Arterial Thromboembolism, Bleeding Disorder, Coagulation Factor Deficiency, Deep Vein Thrombosis, Disseminated Intravascular Coagulation, Hemophilia A, Hemophilia A, Acquired, Hemophilia B, Hemophilia B, Acquired, Immune Thrombocytopenia, Platelet Dysfunction, Pulmonary Embolism, Thrombophilia, Thrombosis, Thrombotic Microangiopathies, Thrombotic Thrombocytopenic Purpura
Conditions
Keywords
Thrombosis, Hemostasis
Brief summary
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
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.
Interventions
None listed
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prognosis | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence | 5 years | To describe the incidence of thrombosis and hemostasis diseases, and analyze the risk factors associated with these diseases. |
| Overall response rate | 180 days | To analyze the therapeutic efficacy of patients with thrombosis and hemostasis diseases, and analyze the impact factors associated with the efficacy. |
| Distribution | 5 years | The population characteristics of thrombosis and hemostasis diseases |
| Safety of treatment | 1 years | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |
| Health economic evaluation | 5 years | To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases |
| Long-term overall remission rate | 1 years | Proportion of the participants with an overall remission. |
Countries
China
Contacts
Primary ContactHaixia Fu, MD
Backup ContactZhuoyu An
Outcome results
None listed