Clinical trial NCT06727669: Longitudinal Cohort of Thrombosis and Hemostasis Diseases
Official title: Longitudinal Cohort of Thrombosis and Hemostasis Diseases
Study type: OBSERVATIONAL
Overall status: 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
Hemophilia B
Hemophilia B, Acquired
Platelet Dysfunction
Arterial Thromboembolism
Bleeding Disorder
Thrombosis
Keywords: Thrombosis
Hemostasis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed as thrombosis and hemostasis diseases, including immune thrombocytopenia, 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, thrombocytopenia and coagulation abnormalities after hematopoietic stem cell transplantation, hereditary and acquired thrombophilia,hereditary hemorrhagic disease , et al.

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.

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.

Primary outcomes:
measure: Prognosis
timeFrame: 5 years
Secondary outcomes:
measure: Incidence
timeFrame: 5 years
measure: Distribution
timeFrame: 5 years
measure: Overall response rate
timeFrame: 180 days
measure: Long-term overall remission rate
timeFrame: 1 years
measure: Safety of treatment
timeFrame: 1 years
measure: Health economic evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Insititute of Hematology, Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Hematology, Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of Hematology, Beijing Hospital
state: Beijing
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Chongqing
country: China
facility: Xinqiao Hospital, Army Military Medical University
Study officials:
affiliation: Peking University Institute of Hematology, Peking University People's Hospital
name: Xiao-Hui Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: