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: 10706189
• 负责人: Arun Shet
• 金额: $ 20.29万
• 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/10706189
• 关键词: Acute; African ancestry; 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 57 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 phone follow up every 3 months. Subjects in the SCT cohort receive annual telephone follow up.

自2020年8月开始招募以来，方案20H0068招募了有和无近期静脉血栓栓塞病史的镰状细胞病（SCD）受试者。此外，该方案招募具有镰状细胞特征（SCT）的个人和那些认为自己是健康的非洲血统的个人。 将对两个受试者队列（SCD和SCT）进行为期两年的前瞻性随访。一个由SCD患者组成的队列将在研究中心进行随访，而另一个SCT和健康个体队列将通过远程医疗进行随访。已在实验室测试了处理血样的标准操作规程，并开发了血小板功能测定法。与实验室医学部合作，对方案招募的所有受试者进行血栓弹性描记术。 研究血浆高凝性的试验正在开发中，收集的样品在标准条件下储存用于批分析。正在进行评估细胞衍生的细胞外囊泡和组织因子承载囊泡的测定。与校外研究人员合作，血浆中含有来自内皮下室的细胞衍生囊泡的可能性正在探索中。 截至本报告日期，所有4个研究队列中总共入组了57例研究受试者（共200例）。另外8例受试者已纳入NIH CC，用于研究急性大动脉闭塞危象期间的生物标志物变异性。SCD队列中的受试者每3个月接受一次电话随访。SCT队列中的受试者每年接受一次电话随访。