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临床试验/NCT06727669
NCT06727669招募中不适用

Longitudinal Cohort of Thrombosis and Hemostasis Diseases

Peking University People's Hospital5 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
5
主要终点
Prognosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who were diagnosed as thrombosis and hemostasis diseases.

排除标准

  • 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.

结局指标

主要结局

Prognosis

时间窗: 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.

次要结局

  • Incidence(5 years)
  • Distribution(5 years)
  • Overall response rate(180 days)
  • Long-term overall remission rate(1 years)
  • Safety of treatment(1 years)
  • Health economic evaluation(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiao Hui Zhang

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

Peking University People's Hospital

研究点 (5)

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