Longitudinal Cohort of Thrombosis and Hemostasis Diseases

December 5, 2024 updated by: Xiao Hui Zhang, Peking University People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhuoyu An
  • Phone Number: 086-01088326001

Study Locations

  • China
      • Chongqing, China
        • Not yet recruiting
        • Xinqiao Hospital, Army Military Medical University
        • Contact:
          • Xi Zhang
    • Beijing
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Peking University Insititute of Hematology, Peking University People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaohui Zhang
      • Beijing, Beijing, China
        • Not yet recruiting
        • Department of Hematology, Beijing Friendship Hospital, Capital Medical University
        • Contact:
          • Zhao Wang
      • Beijing, Beijing, China
        • Not yet recruiting
        • Department of Hematology, Beijing Hospital
        • Contact:
          • Hui Liu
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Zhongxing Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed as thrombosis and hemostasis diseases, including immune thrombocytopenia, thrombotic thrombocytopenic purpura, hereditary and acquired Hemophilia, disseminated intravascular coagulation, 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, hereditary and acquired thrombophilia,hereditary hemorrhagic disease , et al.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognosis
Time Frame: 5 years
To analyze the long-term prognosis of patients with thrombosis and hemostasis diseases, such as immune thrombocytopenia (ITP),thrombotic thrombocytopenic purpura, hereditary and acquired hemophilia, disseminated intravascular coagulation, pregnancy With ITP, pregnancy With prethrombotic state (such as protein C, protein S deficiency, etc.), deep vein thrombosis, pulmonary embolism, thrombotic microangiopathies, thrombocytopenia or coagulation abnormalities after hematopoietic stem cell transplantation, hereditary and acquired thrombophilia, platelet dysfunction,arterial thromboembolism, and hereditary hemorrhagic disease , et al., and analyze the risk factors associated with their prognosis.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence
Time Frame: 5 years
To describe the incidence of thrombosis and hemostasis diseases, and analyze the risk factors associated with these diseases.
5 years
Distribution
Time Frame: 5 years
The population characteristics of thrombosis and hemostasis diseases
5 years
Overall response rate
Time Frame: 180 days
To analyze the therapeutic efficacy of patients with thrombosis and hemostasis diseases, and analyze the impact factors associated with the efficacy.
180 days
Long-term overall remission rate
Time Frame: 1 years
Proportion of the participants with an overall remission.
1 years
Safety of treatment
Time Frame: 1 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
1 years
Health economic evaluation
Time Frame: 5 years
To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Xiao-Hui Zhang, MD, Peking University Institute of Hematology, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PHB401-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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