Longitudinal Cohort Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke

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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with confirmed immune thrombocytopenia (ITP) combined with acute ischemic stroke(AIS) 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 Diagnostic Criteria for AIS: 1. Acute onset; 2. Focal neurological deficits (weakness or numbness of one side of the face or limb, language disorders, etc.), with a few cases presenting with comprehensive neurological deficits; 3. The presence of a responsible lesion on imaging or the symptoms/signs persisting for more than 24 hours; 4. Elimination of non-vascular causes; 5. Brain CT/MRI ruling out cerebral hemorrhage.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

500 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) combined with acute ischemic stroke, and analyze the risk factors associated with their prognosis.

Time frame
5 years

Secondary outcomes

1

Overall response rate

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

Time frame
180 days
2

Long-term overall remission rate

Proportion of the participants with an overall remission.

Time frame
1 year
3

Comorbidities

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

Time frame
5 years
4

Incidence

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

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University People's Hospital

Lead sponsor

Jiangsu province hospital of TCM

Collaborator

Army Medical University, China

Collaborator

Henan Cancer Hospital

Collaborator

The Affiliated People's Hospital of Ningbo University

Collaborator

West China Hospital

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

Zhejiang University

Collaborator

The Second Hospital Of Hebe Medical University

Collaborator

Kunming Medical University Second Affiliated Hospital

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Huazhong Science & Technology Shanxi Baiqiu En Hospital

Collaborator

NORTHERN JIANGSU PEOPLE'S HOSPITAL 1900

Collaborator

Tongji Hospital

Collaborator

Xuzhou Medical University Affiliated Hospital of Huaian

Collaborator

Affiliated Hospital of Fujian Medical University, Xiehe Branch

Collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Xiangya Hospital of Central South University

Collaborator

Qilu Hospital of Shandong University

Collaborator

Southern Medical University - Southern Hospital

Collaborator

The Second Hospital of Hebei Medical University

Collaborator

The First Affiliated Hospital of University of Science and Technology of China

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

North China University of Science and Technology

Collaborator

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