Longitudinal Cohort of Thrombosis and Hemostasis Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia, Thrombotic Thrombocytopenic Purpura, Hemophilia A, Acquired, Disseminated Intravascular Coagulation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Prognosis [Time frame: 5 years]
Secondary outcome measures (6)
- Incidence [Time frame: 5 years]
- Distribution [Time frame: 5 years]
- Overall response rate [Time frame: 180 days]
- Long-term overall remission rate [Time frame: 1 years]
- Safety of treatment [Time frame: 1 years]
- Health economic evaluation [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 5 centers
- Peking University Insititute of Hematology, Peking University People's Hospital — Beijing
- Department of Hematology, Beijing Friendship Hospital, Capital Medical University — Beijing
- Department of Hematology, Beijing Hospital — Beijing
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
- Xinqiao Hospital, Army Military Medical University — Chongqing
Identifiers
NCT: NCT06727669 · 2024PHB401-001