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| Name | Class |
|---|---|
| Jiangsu Provincial People's Hospital | OTHER |
| Wuhan TongJi Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort. | ||
| Prospective cohort | Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort. | ||
| Retrospective/Prospective cohort | Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prognosis | To analyze the long-term prognosis of patients with immune thrombocytopenia (ITP), and analyze the risk factors associated with their prognosis. | 5 years |
| Overall response rate | To analyze the therapeutic efficacy of patients with ITP, and analyze the impact factors associated with the efficacy. | 180 days |
| Long-term overall remission rate | Proportion of the participants with an overall remission. | 1 year |
| Comorbidities | The incidence, risk factors, treatments, and prognosis of complications | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence | To describe the incidence of ITP, and analyze the risk factors associated with these diseases. | 5 years |
| Safety of treatment | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with confirmed immune thrombocytopenia (ITP).
Diagnostic Criteria for ITP:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Wu, MD | Contact | 086-01088326002 | wujin1996@126.com | |
| Li-Qin Cao, MD | Contact | 086-01088326002 | caoliqin@pkuph.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Hui Zhang, MD | Peking University Institute of Hematology, Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing 100010 | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114623 | Derived | Zhang L, An Z, Zhao P, Huang Q, Wu J, He Y, Zhu X, Fu H, Zhang Y, Kong Y, Jiang Q, Jiang H, Lu J, Chang Y, Xu L, Zhao X, Huang X, Zhang X. Unmasking the link: pulmonary embolism risk and outcomes in adults with immune thrombocytopenia. J Thromb Haemost. 2026 May 9:S1538-7836(26)00281-3. doi: 10.1016/j.jtha.2026.04.030. Online ahead of print. |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| 1 year |
| Health economic evaluation | To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases | 5 years |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |