Longitudinal Cohort of Thrombosis and Hemostasis Diseases

Recruiting

• Conditions: Immune Thrombocytopenia; Thrombotic Thrombocytopenic Purpura; Hemophilia A, Acquired; Disseminated Intravascular Coagulation; Thrombophilia; Deep Vein Thrombosis; Pulmonary Embolism; Thrombotic Microangiopathies; Coagulation Factor Deficiency; Hemophilia A

• Registration Number: NCT06727669
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence	5 years	To describe the incidence of thrombosis and hemostasis diseases, and analyze the risk factors associated with these diseases.
Distribution	5 years	The population characteristics of thrombosis and hemostasis 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.
Long-term overall remission rate	1 years	Proportion of the participants with an overall remission.
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

Trial Locations

Locations (5)

Peking University Insititute of Hematology, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Department of Hematology, Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Department of Hematology, Beijing Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Xinqiao Hospital, Army Military Medical University; 🇨🇳 Chongqing, China