About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with confirmed diagnosis of ITP
Patients treated at Peking University People's Hospital since January 1, 2005
Disqualifiers
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"
Trial population
Patients with confirmed immune thrombocytopenia (ITP). Diagnostic Criteria for ITP: 1. Sustained platelet count \<100×10⁹/L 2. Normal or increased megakaryocyte count in bone marrow with maturation defects 3. Exclusion of other potential causes of thrombocytopenia including: pseudothrombocytopenia, drug-induced thrombocytopenia, viral infections, helicobacter pylori infection, hematologic disorders, autoimmune diseases, hypersplenism, malignancies
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prognosis
To analyze the long-term prognosis of patients with immune thrombocytopenia (ITP), and analyze the risk factors associated with their prognosis.
Overall response rate
To analyze the therapeutic efficacy of patients with ITP, and analyze the impact factors associated with the efficacy.
Long-term overall remission rate
Proportion of the participants with an overall remission.
Comorbidities
The incidence, risk factors, treatments, and prognosis of complications
Secondary outcomes
Incidence
To describe the incidence of ITP, and analyze the risk factors associated with these diseases.
Safety of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Health economic evaluation
To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases
Sponsors and contacts
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Peking University People's Hospital
Lead sponsor
Jiangsu Provincial People's Hospital
Collaborator
Wuhan TongJi Hospital
Collaborator
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