National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Subjects diagnosed with AIHA.

Hemoglobin<100g/L

Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2001.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • A combined retrospective and prospective observational follow-up

    Other intervention

    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.

Treatment groups

9,999 Participants
are divided into 1 treatment group
Group A: NICHE-AIHA1 intervention

Trial outcomes

Primary outcomes

1

Hematologic response

Hematologic response contains improvements in hemoglobin.

Time frame
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

Sponsors and contacts

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