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NCT Number: NCT07068425

Longitudinal Observational Study on Immune Thrombocytopenia

Immune Thrombocytopenia (ITP) is a bleeding disorder characterized by immune-mediated destruction and/or impaired production of platelets, leading to clinical manifestations such as petechiae, purpura, mucosal bleeding, and in severe cases, life-threatening visceral or intracranial hemorrhage. Research on the diagnosis, treatment, and prognosis of ITP is critical for improving patient outcomes and quality of life. However, most existing hematologic cohort studies are limited to single-center or small multicenter samples, lacking comprehensive, large-scale prospective investigations.

To address this gap, our center plans to conduct a large-sample, combined retrospective and prospective longitudinal observational cohort study of ITP patients. The study will enroll patients to collect baseline demographic and diagnostic data, followed by longitudinal follow-up via questionnaires, telephone interviews, video consultations, online platforms, and in-person visits. Key variables including treatment regimens, comorbidities, and prognostic outcomes will be systematically recorded. Additionally, hospitalization and outpatient expenditure data will be extracted from electronic medical records.

This study aims to provide high-quality real-world evidence on the epidemiology, treatment patterns, clinical outcomes, and healthcare costs of ITP patients in China, ultimately informing clinical decision-making and health policy.

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Key information

Conditions

Immune Thrombocytopenia (ITP) Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing 100010

Beijing, China

About this study

Immune Thrombocytopenia (ITP) is an immune-mediated acquired bleeding disorder characterized by thrombocytopenia with normal or increased megakaryocytes in the bone marrow accompanied by maturation defects. Epidemiological studies estimate its incidence at approximately 2-5 cases per 100,000 individuals in the general population.

The primary clinical manifestation of ITP is bleeding, ranging from minor cutaneous/mucosal hemorrhage to life-threatening organ bleeding. Notably, some patients also exhibit increased risk of thrombotic/embolic events. Embolic complications in critical organs (e.g., heart, brain) may significantly impair quality of life and lead to life-threatening conditions.

Currently, most ITP cohort studies in China are limited to single-center designs or small multicenter studies with insufficient sample sizes. There remains a notable lack of large-scale, longitudinal prospective cohort studies.

To address these limitations, this multicenter, retrospective-prospective longitudinal observational study will enroll diagnosed ITP patients to systematically collect:

Baseline demographic and diagnostic data Prospective follow-up data via questionnaires, telemedicine, and clinical visits Treatment regimens, comorbidities, and prognostic outcomes Healthcare utilization costs through electronic medical records

By establishing this comprehensive real-world database, the study aims to:

Elucidate the epidemiology, treatment patterns, and economic burden of ITP in China Provide evidence-based support for developing novel clinical strategies Improve long-term hemorrhage-free survival rates This investigation will serve as a foundational platform for optimizing ITP management and enhancing patient outcomes across China.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with confirmed diagnosis of ITP
  • Patients treated at Peking University People's Hospital since January 1, 2005

Exclusion criteria

  • Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders"
  • Patients deemed ineligible for the study by investigators"

Treatment and study plan

Primary outcomes

  1. Prognosis

    Time frame: 5 years

    To analyze the long-term prognosis of patients with immune thrombocytopenia (ITP), and analyze the risk factors associated with their prognosis.

  2. Overall response rate

    Time frame: 180 days

    To analyze the therapeutic efficacy of patients with ITP, and analyze the impact factors associated with the efficacy.

  3. Long-term overall remission rate

    Time frame: 1 year

    Proportion of the participants with an overall remission.

  4. Comorbidities

    Time frame: 5 years

    The incidence, risk factors, treatments, and prognosis of complications

Secondary outcomes

  1. Incidence

    Time frame: 5 years

    To describe the incidence of ITP, and analyze the risk factors associated with these diseases.

  2. Safety of treatment

    Time frame: 1 year

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

  3. Health economic evaluation

    Time frame: 5 years

    To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases

Study contacts

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

Jin Wu, MD

CONTACT

[email protected]

086-01088326002

Li-Qin Cao, MD

CONTACT

[email protected]

086-01088326002

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Jiangsu Provincial People's Hospital
  • Wuhan TongJi Hospital

Registry information

Official study title

Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia

Important dates

Study start
2025
Primary completion
2035
Study completion
2036
First posted
Jul 16, 2025
Registry last updated
Jul 16, 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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