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: 10262685
• 负责人: Arun Shet
• 金额: $ 25.68万
• 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/10262685
• 关键词: Acute; Biological Assay; Biological Markers; Blood Vessels; Blood specimen; COVID-19 pandemic; Cells; Coagulation Process; Collaborations; Complex; Deposition; Endothelial Cells; Enrollment; Ensure; Factor X; Factor Xa; Fibrin; Generations; Individual; Institutional Review Boards; Laboratories; Medicine; Minor; Modification; Patients; Plasma; Protocols documentation; Recurrence; Sickle Cell Anemia; Sickle Cell Trait; Site; System; Testing; Thrombelastography; Thrombin; Thromboplastin; Thrombosis; Venous; Venous Thrombosis; cohort; extracellular vesicles; factor IXa-factor VIIIa; follow-up; monocyte; platelet function; prospective; recruit; sickling; telehealth; vesicular release

The protocol was approved by the IRB in March 2020 but could not begin recruitment due to the COVID-19 pandemic. Since then it has been amended and recruitment has begun in August 2020. Since March, minor modifications to ensure that recruitment and subject accrual are in conjunction with institutional norms have been implemented and the protocol has been amended accordingly. 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 will be performed on all subjects recruited to the protocol. The protocol will enroll two cohorts of subjects, both of which 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.

该方案于2020年3月获得IRB批准，但由于COVID-19大流行而无法开始招募。自那时以来，它已被修改，并于2020年8月开始招募。自3月以来，为确保招募和受试者累积符合机构规范，已进行了微小修改，并对方案进行了相应修订。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。将与实验室医学部门合作，对方案招募的所有受试者进行血栓弹性描记术。方案将入组两个队列的受试者，均将前瞻性随访2年。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。