Clinical trial NCT07019038: National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
Official title: National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AIHA - Warm Autoimmune Hemolytic Anemia
AIHA - Cold Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia Mixed Type
Keywords: Autoimmune Hemolytic Anemia
Treatment patterns
Hematologic response
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 9999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as AIHA.

Diagnostic criteria for AIHA (Autoimmune Hemolytic Anemia):

Hemoglobin level meets the diagnostic threshold for anemia; Decreased serum haptoglobin (\<250 mg/L), elevated total bilirubin (≥17.1 μmol/L, mainly indirect bilirubin), elevated lactate dehydrogenase (LDH), and reticulocyte percentage \>4% or absolute reticulocyte count \>120×10\^9/L; Presence of autoantibodies against red blood cells.

Brief 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hematologic response
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Red Blood Cell Diseases Center and Regenerative Medicine Center
state: Tianjin
Study officials:
References: