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临床试验/NCT07019038
NCT07019038招募中不适用

National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia

Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 9,999 人开始时间: 2001年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
9,999
试验地点
1
主要终点
Hematologic response

研究概览

简要总结

Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology.

The objectives of this study are to investigate the incidence and risk factors of autoimmune hemolytic anemia (AIHA) and to analyze the treatment effectiveness, patient prognosis and healthcare costs in China.

  1. Analyze the demographic and clinical characteristics of patients with AIHA, including sex, age, disease severity, and other relevant factors.
  2. Examine disease features of AIHA patients, such as biochemical and hematological indicators
  3. Assess treatment patterns and real-world effectiveness in AIHA patients.
  4. Evaluate clinical outcomes, including hematologic response, relapse, and mortality
  5. Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects diagnosed with AIHA.
  • Hemoglobin<100g/L
  • Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2001.

排除标准

  • Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
  • Subject with alcohol or drug dependence may reduce their compliance with the study.
  • Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.

结局指标

主要结局

Hematologic response

时间窗: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.

Hematologic response contains improvements in hemoglobin.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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