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Longitudinal Cohort Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07070193
Enrollment
500
Registered
2025-07-17
Start date
2025-07-10
Completion date
2036-12-31
Last updated
2025-07-17

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

Conditions

Acute Ischemic Stroke, Immune Thrombocytopenia (ITP)

Keywords

Immune Thrombocytopenia, Acute Ischemic Stroke

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Diagnosed with immune thrombocytopenia, and subsequently identified patients with acute ischemic stroke. 2. Since January 1, 2005, patients who received treatment at Peking University People's Hospital.

Exclusion criteria

1. For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable; 2. Patients deemed unsuitable for the study by the researchers.

Design outcomes

Primary

MeasureTime frameDescription
Prognosis5 yearsTo 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

MeasureTime frameDescription
Long-term overall remission rate1 yearProportion of the participants with an overall remission.
Comorbidities5 yearsThe incidence, risk factors, treatments, and prognosis of complications
Overall response rate180 daysTo analyze the therapeutic efficacy of patients with ITP with AIS, and analyze the impact factors associated with the efficacy.
Safety of treatment1 yearNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Health economic evaluation5 yearsTo perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases
Incidence5 yearsTo describe the incidence of ITP and AIS, and analyze the risk factors associated with these diseases.

Contacts

Primary ContactLi-Qin Cao, MD
caoliqin@pkuph.edu.cn086-01088326002
Backup ContactJin Wu, MD
wujin1996@126.com086-01088326002

Outcome results

None listed

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