REDS-IV-P DATA COORDINATING CENTER PHASE 2

REDS-IV-P 数据协调中心第 2 阶段

• 批准号: 10469117
• 负责人: SUNITHA MATHEW
• 金额: $ 706.3万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10469117
• 关键词: Adult; Attention; Biometry; Blood; Blood Transfusion; Blood donor; Brazil; Caring; Charge; Child; Childhood; Collaborations; Community Hospitals; Contractor; Contracts; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Set; Databases; Development; Documentation; Effectiveness; Ensure; Epidemiology; Ethical Review; Evaluation Studies; Funding; Government Agencies; Group Meetings; Hospitals; Human; Institutional Review Boards; International; Laboratory Study; Link; Logistics; Manuals; National Heart, Lung, and Blood Institute; Phase; Preparation; Privatization; Procedures; Protocols documentation; Publications; Records; Reporting; Research; Research Activity; Research Personnel; Resources; Retrieval; Safety; Services; Site Visit; Statistical Data Interpretation; System; Training; Transfusion; Travel; Vascular blood supply; Veins; central database; data management; epidemiology study; expiration; human subject protection; improved; medical specialties; member; neonate; operation; programs; protocol development; research study; technical report; web site; working group

The objectives of the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) program is to evaluate and improve the safety and availability of the blood supply, as well as the safety and effectiveness of transfusion therapies, with attention to not only adults, but also neonates and children who need transfusion. REDS-IV-P is a seven-year multicenter program, in the US and in Brazil, charged with conducting epidemiologic and laboratory studies in blood donors and transfusion recipients. The REDS-IV-P Program is comprised of 4 domestic hubs and a Brazil transfusion program involving investigators from the U.S. and from the Brazilian blood centers. Each domestic hub has a blood center and transfusion services that serve several specialty care and community hospitals participating in REDS-IV-P (total of 22 hospitals). The domestic Hubs and the Brazil international programs are each supported by a Data Coordinating Center (DCC) and Center for Transfusion Laboratory Studies (CTLS). REDS-IV-P is divided into 3 phases: 1) Phase 1 (Years 1-2) includes development of the REDS-IV-P research protocols, the development and pilot of a linked donation-component-recipient (vein to vein) database, the conduct of phase 1 research studies, and the conduct of data analyses using existing transfusion databases; 2) Phase 2 (Years 3-5) includes the conduct of phase 2 research protocols, compilation of the vein to vein database and data analyses, and dissemination of findings through presentations and publications; and 3) Phase 3 (Years 6-7) includes dissemination of findings through presentations and publications, closure of databases, and provision of all deliverables to NHLBI. This contract is for the DCC phase 2 activities.

受体流行病学和献血者评价研究iv -儿科（red - iv - p）项目的目标是评估和提高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，不仅关注成年人，还关注需要输血的新生儿和儿童。red - iv - p是一个在美国和巴西开展的为期7年的多中心项目，负责对献血者和输血接受者进行流行病学和实验室研究。red - iv - p项目由4个国内中心和一个巴西输血项目组成，涉及来自美国和巴西血液中心的研究人员。每个国内中心都有一个血液中心和输血服务，为参与red - iv - p的几家专科护理医院和社区医院（共有22家医院）提供服务。国内中心和巴西国际项目分别由数据协调中心（DCC）和输血实验室研究中心（CTLS）提供支持。red - iv - p分为3个阶段：1)第一阶段（1-2年）包括制定red - iv - p研究方案，开发和试点关联捐赠成分-受体（静脉对静脉）数据库，开展第一阶段研究，并使用现有输血数据库进行数据分析；2)第二阶段（3-5年）包括第二阶段研究方案的实施，静脉到静脉数据库的编制和数据分析，以及通过演讲和出版物传播研究结果；3)第三阶段（6-7年级）包括通过演讲和出版物传播研究结果，关闭数据库，并向NHLBI提供所有可交付成果。该合同是DCC第二阶段活动的合同。