Longitudinal Observational Study on Immune Thrombocytopenia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 3 trial groups
Group A: Retrospective cohort
Group B: Prospective cohort
Group C: Retrospective/Prospective cohort

Trial outcomes

Primary outcomes

1

Prognosis

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

Time frame
5 years
2

Overall response rate

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

Time frame
180 days
3

Long-term overall remission rate

Proportion of the participants with an overall remission.

Time frame
1 year
4

Comorbidities

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

Time frame
5 years

Secondary outcomes

1

Incidence

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

Time frame
5 years
2

Safety of treatment

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

Time frame
1 year
3

Health economic evaluation

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Jiangsu Provincial People's Hospital

Collaborator

Wuhan TongJi Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: