Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait

镰状细胞病和镰状细胞性状中的静脉血栓形成生物标志物

• 批准号: 10492973
• 负责人: Arun Shet
• 金额: $ 25.63万
• 依托单位: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10492973
• 关键词: Acute; African; Biological Assay; Biological Markers; Blood Vessels; Blood specimen; Cells; Coagulation Process; Cohort Studies; Collaborations; Complex; Deposition; Development; Endothelial Cells; Enrollment; Extramural Activities; Factor X; Factor Xa; Fibrin; Generations; Individual; Laboratories; Medicine; Patients; Plasma; Protocols documentation; Recording of previous events; Recurrence; Reporting; Research Personnel; Research Subjects; Sampling; Sickle Cell Anemia; Sickle Cell Trait; Site; System; Telephone; Testing; Thrombelastography; Thrombin; Thromboplastin; Thrombosis; United States National Institutes of Health; Venous; Venous Thrombosis; Vesicle; cohort; extracellular vesicles; factor IXa-factor VIIIa; follow-up; monocyte; platelet function; prospective; recruit; sickle cell crisis; telehealth; thrombotic; venous thromboembolism; vesicular release

Since recruitment began in August 2020, protocol 20H0068 has recruited subjects with Sickle Cell Disease (SCD) with and without a recent history of venous thromboembolism. In addition, the protocol recruits individuals with Sickle Cell Trait (SCT) and those individuals identifying themselves as healthy and of African ancestry. The two cohorts of subjects (SCD and SCT) will be followed prospectively for a period of two years. One cohort consisting of SCD patients will be followed up on site whereas the other cohort of SCT and healthy individuals will be followed up via Telehealth. Standard operating protocols for processing of blood samples have been tested in the laboratory and assays for platelet function have been developed. In collaboration with the department of laboratory medicine, thromboelastography is performed on all subjects recruited to the protocol. Assays to study plasma hyper coagulability are under development and samples that are being collected are stored for batch analysis under standard conditions. Assays to assess cell derived extracellular vesicles and tissue factor bearing vesicles are being performed. In collaboration with extramural investigators, the possibility that plasma contains cell derived vesicles from subendothelial compartments is under exploration. As of the date of this report, a total of 60 research subjects in all four of the study cohorts out of a possible 200 have been enrolled. An additional 8 subjects have been brought into the NIH CC for study of biomarker variability during acute vast-occlusive crisis. Subjects in the SCD cohort receive 3 monthly phone follow up. Subjects in the SCT cohort receive annual telephone follow up.

自2020年8月开始招募以来，PROGET 20H0068招募了有和没有近期静脉血栓栓塞史的镰状细胞病(SCD)受试者。此外，该方案还招募具有镰刀细胞特征(SCT)的个人以及那些认为自己健康且具有非洲血统的个人。 这两组受试者(SCD和SCT)将被前瞻性地跟踪两年。一组由SCD患者组成的队列将在现场进行随访，而另一组SCT和健康人将通过TeleHealth进行随访。已经在实验室测试了血液样本处理的标准操作规程，并开发了血小板功能检测方法。与实验室医学部合作，对招募到该方案的所有受试者进行血栓弹性成像。 研究血浆高凝状态的分析方法正在开发中，正在收集的样本被储存起来，以便在标准条件下进行批量分析。正在进行评估细胞来源的细胞外小泡和含组织因子的小泡的分析。在与外部研究人员的合作下，血浆中含有来自内皮下室的细胞来源的囊泡的可能性正在探索中。 截至本报告之日，在可能的200个研究队列中，所有四个研究队列中总共有60个研究对象已经登记。另有8名受试者被带入美国国立卫生研究院CC，用于研究急性巨大闭塞危象期间的生物标记物变异性。SCD队列中的受试者每月接受3次电话随访。SCT队列中的受试者每年都会接受电话随访。