National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia

NCT07019038 | Recruiting

• 1 other identifier: IIT2025042
• Study Type: observational
• Target: 9,999
• Locations: 1 country
• Sites: 1

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. 1.Analyze the demographic and clinical characteristics of patients with AIHA, including sex, age, disease severity, and other relevant factors.
2. 2.Examine disease features of AIHA patients, such as biochemical and hematological indicators
3. 3.Assess treatment patterns and real-world effectiveness in AIHA patients.
4. 4.Evaluate clinical outcomes, including hematologic response, relapse, and mortality
5. 5.Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.

Conditions

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

Keywords

Autoimmune Hemolytic Anemia; Treatment patterns; Hematologic response

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

NICHE-AIHA

Patients who were diagnosed with AIHA in the investigating hospitals from Jan 1, 2001.

Other: A combined retrospective and prospective observational follow-up

Interventions

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.

NICHE-AIHA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Red Blood Cell Diseases Center and Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Lele Zhang, PhD

CONTACT

‭15811139278‬; zhanglele@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 13, 2025
• Study Start: January 1, 2001
• Primary Completion (Estimated): December 31, 2070
• Study Completion (Estimated): December 31, 2070
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)