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Longitudinal Cohort of Thrombosis and Hemostasis Diseases

NCT ID: NCT06727669

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2030-12-31

Brief Summary

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This is a multicenter, prospective, longitudinal, observational cohort study to investigate thrombosis and hemostasis diseases in Chinese patients. This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records.The incidence and risk factors of thrombosis and hemostasis diseases, the treatment methods, prognosis and medical expenses of these patients in China will be analyzed. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Detailed Description

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Thrombosis and hemostasis diseases are a group of high-risk hematological diseases, characterized by bleeding or hypercoagulability caused by congenital or acquired abnormalities in hemostasis, coagulation, and fibrinolysis. Thrombosis and hemostasis diseases included various bleeding and thrombotic diseases such as primary immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia, disseminated intravascular coagulation (DIC), thrombophilia, pregnancy with ITP, pregnancy with prethrombotic state (such as protein C, protein S deficiency, etc.), deep vein thrombosis, pulmonary embolism, thrombocytopenia and coagulation abnormalities after hematopoietic stem cell transplantation, and so on. Thrombosis and hemostasis diseases have a high incidence rate, may affect patients' quality of life and even are associated with the poor survival. However, current studies are mostly based on data from limited sample size cohorts, lacking comprehensive and large-scale prospective cohort studies.

This is a multicenter, prospective, longitudinal, observational cohort study investigating the incidence and risk factors of thrombosis and hemostasis diseases, and to analyze the treatment methods, prognosis and medical expenses of these patients in China.This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Conditions

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Immune Thrombocytopenia Thrombotic Thrombocytopenic Purpura Hemophilia A, Acquired Disseminated Intravascular Coagulation Thrombophilia Deep Vein Thrombosis Pulmonary Embolism Thrombotic Microangiopathies Coagulation Factor Deficiency Hemophilia A Hemophilia B Hemophilia B, Acquired Platelet Dysfunction Arterial Thromboembolism Bleeding Disorder Thrombosis

Keywords

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Thrombosis Hemostasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients who were diagnosed as thrombosis and hemostasis diseases.

Exclusion Criteria

* Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.
* Patients with alcohol and drug addictions or mental illness affect their ability to comply with study requirements.
* According to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao Hui Zhang

Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-Hui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Department of Hematology, Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Department of Hematology, Beijing Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Xinqiao Hospital, Army Military Medical University

Chongqing, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Haixia Fu, MD

Role: CONTACT

Phone: 086-01088326002

Email: [email protected]

Zhuoyu An

Role: CONTACT

Phone: 086-01088326001

Facility Contacts

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Xiao Hui Zhang, MD

Role: primary

Haixia Fu, MD

Role: backup

Zhao Wang

Role: primary

Hui Liu

Role: primary

Zhongxing Jiang

Role: primary

Xi Zhang

Role: primary

Other Identifiers

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2024PHB401-001

Identifier Type: -

Identifier Source: org_study_id