Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07070193

Longitudinal Cohort Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke

Immune thrombocytopenia (ITP) is an acquired bleeding disorder mediated by immune-related platelet destruction and impaired platelet production. Immune thrombocytopenia may increase the risk of cerebral infarction and represents a relatively uncommon etiology of acute ischemic stroke. This disease is associated with high disability and mortality rates, poses significant therapeutic challenges, and constitutes a serious threat to human health. Therefore, research on the diagnosis, treatment, and prognosis of ITP combined with acute ischemic stroke is of great significance for improving patients' quality of life and survival outcomes. However, most current hematologic cohort studies are based on single-center or limited multicenter sample sizes, lacking comprehensive and large-scale prospective cohort studies. Our center plans to conduct a large-sample, combined retrospective and prospective longitudinal cohort study. This study will register patients' basic information and diagnosis, follow up with patients through questionnaires, telephone calls, video consultations, online platforms, and in-person visits to record treatment and comorbidity data, collect prognostic information, and retrieve hospitalization and outpatient costs through medical record systems. The study aims to provide comprehensive data on the incidence, treatment, prognosis, and healthcare costs of ITP patients with acute ischemic stroke in China.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

Immune thrombocytopenia (ITP) is an immune-mediated acquired bleeding disorder characterized by thrombocytopenia, with normal or increased megakaryocyte counts in the bone marrow but impaired maturation. The estimated incidence in the general population is approximately 2 to 5 cases per 100,000 individuals. The primary clinical manifestation of ITP is bleeding, ranging from mild skin/mucosal bleeding to life-threatening organ hemorrhage. However, some patients also face an increased risk of thrombosis/embolism. Embolic events in critical organs such as the heart and brain can severely impact patients' quality of life and lead to life-threatening complications.

In China, there are approximately 3.94 million new stroke cases annually, of which acute ischemic stroke (AIS) is the most common type, accounting for 69.6% to 72.8% of all new stroke cases. From an epidemiological perspective, AIS is a globally prevalent disease that significantly affects the quality of life and physical health across populations.

Research indicates that immune thrombocytopenia increases the risk of cerebral infarction and represents a relatively uncommon but important etiological factor for acute ischemic stroke. Currently, most cohort studies on ITP in China are either single-center studies or limited multicenter studies with small sample sizes, resulting in insufficient data and a lack of large-scale, longitudinal prospective cohort studies.

This study is a multicenter, retrospective and prospective longitudinal observational study that will enroll patients diagnosed with ITP and concurrent acute ischemic stroke. It will collect baseline patient information and diagnostic data, conduct regular prospective follow-ups via questionnaires, telephone interviews, video consultations, online platforms, and in-person visits, and record treatment regimens, comorbidities, and prognostic outcomes. Additionally, hospitalization and outpatient costs will be extracted from medical records. The study aims to provide comprehensive data on the epidemiology, treatment patterns, clinical outcomes, and healthcare costs of ITP patients with AIS in China, ultimately supporting the development of novel diagnostic and therapeutic strategies and improving long-term bleeding-free survival rates.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed with immune thrombocytopenia, and subsequently identified patients with acute ischemic stroke.
  • Since January 1, 2005, patients who received treatment at Peking University People's Hospital.

Exclusion criteria

  • For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable;
  • Patients deemed unsuitable for the study by the researchers.

Treatment and study plan

Primary outcomes

  1. Prognosis

    Time frame: 5 years

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

Secondary outcomes

  1. Overall response rate

    Time frame: 180 days

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

  2. Long-term overall remission rate

    Time frame: 1 year

    Proportion of the participants with an overall remission.

  3. Comorbidities

    Time frame: 5 years

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

  4. Incidence

    Time frame: 5 years

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

  5. Safety of treatment

    Time frame: 1 year

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

  6. 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

  • Affiliated Hospital of Fujian Medical University, Xiehe Branch
  • Army Medical University, China
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Henan Cancer Hospital
  • Huazhong Science & Technology Shanxi Baiqiu En Hospital
  • Jiangsu province hospital of TCM
  • Kunming Medical University Second Affiliated Hospital
  • NORTHERN JIANGSU PEOPLE'S HOSPITAL 1900
  • North China University of Science and Technology
  • Qilu Hospital of Shandong University
  • Second Xiangya Hospital of Central South University
  • Shanghai Zhongshan Hospital
  • Southern Medical University, China
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The Affiliated People's Hospital of Ningbo University
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of University of Science and Technology of China
  • The Second Hospital of Hebei Medical University
  • The Third Xiangya Hospital of Central South University
  • Tongji Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Xuzhou Medical University Affiliated Hospital of Huaian
  • Zhejiang University

Registry information

Official study title

Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke

Important dates

Study start
2025
Primary completion
2035
Study completion
2036
First posted
Jul 17, 2025
Registry last updated
Jul 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.

Published trials that share one or more normalized conditions with this study.