ClinicalTrials.gg
RecruitingNCT06727669Updated Dec 11, 2024

Longitudinal Cohort of Thrombosis and Hemostasis Diseases

An observational study in Immune Thrombocytopenia, Thrombotic Thrombocytopenic Purpura and Hemophilia A, Acquired, sponsored by Peking University People's Hospital. Recruiting at 5 sites in China. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by Peking University People's Hospital · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Purpura, Thrombocytopenic, Idiopathic

503 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 122 across 99 observational studies indexed under Purpura, Thrombocytopenic, Idiopathic.

Browse Purpura, Thrombocytopenic, Idiopathic studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who were diagnosed as thrombosis and hemostasis diseases.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

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.

    Time frame: 5 years

Secondary outcomes

  1. Incidence

    To describe the incidence of thrombosis and hemostasis diseases, and analyze the risk factors associated with these diseases.

    Time frame: 5 years

  2. Distribution

    The population characteristics of thrombosis and hemostasis diseases

    Time frame: 5 years

  3. Overall response rate

    To analyze the therapeutic efficacy of patients with thrombosis and hemostasis diseases, and analyze the impact factors associated with the efficacy.

    Time frame: 180 days

  4. Long-term overall remission rate

    Proportion of the participants with an overall remission.

    Time frame: 1 years

  5. Safety of treatment

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

    Time frame: 1 years

  6. Health economic evaluation

    To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases

    Time frame: 5 years

07

Study locations

1 of 5 sites recruiting
  • Peking University Insititute of Hematology, Peking University People's Hospital
    Beijing, Beijing 100010, China
    Recruiting
  • Department of Hematology, Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing, China
    Not yet recruiting
    • Zhao Wang · Contact
  • Department of Hematology, Beijing Hospital
    Beijing, Beijing, China
    Not yet recruiting
    • Hui Liu · Contact
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
    Not yet recruiting
    • Zhongxing Jiang · Contact
  • Xinqiao Hospital, Army Military Medical University
    Chongqing, China
    Not yet recruiting
    • Xi Zhang · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06727669
Responsible party
Xiao Hui Zhang (Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital, Peking University People's Hospital) — Principal investigator
First posted
Dec 11, 2024
Start date
Nov 1, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Dec 11, 2024

Study contacts

Haixia Fu, MD
Contact
fuhaixia_210@163.com
086-01088326002
Zhuoyu An
Contact
086-01088326001
Xiao-Hui Zhang, MD
principal investigator · Peking University Institute of Hematology, Peking University People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion