National longitudinal cohort of autoimmune hemolytic anemia in China
National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
This project will follow people with warm, cold, or mixed autoimmune hemolytic anemia treated at a major Tianjin hematology center to see what treatments they receive and how well they do over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9999 (estimated) |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07019038 on ClinicalTrials.gov |
What this trial studies
This observational cohort combines retrospective data and prospective follow-up of patients with warm, cold, or mixed autoimmune hemolytic anemia seen at the Institute of Hematology & Blood Diseases Hospital in Tianjin. Investigators will collect demographic and clinical characteristics, biochemical and hematologic indicators, treatment patterns, clinical outcomes (hematologic response, relapse, mortality), long-term post-discontinuation outcomes, and healthcare costs. Retrospective inclusion will cover patients treated since January 1, 2001, while prospective follow-up will monitor ongoing outcomes and resource use. Analyses will describe incidence, identify risk factors, and examine real-world effectiveness of therapies and associations with prognosis.
Who should consider this trial
Good fit: People diagnosed with warm, cold, or mixed autoimmune hemolytic anemia with hemoglobin below 100 g/L who have been treated at the Institute of Hematology & Blood Diseases Hospital (Tianjin) since January 1, 2001 are the intended participants.
Not a fit: Patients who cannot commit to long-term follow-up, have severe comorbidities or substance dependence that limit reliable data collection, or who were not treated at the enrolling center are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, the cohort could clarify which treatments and patient factors are linked to better blood responses and long-term outcomes, helping guide clinical care and resource planning in China.
How similar studies have performed: Prior smaller single-center and multi-center cohorts have informed AIHA natural history and treatment patterns, but large-scale prospective national cohorts in China are scarce and this approach is relatively novel there.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin Municipality
- Red Blood Cell Diseases Center and Regenerative Medicine Center — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lele Zhang, PhD
- Email: zhanglele@ihcams.ac.cn
- Phone: 15811139278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.