Research Study to Assess the Risk of Blood Borne Transmission of Creutzfeldt-Jako
评估克雅氏菌血源性传播风险的研究
基本信息
- 批准号:7930636
- 负责人:
- 金额:$ 9.39万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2009
- 资助国家:美国
- 起止时间:2009-09-01 至 2014-08-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
DESCRIPTION (provided by applicant): Creutzfeldt Jakob disease (CJD) is a fatal neurodegenerative disorder caused by prion agents. In 1996, another human prion disease, variant CJD, emerged in the United Kingdom. The purpose of this application is to continue an active, nationwide study begun in 1995 of recipients of blood products from blood donors subsequently diagnosed with classic CJD to assess the risk of blood borne transmission of this disease in the United States. The study will be conducted as follows: 1) maintain and increase collaborative relationships with US blood banks to identify blood donors diagnosed with CJD in the United States and gather available, relevant, medical and demographic information on such donors; 2) trace CJD donor blood components to final disposition; 3) maintain and enhance collaborative relations with final disposition sites and collect vital statistics information from pre-existing records about recipients of CJD blood components; 4) maintain study information about the recipients of the blood components from CJD donors who were previously identified in this study and continue to monitor these recipients' vital status, including the causes of death should they die; 5) continue a plan that will (a) search national, state, and local organizations databases to match vital statistics and causes of death for the component recipients, including utilizing non-National Death Index databases to confirm the vital status of the component recipients and (b) assess the risk of blood-borne transmission of CJD; 6) publish and disseminate results of the study. Data that will be systematically collected from this study will help determine whether classic CJD is being transmitted by blood and blood components in the United States.
PUBLIC HEALTH RELEVANCE: This study collects recipient outcome data to assess the potential risk of transmission of Creutzfeldt-Jakob disease (CJD) by blood components from donors who subsequently developed CJD. There are two phases to this study. A retrospective phase which includes identifying the CJD infected blood donors and the recipients of those blood units and a prospective phase that tracks the recipients of blood donated by CJD donors. During the retrospective phase we receive reports from blood centers, family members and the Centers for Disease Control and Prevention (CDC). Once we receive the report we notify the blood center (if previously not notified), the hospitals and/or transfusion centers identify the recipients and report the survival status and if deceased the date and cause of death of that recipient. If the recipient is listed as deceased we verify the date and cause of death with the National Death Index (NDI). If the recipient is listed as alive we move onto the prospective phase of the study. This consists of tracking the recipient to see if they are currently alive (as of the last available NDI data set) and if not the date and cause of death. We track the recipients by using the National Death Index plus database and other databases when needed. We match the recipient's information to the information in the database to determine if it is a match. The risk to the human subjects is minimal. For donors who are reported by the CDC and Blood Centers only the donor initials are available. For those individuals whose family members report the case, they receive an information letter and Consent for Participation and Release of Information. Investigation does not proceed unless the consent for participation is signed. Names of the family reported donors are kept in a secure cabinet with very limited personnel access. Only the donor initials are used when imputing the data in the database. The risk is minimal for the recipients. The surviving recipients are not notified of the tracking because to date there has not been a transfusion transmission of classic CJD. Notifying the recipient would cause undue stress and mental anguish. This would be an unnecessary harm to the recipient. All recipient information both death and alive are kept in a secure cabinet with very limited personnel access. Names, Date of Birth and Social Security Number of the recipients are reported in the database and the database can only be accessed by specific co-investigators.
描述(申请人提供):克雅氏病(CJD)是一种由普恩病毒引起的致命性神经退行性疾病。1996年,英国出现了另一种人类Pron病,变种CJD。这项申请的目的是继续1995年开始的一项积极的全国性研究,对后来被诊断为典型CJD的献血者的血液产品的接受者进行研究,以评估这种疾病在美国通过血液传播的风险。这项研究将如下进行:1)保持和加强与美国血库的合作关系,以识别在美国被诊断为CJD的献血者,并收集关于这类献血者的现有的、相关的、医疗和人口信息;2)追踪CJD献血者的血液成分直到最终处置;3)保持和加强与最终处置地点的合作关系,并从先前存在的CJD血液成分接受者的现有记录中收集重要统计信息;4)维护关于先前在本研究中确认的CJD捐献者血液成分接受者的研究信息,并继续监测这些接受者的生命状况,包括他们死亡时的死因;5)继续执行一项计划,该计划将(A)搜索国家、州和地方组织的数据库,以匹配组成部分接受者的生命统计数据和死亡原因,包括利用非国家死亡指数数据库来确认组成部分接受者的生命状况和(B)评估通过血液传播慢性病的风险;6)出版和传播研究结果。从这项研究中系统收集的数据将有助于确定经典的CJD是否在美国通过血液和血液成分传播。
公共卫生相关性:这项研究收集了受者结局数据,以评估后来患上克雅氏病的献血者血液成分传播克雅氏病(CJD)的潜在风险。这项研究分为两个阶段。一个追溯阶段,包括确定感染CJD的献血者和这些血液单位的接受者,以及一个追踪CJD献血者献血接受者的预期阶段。在回顾阶段,我们收到来自血液中心、家庭成员和疾病控制和预防中心(CDC)的报告。一旦我们收到报告,我们就通知血液中心(如果之前没有通知),医院和/或输血中心确定接受者的身份,并报告生存状态,如果已经死亡,还会报告接受者的死亡日期和原因。如果收件人被列为已故者,我们将使用国家死亡指数(NDI)核实死亡日期和原因。如果接受者被列为活着,我们将进入研究的预期阶段。这包括跟踪接受者,以查看他们目前是否还活着(截至最后可用的NDI数据集),如果不是,则跟踪他们的死亡日期和原因。当需要时,我们通过使用国家死亡指数加数据库和其他数据库来跟踪收件人。我们将收件人的信息与数据库中的信息进行匹配,以确定是否匹配。对人类受试者的风险微乎其微。对于CDC和血液中心报告的捐赠者,只有捐赠者的首字母可用。对于其家庭成员举报的个人,他们将收到一封信息信,并同意参与和发布信息。除非签署了参与的同意,否则调查不会继续进行。据报道,捐赠者的家人姓名被保存在一个安全的内阁中,人员准入非常有限。在数据库中输入数据时,只使用捐赠者姓名的首字母。对于接受者来说,风险是最小的。幸存的接受者没有被通知追踪,因为到目前为止还没有典型的CJD的输血传播。通知收件人会造成不必要的压力和精神上的痛苦。这将对接受者造成不必要的伤害。所有收件人的信息,无论是死亡的还是活着的,都保存在一个安全的柜子里,人员访问权限非常有限。数据库中报告了受助人的姓名、出生日期和社会保障号码,只有特定的协查人员才能访问该数据库。
项目成果
期刊论文数量(0)
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{{ truncateString('SHIMIAN ZOU', 18)}}的其他基金
Research Study to Assess the Risk of Blood Borne Transmission of Creutzfeldt-Jako
评估克雅氏菌血源性传播风险的研究
- 批准号:
7808368 - 财政年份:2009
- 资助金额:
$ 9.39万 - 项目类别:
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