National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia

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.

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Key information

Conditions

AIHA - Warm Autoimmune Hemolytic Anemia AIHA - Cold Autoimmune Hemolytic Anemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Autoimmune Hemolytic Anemia Mixed Type Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Red Blood Cell Diseases Center and Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Lele Zhang, PhD

CONTACT

[email protected]

15811139278

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Hematologic response

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.

Hematologic response contains improvements in hemoglobin.

Study contacts

Contact information is provided by the study sponsor or research team.

Lele Zhang, PhD

CONTACT

[email protected]

‭15811139278‬

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Acronym: NICHE-AIHA

Important dates

Study start: 2001
Primary completion: 2070
Study completion: 2070
First posted: Jun 13, 2025
Registry last updated: Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting