REDS-IV-P CENTER FOR TRANSFUSION LABORATORY STUDIES (CTLS) PHASE 2

REDS-IV-P 输血实验室研究中心 (CTLS) 第二阶段

• 批准号: 10551018
• 负责人: Philip J. Norris
• 金额: $ 459.54万
• 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/10551018
• 关键词: Adult; Attention; Blood; Blood Transfusion; Blood donor; Brazil; Caring; Charge; Child; Childhood; Community Hospitals; Contracts; Data; Data Analyses; Data Coordinating Center; Databases; Development; Effectiveness; Ensure; Epidemiology; Evaluation Studies; Group Meetings; Hospitals; International; Laboratories; Laboratory Study; Lead; Link; Manuals; National Heart, Lung, and Blood Institute; Phase; Procedures; Protocols documentation; Publications; Research; Research Personnel; Safety; Services; Ships; Testing; Transfusion; Vascular blood supply; Veins; Work; base; epidemiology study; improved; medical specialties; neonate; operation; phase 2 study; programs; protocol development; research study; response; transmission process; 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 U.S. investigators and investigators at international 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 supported by one data coordinating center (DCC) and one 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 is the base contract for the CTLS for phase 2.

REDS-IV-P项目的目的是评价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项目由4个国内中心和一个巴西输血项目组成，该项目涉及美国研究人员和国际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中心，为参与REDS-IV-P的几家专科护理和社区医院提供服务（共有22家医院）。 国内中心和巴西国际项目由一个数据协调中心（DCC）和一个输血实验室研究中心（CTLS）提供支持。 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。这是第2阶段CTLS的基础合同。