American Thrombosis and Hemostasis Network ATHNdataset Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200,000
- 试验地点
- 2
- 主要终点
- Comprehensive real-world clinical data registry analysis, research, advocacy, and public health reporting for the blood disorders community
研究概览
简要总结
The Hemophilia Treatment Center (HTC) where you receive care is working with The American Thrombosis and Hemostasis Network (ATHN) to look at the quality of life of people with blood disorders and problems.
Doctors, scientists, policymakers, and other health care providers need a large amount of information from a lot of people to answer scientific, public health, and policy questions about better ways to treat blood disorders. They will use the information from the ATHNdataset to answer these questions.
详细描述
Participants who agree to participate will let their health information be included in the ATHNdataset Registry, and the information will be updated regularly to reflect the participant's current health status. This registry includes collecting, storing and managing health information through a secure database. The following health information will be collected:
- Demographics (e.g., age, gender, income, education/occupation)
- The type of blood disorder you have
- Date you were diagnosed, or symptoms began
- Family history of the disorder
- Testing and assessments
- Physical exams
- Height, weight
- Vital signs, including blood pressure and heart rate
- Laboratory tests (results from blood or urine testing, or biological specimens)
- Genetic test results
- Imaging results (X-rays, CT scans, etc.)
- Pharmacokinetic testing results (how drugs are processed in the body)
- Medications used and any problems with use
- Types of bleeds, pain and clotting problems
- Treatments that stop your bleeding or clotting problems from occurring or getting worse
- Surgeries and/or procedures
- Immunizations (vaccines)
- Devices
- Routine care visits and injuries (trauma)
- Other illnesses and diseases you may have
- Allergies
- Patient-reported outcomes (PROs), questionnaires, and surveys
- Payment details for treatment, including insurance companies and health plans
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any participant evaluated for or the potential to have a blood disorder who has an encounter with an ATHN Affiliate.
- •Participants of any age.
- •Participant is able to provide consent or assent; a Legally Authorized Representative (LAR) may provide consent on a participant's behalf if a participant is unable to provide self-consent
排除标准
- •Any participant unable to provide consent or assent to participate in the ATHNdataset
研究组 & 干预措施
Blood Disorders
The ATHNdataset is a large, robust real-world registry that can be queried to produce curated subsets of data to support clinical care, outcomes analysis, safety monitoring, practice of treatment, advocacy, public health reporting, quality improvement projects, and research initiatives. Initiatives relying on the ATHNdataset may focus on gaining a greater understanding of blood disorders, the complications of these disorders, their social and economic costs, and the effectiveness of treatments.
The population includes all individuals diagnosed with or suspected to have a blood disorder. Participants will contribute data gathered during care encounters with an ATHN Affiliate.
结局指标
主要结局
Comprehensive real-world clinical data registry analysis, research, advocacy, and public health reporting for the blood disorders community
时间窗: 15 years
The ATHNdataset Registry objective is to develop a secure, comprehensive registry of real-world clinical data to support standardized comprehensive health information for persons living with blood disorders and public health reporting for the blood disorders community
次要结局
- Contribute to scientific and public health reporting for the blood disorders community(20 years)