ClinicalTrials.gov record NCT06727669
Longitudinal Cohort of Thrombosis and Hemostasis Diseases
Longitudinal Cohort of Thrombosis and Hemostasis Diseases
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A multicenter, prospective observational cohort collecting medical records and patient questionnaires for people diagnosed with thrombosis and hemostasis diseases. Participants are followed over time (target about 5 years) so researchers can describe incidence, risk factors, treatments, prognosis, and medical costs.
What it is studying. The study is collecting clinical data, patient-reported exposure information, and follow-up outcomes to describe how often these thrombosis and hemostasis conditions occur, what risk factors are associated with them, which treatments are used, patients' prognosis over time, and the medical costs.
What the researchers hope to learn. To describe the incidence and population characteristics of thrombosis and hemostasis diseases; to identify risk factors; to analyze treatment methods and therapeutic outcomes (overall response and long-term remission rates); to assess treatment safety; and to evaluate hospital stay and hospitalization costs.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants allow study staff to collect information from their medical records (basic details, diagnoses, treatments, and medical expense or hospital cost data). They complete questionnaires about exposures and risk factors. They are followed prospectively to record prognosis and outcomes, with follow-up planned up to about 5 years. The registry does not list any required invasive study procedures beyond information collection and questionnaires.
How the study is structured. A prospective observational cohort study. The study will collect information from medical records, use questionnaires to record exposures, and follow participants over time (target duration 5 years). No experimental treatments are assigned.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on thrombotic thrombocytopenic purpura
Important dates
- Study start
- Nov 1, 2024
- Primary completion
- Dec 31, 2029 (estimated)
- Study completion
- Dec 31, 2030 (estimated)
- Target enrollment
- 3000 participants (estimated)
- Last updated on registry
- Dec 11, 2024
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Peking University People's Hospital
- Principal investigator
- Xiao Hui Zhang, Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital
Peking University People's Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Haixia Fu, MD 📞 086-01088326002 ✉ fuhaixia_210@163.com
- Zhuoyu An 📞 086-01088326001
Participating sites (5)
- Peking University Insititute of Hematology, Peking University People's HospitalRecruiting
Beijing, Beijing Municipality, 100010 · China
- Xiao Hui Zhang, MD · zhangxh100@sina.com
- Haixia Fu, MD · 086-01088326002 · fuhaixia_210@163.com
- Xiaohui Zhang
- Department of Hematology, Beijing Friendship Hospital, Capital Medical UniversityNot Yet Recruiting
Beijing, Beijing Municipality · China
- Zhao Wang
- Department of Hematology, Beijing HospitalNot Yet Recruiting
Beijing, Beijing Municipality · China
- Hui Liu
- The First Affiliated Hospital of Zhengzhou UniversityNot Yet Recruiting
Zhengzhou, Henan · China
- Zhongxing Jiang
- Xinqiao Hospital, Army Military Medical UniversityNot Yet Recruiting
Chongqing · China
- Xi Zhang
Terms used on this page · explanations by MedicalUpdates.ai
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Long-term follow-up
- Observation that continues for years after the study treatment, often required for gene and cell therapies.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- prospective cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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