(REDS-IV-P) RECIPIENT EPIDEMIOLOGY AND DONOR EVALUATION STUDY IV

REDS计划的目标是评估和改善血液供应的安全性和可用性以及输血治疗的安全性和有效性。该计划还致力于积极应对国家血液供应的潜在新威胁，并为正在进行的输血研究工作提供资源。目前处于第四阶段的REDS流行病学和供体评估研究-IV-儿科（REDS-IV-P）计划主要旨在提高输血的益处，同时降低其风险; REDS计划还将新的重点放在以前研究不足的人群上。 在过去的30年里，REDS一直是美国血液采集和输血安全的首要研究项目。在其第三阶段- REDS-III -该方案侧重于对输血链的所有要素进行研究，从献血者到他们捐献的血液制品，再到通过输血接受产品的成年患者。 REDS-IV-P建立在REDS-III的基础上，额外关注新生儿，儿童和需要输血的孕妇的研究。REDS-IV-P中汇编的数据将使研究人员能够快速解决输血医学中的关键研究问题，并为成人以及儿童和其他未充分研究的患者人群提供血液政策决策。 REDS-IV-P还扩展了在REDS-III中建立的巴西镰状细胞病队列，以评估镰状细胞病的输血实践和相关临床结局。REDS-IV-P巴西输血计划还将继续监测和监测寨卡病毒、基孔肯雅病毒、登革热和其他新出现的威胁血液供应的病毒。 这是具有数据库项目议定书的国内中心，特别关注统计分析计划的制定。 对数据库项目进行统计分析，除非NHLBI COR另有规定。提供必要的统计、流行病学和编程专业知识以及必要的统计软件，以分析遗传/表型和“组学”数据，和/或捐赠者、捐赠者、患者/接受者数据库，并酌情进行复杂的捐赠者-接受者关联分析。

The goal of the REDS program is to evaluate and improve the safety and availability of the blood supply and the safety and effectiveness of transfusion therapies. The program also works to proactively address potential emerging threats to the Nation's blood supply and serves as a resource for ongoing work in transfusion research. Now in its fourth phase, the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) program aims primarily at improving the benefits of transfusion while reducing its risks; the REDS program also has a new focus on previously understudied populations. Over the past 30 years, REDS has been the premier research program in blood collection and transfusion safety in the United States. In its third phase — REDS-III — the program focused on conducting research on all elements of the transfusion chain, from the blood donor to the blood products made from their donation to the adult patients receiving the products through transfusion. REDS-IV-P builds on REDS-III with an additional focus on research with newborns, children, and pregnant women who need transfusions. The data compiled in REDS-IV-P will allow investigators to rapidly address key research questions in transfusion medicine and inform blood policy decisions, for adults as well as for children and other understudied patient populations. REDS-IV-P also extends the Brazilian sickle cell disease cohort that was established in REDS-III to evaluate transfusion practices and associated clinical outcomes in sickle cell disease. The REDS-IV-P Brazilian transfusion program will also continue its monitoring and surveillance efforts for Zika, chikungunya, dengue, and other emerging viral threats to the blood supply. This is the domestic hubs with database project protocols, with particular attention to the development of the statistical analytical plan. Conduct the statistical analysis for the database projects unless otherwise specified by the NHLBI COR. Provide the necessary statistical, epidemiological, and programming expertise as well as the necessary statistical software(s) to conduct analyses of genetic/phenotypic and “omics” data, and/or donors, donations, patient/recipient databases as well as the conduct of complex linked donor-recipient analyses, as appropriate.