National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia

Condition(s) studied

Investigational drug(s) / intervention(s)

A combined retrospective and prospective observational follow-up: The NICHE-AIHA will collect basic information, diagnostic and treatment information, as well as health costs information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Hematologic response — 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.

Trial sites (1)

More Institute of Hematology & Blood Diseases Hospital, China trials in China

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