Longitudinal Cohort of Thrombosis and Hemostasis Diseases

NCT06727669 | Recruiting

• 1 other identifier: 2024PHB401-001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• Prognosis

  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.

  5 years

Secondary Outcomes (6)

• Incidence

  5 years

• Distribution

  5 years

• Overall response rate

  180 days

• Long-term overall remission rate

  1 years

• Safety of treatment

  1 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who were diagnosed as thrombosis and hemostasis diseases.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (5)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Department of Hematology, Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Department of Hematology, Beijing Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

Xinqiao Hospital, Army Military Medical University

Chongqing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombotic Thrombocytopenic; Factor 8 deficiency, acquired; Disseminated Intravascular Coagulation; Thrombophilia; Venous Thrombosis; Pulmonary Embolism; Thrombotic Microangiopathies; Hemophilia A; Hemophilia B; Hemostatic Disorders; Thrombosis

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Xiao-Hui Zhang, MD

  Peking University Institute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haixia Fu, MD

CONTACT

086-01088326002; fuhaixia_210@163.com

Zhuoyu An

CONTACT

086-01088326001

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 11, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

CN (5)