood Management for primary hip and knee replacement. A survey among POWER.2 study researchers. / Patient Blood Management en artroplastia primaria de cadera y rodilla. Encuesta entre los investigadores del estudio POWER.2.

BACKGROUND: Implementation of Patient Blood Management programs remain variable in Europe, and even in centres with well-established PBM programs variability exists in transfusion practices. OBJECTIVES AND METHODS: We conducted a survey in order to assess current practice in perioperative Patient Blood Management in patients undergoing total hip and knee replacement among researchers involved in POWER.2 Study in Spain (an observational prospective study evaluating enhanced recovery pathways in orthopaedic surgery). RESULTS: A total of 322 responses were obtained (37.8%). Half of responders check Haemoglobin levels in patients at least 4 weeks before surgery; 35% treat all anaemic patients, although 99.7% consider detection and treatment of preoperative anaemia could influence the postoperative outcomes. Lack of infrastructure (76%) and lack of time (51%) are the main stated reasons not to treat anaemic patients. Iron status is routinely checked by 19% before surgery, and 36% evaluate it solely in the anaemic patient. Hb<9.9 g/dl is the threshold to delay surgery for 61% of clinicians, and 22% would consider transfusing preoperatively clinically stable patients without active bleeding. The threshold to transfuse patients without cardiovascular disease is 8 g/dl for 43%, and 7 g/dl for 34% of the responders; 75% of clinicians consider they use "restrictive thresholds", and 90% follow the single unit transfusion policy. CONCLUSIONS: The results of our survey show variability in clinical practice in Patient Blood Management in major orthopaedic surgery, despite being the surgery with the greatest tradition in these programs.

Valoración del grado de conocimiento de los profesionales sobre el Patient Blood Management en su organización. Modelo y resultados de la encuesta del proyecto MAPBM / Assessment of the knowledge level of the professional as regards Patient Blood Management in their organisation. Results of the MAPBM project survey

Introducción: El proyecto Maturity Assessment Model in Patient Blood Management consiste en la aplicación de una matriz que evalúa la madurez del centro sobre la adecuación de su práctica transfusional. Esta herramienta incluye una encuesta dirigida a los profesionales sobre el grado de conocimiento del Patient Blood Management en su centro. Material y métodos: Durante 2016, 41 hospitales estuvieron asociados al proyecto Maturity Assessment Model in Patient Blood Management. La encuesta constaba de 10 preguntas, 3 sobre centro, especialidad y años de experiencia, y 7 sobre el conocimiento del Patient Blood Management. El número mínimo de respuestas por centro fue asignado según el número de camas. Se requería de un mínimo de respuestas de al menos 3 especialidades diferentes para poder ser evaluado. Resultados: El total de encuestas contestadas fue de 1403. La especialidad de mayor respuesta fue anestesiología (40,9%). La distribución respecto a experiencia profesional fue:<10 años 33,4%, 10-20 años 33% y >20 años 33,6%. Un 74,2% conocía el programa Patient Blood Management en su centro y un 60,7% conocía el protocolo de tratamiento de la anemia preoperatoria. El 72% refería conocer el protocolo de transfusión sanguínea de su centro y un 90% consideraba otros factores además del valor de la hemoglobina para la decisión de transfusión. Solo un 30,7% de los profesionales afirmó recibir información periódica sobre la práctica transfusional. Conclusiones: Se observó una falta significativa de conocimiento sobre los protocolos de tratamiento de la anemia y el protocolo transfusional de sus centros. En la actualidad pocos centros comunican datos sobre práctica transfusional

Introduction: The Maturity Assessment Model in Patient Blood Management project involves the use of a matrix that evaluates the maturity of the centre as regards blood transfusion practice. This tool includes a questionnaire to be completed by physicians to determine their level of knowledge of patient blood management strategies in their centre. Material and methods: Forty one hospitals took part in the Maturity Assessment Model in Patient Blood Management project in 2016. The questionnaire included 10 questions, 3 about the centre, specialty, and years of experience, and 7 about patient blood management protocols in the respondent's centre. The minimum responses required per centre was calculated according to the number of beds. Responses from at least 3 different specialties were required in order to be evaluated. Results: A total of 1403 questionnaires were completed. The specialty with the highest completion rate was anaesthesiology (40.9%). The distribution as regards professional experience was homogeneous: <10 years, 33.4%, 10-20 years, 33%, and> 20 years 33.6%. Nearly three-quarters (74.2%) knew the patient blood management protocol used in their centre, and 60.7% knew the protocol for the treatment of pre-operative anaemia. Slightly fewer (72%) reported knowing the blood transfusion protocol (transfusion threshold) used in their centre, and 90% considered other factors besides haemoglobin in the decision to transfuse. Only 30.7% of professionals reported receiving periodic information on transfusion practices. Conclusions: There is a significant lack of knowledge about preoperative anaemia and perioperative transfusion protocols used in the centres polled. Few centres provide their physicians with information on transfusion practices

Assessment of the knowledge level of the professional as regards Patient Blood Management in their organisation. Results of the MAPBM project survey. / Valoración del grado de conocimiento de los profesionales sobre el Patient Blood Management en su organización. Modelo y resultados de la encuesta del proyecto MAPBM.

INTRODUCTION: The Maturity Assessment Model in Patient Blood Management project involves the use of a matrix that evaluates the maturity of the centre as regards blood transfusion practice. This tool includes a questionnaire to be completed by physicians to determine their level of knowledge of patient blood management strategies in their centre. MATERIAL AND METHODS: Forty one hospitals took part in the Maturity Assessment Model in Patient Blood Management project in 2016. The questionnaire included 10 questions, 3 about the centre, specialty, and years of experience, and 7 about patient blood management protocols in the respondent's centre. The minimum responses required per centre was calculated according to the number of beds. Responses from at least 3 different specialties were required in order to be evaluated. RESULTS: A total of 1403 questionnaires were completed. The specialty with the highest completion rate was anaesthesiology (40.9%). The distribution as regards professional experience was homogeneous: <10 years, 33.4%, 10-20 years, 33%, and> 20 years 33.6%. Nearly three-quarters (74.2%) knew the patient blood management protocol used in their centre, and 60.7% knew the protocol for the treatment of pre-operative anaemia. Slightly fewer (72%) reported knowing the blood transfusion protocol (transfusion threshold) used in their centre, and 90% considered other factors besides haemoglobin in the decision to transfuse. Only 30.7% of professionals reported receiving periodic information on transfusion practices. CONCLUSIONS: There is a significant lack of knowledge about preoperative anaemia and perioperative transfusion protocols used in the centres polled. Few centres provide their physicians with information on transfusion practices.

An international consensus statement on the management of postoperative anaemia after major surgical procedures.

Despite numerous guidelines on the management of anaemia in surgical patients, there is no pragmatic guidance for the diagnosis and management of anaemia and iron deficiency in the postoperative period. A number of experienced researchers and clinicians took part in a two-day expert workshop and developed the following consensus statement. After presentation of our own research data and local policies and procedures, appropriate relevant literature was reviewed and discussed. We developed a series of best-practice and evidence-based statements to advise on patient care with respect to anaemia and iron deficiency in the postoperative period. These statements include: a diagnostic approach to iron deficiency and anaemia in surgical patients; identification of patients appropriate for treatment; and advice on practical management and follow-up that is easy to implement. Available data allow the fulfilment of the requirements of Pillar 1 of Patient Blood Management. We urge national and international research funding bodies to take note of these recommendations, particularly in terms of funding large-scale prospective, randomised clinical trials that can most effectively address the important clinical questions and this clearly unmet medical need.

Randomized trial comparing ferric carboxymaltose vs oral ferrous glycine sulphate for postoperative anaemia after total knee arthroplasty.

BACKGROUND: Despite preoperative anaemia treatment, a risk of postoperative anaemia remains. This randomized, controlled study evaluated the efficacy of i.v. ferric carboxymaltose (FCM) as postoperative anaemia treatment after total knee arthroplasty (TKA). METHODS: TKA patients with postoperative anaemia [haemoglobin (Hb) 8.5-12.0 g dl(-1)] without prior transfusions were randomly assigned to FCM [700-1000 mg iron (according to calculate iron deficit on postoperative day 2)] or ferrous glycine sulphate (FS; 100 mg iron daily from day 7 onwards) and followed for Hb, iron status, quality-of-life (EQ-5D), and performance (6 min walk test) until day 30. RESULTS: Of 161 preoperatively non-anaemic patients, 122 (75.8%) developed anaemia after operation (within 24 h) and were enrolled in this study (60 FCM, 62 FS). Hb substantially decreased until day 4 in both groups, and partly recovered by day 30. FCM-treated patients achieved Hb ≥12.0 g dl(-1) more frequently (42.3% vs 23.5%; P=0.04) and showed a trend towards higher Hb increase from day 4 to day 30 [+1.7 (1.2) vs +1.3 (1.0); P=0.075] compared with FS-treated patients. Patients with postoperative Hb <10 g dl(-1) experienced better Hb increase with FCM [+2.4 (0.3) g dl(-1)] than FS [+1.1 (0.4) g dl(-1); P=0.018]. Patients being iron-deficient at enrolment (56.7%) had a higher Hb increase with FCM [+1.9 (0.3) g dl(-1)] than FS [+1.2 (0.2) g dl(-1); P=0.03]. Total EQ-5D and performance outcomes were comparable between the groups, but FCM was associated with better scores for 'usual activities'. No i.v. iron-related adverse events were reported. CONCLUSIONS: Preoperatively non-anaemic TKA patients are at high risk of postoperative anaemia. Postoperative i.v. FCM provided significant benefit over oral FS, particularly in patients with preoperative iron deficiency, severe postoperative anaemia, or both. CLINICAL TRIAL REGISTRATION: EudraCT 2010-023038-22; ClinicalTrials.gov NCT01913808.

2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla / The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document

La transfusión de sangre alogénica (TSA) no es inocua, y como consecuencia han surgido múltiples alternativas a la misma (ATSA). Existe variabilidad respecto a las indicaciones y buen uso de las ATSA. Dependiendo de la especialidad de los médicos que tratan a los pacientes, el grado de anemia, la política transfusional, la disponibilidad de las ATSA y el criterio personal, estas se usan de forma variable. Puesto que las ATSA tampoco son inocuas y pueden no cumplir criterios de coste-efectividad, la variabilidad en su uso es inaceptable. Las sociedades españolas de Anestesiología y Reanimación (SEDAR), Hematología y Hemoterapia(SEHH), Farmacia Hospitalaria (SEFH), Medicina Intensiva y Unidades Coronarias(SEMICYUC), Trombosis y Hemostasia (SETH) y Transfusiones Sanguíneas (SETS) han elaborado un documento de consenso para el buen uso de la ATSA. Un panel de expertos de las 6sociedades ha llevado a cabo una revisión sistemática de la literatura médica y elaborado el 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Solo se contempla las ATSA dirigidas a disminuir la transfusión de concentrado de hematíes. Se definen las ATSA como toda medida farmacológica y no farmacológica encaminada a disminuir la transfusión de concentrado de hematíes, preservando siempre la seguridad del paciente. La cuestión principal que se plantea en cada ítem se formula, en forma positiva o negativa, como: “La ATSA en cuestión reduce/no reduce la tasa transfusional». Para formular el grado de recomendación se ha usado la metodología Grades of Recommendation Assessment, Development and Evaluation (GRADE) (AU)

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH)and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: “Does this particular AABT reduce the transfusion rate or not? “All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation(GRADE) methodology (AU)

2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla / The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document

La transfusión de sangre alogénica (TSA) no es inocua, y como consecuencia han surgido múltiples alternativas a la misma (ATSA). Existe variabilidad respecto a las indicaciones y buen uso de las ATSA. Dependiendo de la especialidad de los médicos que tratan a los pacientes, el grado de anemia, la política transfusional, la disponibilidad de las ATSA y el criterio personal, estas se usan de forma variable. Puesto que las ATSA tampoco son inocuas y pueden no cumplir criterios de coste-efectividad, la variabilidad en su uso es inaceptable. Las sociedades españolas de Anestesiología y Reanimación (SEDAR), Hematología y Hemoterapia (SEHH), Farmacia Hospitalaria (SEFH), Medicina Intensiva y Unidades Coronarias (SEMICYUC), Trombosis y Hemostasia (SETH) y Transfusiones Sanguíneas (SETS) han elaborado un documento de consenso para el buen uso de la ATSA. Un panel de expertos de las 6 sociedades ha llevado a cabo una revisión sistemática de la literatura médica y elaborado el 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Solo se contempla las ATSA dirigidas a disminuir la transfusión de concentrado de hematíes. Se definen las ATSA como toda medida farmacológica y no farmacológica encaminada a disminuir la transfusión de concentrado de hematíes, preservando siempre la seguridad del paciente. La cuestión principal que se plantea en cada ítem se formula, en forma positiva o negativa, como: «La ATSA en cuestión reduce/no reduce la tasa transfusional». Para formular el grado de recomendación se ha usado la metodología Grades of Recommendation Assessment, Development and Evaluation (GRADE) (AU)

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: "Does this particular AABT reduce the transfusion rate or not?" All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology (AU)

[The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document]. / 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla.

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: « Does this particular AABT reduce the transfusion rate or not?¼ All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology.

[The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document]. / 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla.

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: "Does this particular AABT reduce the transfusion rate or not?" All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology.

Detection, evaluation, and management of preoperative anaemia in the elective orthopaedic surgical patient: NATA guidelines.

Previously undiagnosed anaemia is common in elective orthopaedic surgical patients and is associated with increased likelihood of blood transfusion and increased perioperative morbidity and mortality. A standardized approach for the detection, evaluation, and management of anaemia in this setting has been identified as an unmet medical need. A multidisciplinary panel of physicians was convened by the Network for Advancement of Transfusion Alternatives (NATA) with the aim of developing practice guidelines for the detection, evaluation, and management of preoperative anaemia in elective orthopaedic surgery. A systematic literature review and critical evaluation of the evidence was performed, and recommendations were formulated according to the method proposed by the Grades of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. We recommend that elective orthopaedic surgical patients have a haemoglobin (Hb) level determination 28 days before the scheduled surgical procedure if possible (Grade 1C). We suggest that the patient's target Hb before elective surgery be within the normal range, according to the World Health Organization criteria (Grade 2C). We recommend further laboratory testing to evaluate anaemia for nutritional deficiencies, chronic renal insufficiency, and/or chronic inflammatory disease (Grade 1C). We recommend that nutritional deficiencies be treated (Grade 1C). We suggest that erythropoiesis-stimulating agents be used for anaemic patients in whom nutritional deficiencies have been ruled out, corrected, or both (Grade 2A). Anaemia should be viewed as a serious and treatable medical condition, rather than simply an abnormal laboratory value. Implementation of anaemia management in the elective orthopaedic surgery setting will improve patient outcomes.

[Usefulness of activated recombinant factor VII for controlling massive bleeding: 4 years' experience in a university hospital]. / Utilidad del factor VII recombinante para el control de la hemorragia masiva. Experiencia de cuatro años en un centro hospitalario universitario.

OBJECTIVE: Massive bleeding that cannot be controlled by the usual means, such as transfusion, is a serious medical problem with high associated mortality. Our aim was to assess the efficacy and safety of treatment with activated recombinant factor VII (rFVIIa) to control massive bleeding after the failure of other methods. PATIENTS AND METHODS: This was a retrospective study of all cases of rFVIIa-treated massive bleeding in patients without a history of coagulation disorder from January 2003 through June 2007. RESULTS: The prevalence of rFVIIa treatment for this indication was 1 in 5200 hospitalized patients. Thirty patients were treated. Bleeding was reduced or stopped in 80% and consumption of blood products was reduced after administration of rFVIIa. Mortality was 43% and death was due to continued bleeding in 5 cases. No deaths were due to thromboembolism. CONCLUSIONS: rFVIIa is efficacious for controlling bleeding and reducing transfusion requirements in cases of massive hemorrhage, but mortality unrelated to bleeding is high in patients experiencing this complication. Further study is needed to better assess the utility, dosing, and ideal timing in the use of this drug.

Utilidad del factor VII recombinante para el controlde la hemorragia masiva. Experiencia de cuatro añosen un centro hospitalario universitario / No disponible

OBJETIVO: La hemorragia masiva no controlada pese alas medidas terapéuticas habituales como el soporte transfusional,supone un grave problema médico y tiene unaelevada mortalidad. El objetivo del trabajo ha sido evaluarla eficacia y seguridad del tratamiento con factor VII activadorecombinante (rFVIIa) en el control de la hemorragiamasiva, cuando las demás medidas han fracasado.PACIENTES Y MÉTODOS: Estudio retrospectivo de todoslos casos de hemorragia masiva en pacientes sin transtornoprevio de la coagulación, que fueron tratados conrFVIIa en nuestro centro desde enero de 2003 a junio de2007.RESULTADOS: La prevalencia de uso de rFVIIa con estaindicación ha sido de 1/5.200 pacientes hospitalizados. Sehan tratado 30 pacientes de los cuales el sangrado se redujoo paró en el 80% de los casos, con una disminución deluso de hemoderivados tras la administración de rFVIIa.La mortalidad fue del 43%, 5 casos por persistencia delsangrado, pero ninguna muerte fue por proceso tromboembólico.CONCLUSIONES: El rFVIIa resulta eficaz en el control delsangrado y en reducir los requerimientos transfusionalesen la hemorragia masiva, pero la mortalidad en estospacientes por causa no hemorrágica es alta. Son necesariosmás estudios para evaluar mejor la utilidad, dosificación ymomento idóneo de administración de este fármaco (AU)

OBJECTIVE: Massive bleeding that cannot be controlledby the usual means, such as transfusion, is a seriousmedical problem with high associated mortality. Our aimwas to assess the efficacy and safety of treatment withactivated recombinant factor VII (rFVIIa) to controlmassive bleeding after the failure of other methods.PATIENTS AND METHODS: This was a retrospective studyof all cases of rFVIIa-treated massive bleeding in patientswithout a history of coagulation disorder from January2003 through June 2007.RESULTS: The prevalence of rFVIIa treatment for thisindication was 1 in 5200 hospitalized patients. Thirtypatients were treated. Bleeding was reduced or stopped in80% and consumption of blood products was reducedafter administration of rFVIIa. Mortality was 43% anddeath was due to continued bleeding in 5 cases. No deathswere due to thromboembolism.CONCLUSIONS: rFVIIa is efficacious for controllingbleeding and reducing transfusion requirements in cases ofmassive hemorrhage, but mortality unrelated to bleedingis high in patients experiencing this complication. Furtherstudy is needed to better assess the utility, dosing, and idealtiming in the use of this drug (AU)

Efficacy and safety of intravenous iron therapy as an alternative/adjunct to allogeneic blood transfusion.

Anaemia is a common condition among patients admitted to hospital medicosurgical departments, as well as in critically ill patients. Anaemia is more frequently due to absolute iron deficiency (e.g. chronic blood loss) or functional iron deficiency (e.g. chronic inflammatory states), with other causes being less frequent. In addition, preoperative anaemia is one of the major predictive factors for perioperative blood transfusion. In surgical patients, postoperative anaemia is mainly caused by perioperative blood loss, and it might be aggravated by inflammation-induced inhibition of erythropoietin and functional iron deficiency (a condition that cannot be corrected by the administration of oral iron). All these mechanisms may be involved in the anaemia of the critically ill. Intravenous iron administration seems to be safe, as very few severe side-effects were observed, and may result in hastened recovery from anaemia and lower transfusion requirements. However, it is noteworthy that many of the recommendations given for intravenous iron treatment are not supported by a high level of evidence and this must be borne in mind when making decisions regarding its application to a particular patient. Nonetheless, this also indicates the need for further large, randomized controlled trials on the safety and efficacy of intravenous iron for the treatment of anaemia in different clinical settings.

Posibles implicaciones del déficit de vitamina B12 en el paciente quirúrgico / No disponible

No disponible

[Preoperative use of intravenous iron: a new transfusional therapy]. / Uso preoperatorio de hierro endovenoso, una nueva terapéutica en medicina transfusional.

INTRODUCTION AND OBJECTIVE: Improving preoperative hemoglobin levels reduces transfusion requirements. The availability in Spain of iron sucrose formulas with good safety profiles has added a new therapeutic option for treating anemia. The aim of this study was to demonstrate the usefulness of preoperative intravenous infusion of iron for improving hemoglobin level before elective major orthopedic surgery. PATIENTS AND METHODS: From the beginning of 2003 until July 2004, 27 consecutive patients scheduled to undergo major orthopedic surgery were given preoperative intravenous iron infusions because of intolerance to oral iron administration, poor intestinal absorption, chronic inflammatory anemia, or functional iron deficit. Twenty patients received preoperative intravenous epoetin alfa and iron and 7 received only intravenous iron because epoetin alfa therapy was ruled out due to cardiovascular or thromboembolic disease or because they had pure iron deficiency. Variables studied were age, sex, weight, type of surgery, iron dose, duration of treatment, reason for treatment, blood parameters, hemoglobin levels, and use of transfusions. RESULTS: The preoperative increase in hemoglobin was 1.7 g dL(-1) (range, 10.8-12.5) for patients who received only intravenous iron therapy and half of them were transfused, although inappropriately in 1 case. The increase in the intravenous epoetin alfa plus iron group was 1.7 g dL(-1) (range, 10.9-12.6) and only 25% were transfused. CONCLUSIONS: Intravenous iron therapy improved the preoperative hemoglobin levels in anemic patients scheduled for major orthopedic surgery. This is a new intravenous treatment approach to evaluate.