Transfusion Infections Pedi Prospective Study (TRIPPS)

输血感染足部前瞻性研究 (TRIPPS)

• 批准号: 6320088
• 负责人: NAOMI L LUBAN
• 金额: $ 32.48万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-10 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6320088
• 关键词: age difference; blood bank /supply contamination; blood banks; blood donor; blood transfusion; clinical research; communicable disease transmission; disease /disorder proneness /risk; emerging infectious disease; human subject; mass screening; pediatrics; virus diseases

DESCRIPTION (Verbatim from the application): A prospective study of pediatric transfusion recipients will be conducted to determine the residual risk of transmitting known infectious agents such as hepatitis viruses, HIV and HTLV, for which there are current donor screening assays, and the potential risk of known agents that are not routinely screened during blood donation, but might, nonetheless, infect blood recipients with diseases such as cytomegalovirus, parvovirus B-19, human herpes virus-8 (HHV-8) and newly proposed hepatitis viruses, TTV and SEN-V. An additional primary goal of the study will be to establish a repository of linked donor and recipient samples so that if a new infectious agent emerges in the future, testing of the repository will rapidly establish whether or not that agent presents a threat to the blood supply. To insure larger numbers of samples and greater statistical power, samples from this study will be merged into a large repository to be generated in the NHLBI-sponsored RADAR (REDS Allogeneic Donor and Recipient) study. The current study will be the only pediatric arm of the RADAR multi-center study. Further, the current pediatric study will be undertaken collaboratively with a similarly designed study in adults being conducted at the NIH Clinical Center. In both studies recipients will be enrolled prior to transfusion and then followed for at least 6 months post-transfusion. Blood samples will be obtained before and at 2, 4, 8, 12, 16 and 24 weeks after transfusion. Molecular and serologic testing will be routinely performed for the agents cited above with particular emphasis on molecular assays for HRV, HCV. HIV, SEN-V, CMV, parvovirus B-i 9 and HHV-8. Aliquots will be retained in frozen storage. In addition, pre and post-transfusion and donor whole blood samples will be frozen to allow for recovery of recipient DNA and identification of microchimerism. Such microchimerism may result in transfusion-associated graft versus host disease and immunosuppression and have long term consequences for the development of immune mediated diseases in the recipient. In summary, the primary pediatric study and the proposed collaborations will allow for determinations of the transfusion risk of a variety of blood-screened and unscreened infectious agents, and will allow for comparisons of transfusion risk between pediatric and adult patients, as well as comparisons of viral persistence and clinical outcome according to age. In addition, by contributing pre and post-transfusion samples from blood recipients and their linked donor samples, this study will help establish a large serum and cell repository that will allow for the future determination of whether virtually any infectious agent is transfusion-transmitted and a potential risk to blood recipients.

描述（逐字化申请书）：小儿的前瞻性研究 将进行输血接收者，以确定 传播已知的传染剂，例如肝炎病毒，HIV和HTLV， 为此，目前有捐助者筛选分析，以及 在献血期间不常规筛选的已知药物，但可能会 尽管如此，感染血液接受者的疾病，例如巨细胞病毒， 细小病毒B-19，人疱疹病毒8（HHV-8）和新提出的肝炎 病毒，TTV和SEN-V。研究的另一个主要目标是 建立一个链接的捐赠者和收件人样本的存储库，以便如果新的 传染剂将来出现，对存储库的测试将迅速 确定该代理是否对血液供应构成威胁。到 确保大量样本和更大的统计能力，来自 这项研究将合并为大型存储库，以在 NHLBI赞助的雷达（红色同种异体供体和受体）研究。电流 研究将是雷达多中心研究的唯一小儿组。更远， 当前的小儿研究将与类似 在NIH临床中心进行的成年人设计研究。在这两个中 研究接受者将在输血之前注册，然后遵循 传输后至少6个月。将在之前获得血液样本 输血后的2、4、8、12、16和24周。分子和血清学 测试通常会针对上述特定的代理进行 强调HRV的分子测定，HCV。 HIV，SEN-V，CMV，细小病毒B-I 9 和HHV-8。等分试样将保留在冷冻存储中。此外，前和 转移后和供体全血样样本将被冷冻以允许 恢复受体DNA和微chimerismism的鉴定。这样的 微chimer起来可能导致输血相关的移植物与宿主疾病 和免疫抑制，并对发展产生长期后果 受体中免疫介导的疾病。 总而言之，主要的儿科研究和拟议的合作将 允许确定各种血液筛选的输血风险 和未经筛选的传染剂，并可以进行输血的比较 小儿和成人患者之间的风险以及病毒的比较 根据年龄的持久性和临床结果。另外，通过贡献 来自血液接受者及其链接供体的转移前后样品 样本，这项研究将有助于建立一个大的血清和细胞存储库， 将允许将来确定几乎任何传染性 代理是输血的，对血液接受者有潜在的风险。