Skip to content

National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia

National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07019038
Acronym
NICHE-AIHA
Enrollment
9999
Registered
2025-06-13
Start date
2001-01-01
Completion date
2070-12-31
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIHA - Cold Autoimmune Hemolytic Anemia, AIHA - Warm Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia Mixed Type

Keywords

Autoimmune Hemolytic Anemia, Treatment patterns, Hematologic response

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.

Interventions

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.

Sponsors

Institute of Hematology & Blood Diseases Hospital, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hematologic responseAssessments 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.

Countries

China

Contacts

Primary ContactLele Zhang, PhD
zhanglele@ihcams.ac.cn‭15811139278‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026