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NCT Number: NCT06727669

Longitudinal Cohort of Thrombosis and Hemostasis Diseases

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.

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Key information

Conditions

Immune Thrombocytopenia Arterial Thromboembolism Autoimmune Diseases Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Cardiovascular Diseases Coagulation Factor Deficiency Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytopenia Deep Vein Thrombosis Disseminated Intravascular Coagulation Embolism Embolism and Thrombosis Factor 8 deficiency, acquired Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia A, Acquired Hemophilia B Hemophilia B, Acquired Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Dysfunction Pulmonary Embolism Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombotic Thrombocytopenic Respiratory Tract Diseases Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombophilia Thrombosis Thrombotic Microangiopathies Thrombotic Thrombocytopenic Purpura Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence

    Time frame: 5 years

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

  2. Distribution

    Time frame: 5 years

    The population characteristics of thrombosis and hemostasis diseases

  3. 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.

  4. Long-term overall remission rate

    Time frame: 1 years

    Proportion of the participants with an overall remission.

  5. Safety of treatment

    Time frame: 1 years

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

  6. Health economic evaluation

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Haixia Fu, MD

CONTACT

[email protected]

086-01088326002

Zhuoyu An

CONTACT

086-01088326001

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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