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.

受者流行病学和供者评估研究 IV-儿科 (REDS-IV-P) 计划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，并关注不仅是成人，还有需要输血的新生儿和儿童。 REDS-IV-P 是一个为期七年的多中心项目，在美国和巴西开展，负责对献血者和输血接受者进行流行病学和实验室研究。 REDS-IV-P 计划由 4 个国内中心和巴西输血计划组成，该计划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 REDS-IV-P 的多家专科护理和社区医院（总共 22 家医院）提供服务。国内中心和巴西国际项目均得到数据协调中心 (DCC) 和输血实验室研究中心 (CTLS) 的支持。 REDS-IV-P 分为 3 个阶段： 1) 第 1 阶段（第 1-2 年）包括开发 REDS-IV-P 研究方案、开发和试点关联的捐赠-组件-接受者（静脉到静脉）数据库、进行第一阶段研究以及使用现有输血数据库进行数据分析； 2) 第 2 阶段（第 3-5 年）包括实施第 2 阶段研究方案、编制静脉到静脉数据库和数据分析，以及通过演示和出版物传播研究结果； 3) 第 3 阶段（第 6-7 年）包括通过演示和出版物传播调查结果、关闭数据库以及向 NHLBI 提供所有可交付成果。 该合同适用于 DCC 第 2 阶段活动。