Hemopure (hemoglobin glutamer-250 [bovine]; HBOC-201) is a hemoglobin (Hb)-based oxygen carrier registered with the Medicines Control Council of South Africa. It is indicated for the treatment of adult patients who are acutely anemic, for the purpose of maintaining tissue oxygen delivery thus eliminating, delaying, or reducing the need for allogeneic red blood cells (RBCs). Hemopure is a volume expander, and circulatory volume must be carefully monitored for signs of fluid overload. Hemopure is not as effective as RBCs for restoring Hb content and concentration, but in cases of severe anemia where allogeneic blood is not an option or is unavailable, it may offer an immediate alternative for improving oxygen transport. This document provides clinical recommendations on the safe and effective use of Hemopure based on the postmarketing experience in South Africa as well as a better understanding of Hemopure properties reflected in recent publications.

As allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to TSA (AABT) have emerged, but there is a huge variability with respect to their indications and appropriate use. This variability results from the interplay of a number of factors, which include physicians specialty, knowledge and preferences, degree of anaemia, transfusion policy, and AABT availability. Since the ABBT are not harmless and may not meet costeffectiveness criteria, such avariability is unacceptable. The Spanish Societies of Anaesthesiology (SEDAR), Haematology and Haemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Haemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these six Societies have conducted a systematic review of the medical literature and developed the «2013. Seville Document of Consensus on Alternatives to Allogeneic Blood Transfusion», which only considers those AABT aimed to decrease the transfusion of packed red cells. The AABTs are defined as any pharmacological and non-pharmacological measure aimed to decrease the transfusion of of red blood cell concentrates, while preserving the patient safety. For each AABT, the main question is formulated, positively or negatively, as: «Does or does not this particular AABT reduce the transfusion rate?» All the recommendations on the use of AABTs were formulated according to the GRADE (Grades of Recommendation Assessment, Development and Evaluation) methodology.
La transfusión de sangre alogénica (TSA) no es inocua, y como consecuencia han surgido múltiples alternativas a la TSA (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, grado de anemia, política transfusional, disponibilidad de las ATSA y criterio personal, las ATSA 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 seis sociedades han 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 GRADE (Grades of Recommendation Assessment, Development and Evaluation).

BACKGROUND: Evidence-based recommendations can be made with respect to many aspects of the acute management of the bleeding trauma patient, which when implemented may lead to improved patient outcomes.
METHODS: The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing guidelines for the management of bleeding following severe injury. Recommendations were formulated using a nominal group process and the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) hierarchy of evidence and were based on a systematic review of published literature.
RESULTS: Key recommendations include the following: The time elapsed between injury and operation should be minimised for patients in need of urgent surgical bleeding control, and patients presenting with haemorrhagic shock and an identified source of bleeding should undergo immediate surgical bleeding control unless initial resuscitation measures are successful. A damage control surgical approach is essential in the severely injured patient. Pelvic ring disruptions should be closed and stabilised, followed by appropriate angiographic embolisation or surgical bleeding control, including packing. Patients presenting with haemorrhagic shock and an unidentified source of bleeding should undergo immediate further assessment as appropriate using focused sonography, computed tomography, serum lactate, and/or base deficit measurements. This guideline also reviews appropriate physiological targets and suggested use and dosing of blood products, pharmacological agents, and coagulation factor replacement in the bleeding trauma patient.
CONCLUSIONS: A multidisciplinary approach to the management of the bleeding trauma patient will help create circumstances in which optimal care can be provided. By their very nature, these guidelines reflect the current state-of-the-art and will need to be updated and revised as important new evidence becomes available.

The Consensus Document on Alternatives to Allogenic Blood Transfusion (AABT) has been drawn up by a panel of experts from 5 scientific societies. The Spanish Societies of Anesthesiology (SEDAR), Critical Care Medicine and Coronary Units (SEMICYUC), Hematology and Hemotherapy (AEHH), Blood Transfusion (SETS) and Thrombosis and Hemostasis (SETH) have sponsored and participated in this Consensus Document. Alternatives to blood transfusion have been divided into pharmacological and non-pharmacological, with 4 modules and 12 topics. The main objective variable was the reduction of allogenic blood transfusions and/or the number of transfused patients. The extent to which this objective was achieved by each AABT was evaluated using the Delphi method, which classifies the grade of recommendation from A (supported by controlled studies) to E (non-controlled studies and expert opinion). The experts concluded that most of the indications for AABT were based on middle or low grades of recommendation, \"C\", \"D\", or \"E\", thus indicating the need for further controlled studies.

The Blood Transfusion Law has been newly established in Japan since 2003. Under the new law, physicians and co-medical staff have to work hard to establish safer blood transfusion systems and more appropriate transfusion of blood components for the patients in their hospitals. Guide lines for transfusion of blood components made by the Ministry of Health, Welfare, and Labor in Japan are useful tools to accomplish the aims shown above. When they would transfuse blood components appropriately to the patients according to the guidelines, more fresh frozen plasma could be available for the raw materials to produce albumin components and immunoglobulin components those are now partially imported from the foreign countries. Eventually, blood components consumed in Japan for transfusion will be supplied by 100% inland donors blood.

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New Food and Drug Administration guidelines allow research to be done under an \"exception to informed consent.\" These guidelines mandate advance public disclosure (PD) but provide no specifics for how to accomplish this task. This report outlines the history of informed consent in emergency care situations, highlights the Food and Drug Administration regulations for an exception to informed consent, and describes a stepwise approach with specific details of a PD program for a study using a blood substitute. This descriptive report can serve as a guideline for subsequent emergency care investigators in the development of a strategic plan for PD.

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