REDS-IV-P DOMESTIC HUBS PHASE 2

REDS-IV-P 国内枢纽第二阶段

• 批准号: 10469121
• 负责人: Brian Custer
• 金额: $ 141.53万
• 依托单位: VITALANT
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10469121
• 关键词: Adult; Area; Attention; Blood; Blood Transfusion; Blood donor; Brazil; Caring; Charge; Child; Childhood; Community Hospitals; Contracts; Data; Data Analyses; Data Collection; Data Coordinating Center; Databases; Development; Effectiveness; Epidemiology; Evaluation Studies; Goals; Hospitals; Infrastructure; Laboratories; Laboratory Study; Link; Manuals; Mentors; National Heart, Lung, and Blood Institute; Phase; Pilot Projects; Policies; Procedures; Protocols documentation; Publications; Research; Research Personnel; Resources; Safety; Services; Shipping; Site; Transfusion; United States; Vascular blood supply; Veins; base; epidemiology study; improved; medical specialties; meetings; neonate; operation; programs; protocol development; research study; symposium; transfusion medicine

The goal 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. 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. The domestic program consists of 4 research sites within the United States which are referred to as Domestic Hubs and are supported by a data coordinating center (DCC) and a central laboratory. Each 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). This contract is for the base period of phase 2 for one of the domestic hubs.

REDS-IV-P项目的目的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，不仅关注成人，还关注需要输血的新生儿和儿童。REDS-IV-P是美国和巴西的一项为期7年的多中心计划，负责在献血者和输血接受者中进行流行病学和实验室研究。REDS-IV-P分为3个阶段：1）第1阶段（第1-2年）包括制定REDS-IV-P研究协议，制定和试点一个链接的捐助-组成部分-受援国（静脉到静脉）数据库，进行1期研究，并使用现有输血数据库进行数据分析; 2）第二阶段（3-5年）包括进行第2阶段研究方案，汇编静脉数据库和数据分析，并通过演示和出版物传播研究结果; 3）第3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。国内项目由美国境内的4个研究中心组成，这些研究中心被称为国内枢纽，并由数据协调中心（DCC）和中心实验室提供支持。 每个中心都有一个血液中心和输血服务，为参与REDS-IV-P的几家专科护理和社区医院（共22家医院）提供服务。该合同适用于其中一个国内枢纽的第二阶段基期。