Research Study to Assess the Risk of Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease

评估典型克雅氏病血源性传播风险的研究

• 批准号: 9130020
• 负责人: Whitney Randolph Steele
• 金额: $ 7.6万
• 依托单位: AMERICAN NATIONAL RED CROSS
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9130020
• 关键词: Research; Study; Assess; Risk; Blood

DESCRIPTION (provided by applicant): Creutzfeldt-Jakob disease (CJD) is a rare fatal neurodegenerative disorder caused by abnormal prion agents. Transmissibility of the classic forms of CJD by blood transfusion is currently unknown. The proposed project will continue the only active, nationwide look-back study on recipients of blood products from donors subsequently diagnosed with classic CJD. This study began in 1995, and has been working for the past 20 years on the key objective of carefully and systematically assessing the risk of blood borne transmission of this disease in the United States. The major components of the study include collaboration with multiple sources to identify blood donors diagnosed with classic CJD in the United States; working with blood centers to trace the blood components from donors diagnosed with classic CJD to final disposition; collecting vital status and cause of death information (if applicable) on the recipients of blood components; utilizing the data from the study to continually monitor and assess the risk of blood-borne transmission of CJD; and disseminating results of the study to relevant stakeholders. To date, the study has enrolled 54 blood donors who died of classic CJD and 666 recipients of their blood. Through 2013, 125 of these recipients were presumed to be still alive, 520 were deceased and 21 were lost to follow-up. Post transfusion, these three groups had survived a total of 2719.5 person-years. A total of 187 recipients survived five years or longer post transfusion and 86 of them had received blood donated 60 or fewer months before the onset of CJD in the donor. No recipients with CJD have been identified. The current results of this large, ongoing look-back study show no evidence of transfusion transmission of CJD. They reinforce the conclusion that the risk, if any, of transfusion transmission of prion disease by classic CJD donors is significantly lower than the comparable risk of such transmission by vCJD donors.

描述（由申请人提供）：克雅氏病（CJD）是一种罕见的致命性神经退行性疾病，由异常朊病毒因子引起。经典形式的克雅氏病通过输血的传播性目前尚不清楚。拟议的项目将继续进行唯一一项积极的全国性回顾研究，研究对象是后来被诊断为典型克雅氏病的献血者的血液制品接受者。这项研究始于1995年，过去20年来一直致力于仔细、系统地评估美国这种疾病血源性传播风险的关键目标。该研究的主要组成部分包括与多个来源合作，以确定美国诊断为典型CJD的献血者;与血液中心合作，追踪诊断为典型CJD的献血者的血液成分，直至最终处置;收集生命状态和死亡原因信息。（如适用）对血液成分接受者的影响;利用研究数据持续监测和评估克雅二氏病经血液传播的风险;并向相关利益攸关方传播研究结果。 到目前为止，该研究已经招募了54名死于典型CJD的献血者和666名接受血液的人。截至2013年，这些接受者中有125人被认为仍然活着，520人死亡，21人失访。输血后，这三组共存活2719.5人年。共有187名受血者在输血后存活了5年或更长时间，其中86人在献血者发病前60个月或更短时间内接受了献血。没有发现患有克雅二氏症的受助人。 这项大型的、正在进行的回顾性研究的目前结果显示，没有证据表明输血传播克雅氏病。他们加强了这样的结论，即经典CJD供体输血传播朊病毒疾病的风险（如果有的话）显著低于vCJD供体的类似风险。