IGF::OT::IGF Recipient Epidemiology and Donor Evaluation Study III (REDS-III) - International Sites - Phase 3

REDS-III计划的目标是通过涉及基础研究、转化研究和临床研究的全面、多目标战略，确保安全有效的血库和输血医学实践，以提高输血的好处，同时降低其风险。通过进行流行病学、调查和实验室研究来提高美国和国际上血液成分的安全性和可用性是REDS计划的基石。输血疗法是美国最常用的，也是可以说是最不为人所知的医疗程序之一，每年影响大约500万接受治疗的人。这项研究计划不仅对美国的公共卫生至关重要，而且对正在与艾滋病毒疫情作斗争的国家也是如此，在这些国家，血液安全和可获得性是主要问题。REDS-III项目由一个数据协调中心(DCC)、一个中心实验室、四个国内枢纽和三个国际合作项目组成，其中包括美国调查人员和国际血液中心的调查人员。REDS-III计划将针对以下血库和输血医学领域：献血者定向战略；血库；成人患者的输血实践；以及教育和培训。该国际计划的目标是解决科学问题，以改善受艾滋病毒/艾滋病疫情影响的特定低收入或中等收入国家的血液供应的安全性和充分性。REDS-III国际站点应主要对献血者进行流行病学、实验室和调查研究，主要研究重点是减少和预防通过输血传播艾滋病毒/艾滋病和其他已知和新出现的传染病。也可以对输血接受者进行研究。 国际方案研究的主要目标是：1)评估和监测HIV-1、HIV-2和其他现有的以及新发现的对血液安全构成威胁的感染性病原体的流行和发病率；2)评估通过输血传播感染的风险；3)评估现有的和新的献血者筛查方法对血液安全和可获得性的影响；4)评估献血者的特征和行为，包括感染艾滋病毒和其他血液传播病原体的风险因素；以及5)评估献血过程，以改善血液供应的安全性和充分性。一些研究还可能涉及输血接受者的安全问题，例如评估非传染性输血风险(例如，同种免疫)和减少其发生的方法。

The objectives of the REDS-III program are to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the most commonly employed, and, arguably, one of the least understood medical procedures in the U.S. affecting about five million recipients annually. This research program is not only critical to public health in the U.S. but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. The REDS-III program is comprised of one Data Coordinating Center (DCC), one Central Laboratory, four domestic hubs, and three international collaborative programs involving U.S. investigators and investigators at international blood centers. The REDS-III program will target the following blood banking and transfusion medicine areas: donor targeted strategies; blood banking; transfusion practices in adult patients; and education and training. The goal of the International program is to address scientific questions to improve the safety and adequacy of the blood supply in selected low or middle income countries affected by the HIV/AIDS epidemic. The REDS-III international sites shall conduct epidemiologic, laboratory, and survey research primarily on blood donors with a major research focus on reducing and preventing the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion. Studies in transfusion recipients may also be conducted. The major objectives of the research in the international program are: 1) assess and monitor the prevalence and incidence of HIV-1, HIV-2 and other existing as well as newly discovered infectious agents that pose a threat to blood safety; 2) assess risks of transfusion-transmitted infections; 3) assess the impact of existing and new blood donor screening methodologies on blood safety and availability; 4) evaluate characteristics and behaviors of blood donors including risk factors for acquiring HIV and other blood-borne agents; and 5) evaluate the donation process for ways to improve the safety and adequacy of the blood supply. Some studies may also address transfusion recipient safety concerns such as evaluating non-infectious transfusion risks (e.g., alloimmunization) and ways to reduce their occurrence.