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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NICHE-AIHA | Patients who were diagnosed with AIHA in the investigating hospitals from Jan 1, 2001. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A combined retrospective and prospective observational follow-up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hematologic response | Hematologic response contains improvements in hemoglobin. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lele Zhang, PhD | Contact | â€15811139278‬ | zhanglele@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Blood Cell Diseases Center and Regenerative Medicine Center | Recruiting | Tianjin | Tianjin Municipality | China |
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|
| ID | Term |
|---|---|
| D000744 | Anemia, Hemolytic, Autoimmune |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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