Longitudinal Cohort Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke

NCT07070193 | Not Yet Recruiting DMC

• 1 other identifier: ITP-AIS2025
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immune Thrombocytopenia (ITP); Acute Ischemic Stroke

Keywords

Immune Thrombocytopenia; Acute Ischemic Stroke

Outcome Measures

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.

  5 years

Secondary Outcomes (6)

• Overall response rate

  180 days

• Long-term overall remission rate

  1 year

• Comorbidities

  5 years

• Incidence

  5 years

• Safety of treatment

  1 year

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Jiangsu province hospital of TCM: collaborator
• Army Medical University, China: collaborator
• Henan Cancer Hospital: collaborator
• Ningbo University Affiliated People's Hospital: 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, Affiliated to Tongji Medical College of Huazhong University of Science and Technology: 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 Hospital Affiliated to 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

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Ischemic Stroke

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiao-Hui Zhang, MD

  eking University Institute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Qin Cao, MD

CONTACT

086-01088326002; caoliqin@pkuph.edu.cn

Jin Wu, MD

CONTACT

086-01088326002; wujin1996@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2036
• Last Updated: July 17, 2025

Record last verified: 2025-07