NCT06341231Recruiting
Personalized Anticoagulant Therapy for Pulmonary Thromboembolism
Personalized Anticoagulant Therapy for Pulmonary Thromboembolism in Specific Populations With Older Age, Renal Insufficiency or Co-existing Malignancy
Source: ClinicalTrials.gov · Last updated 2 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are: * To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors). * Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4700 (estimated)
- First submitted
- 12 Mar 2024
- Start date
- 1 Feb 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Xiangya Hospital of Central South University
- NCT number
- NCT06341231
What you commit to
- Study type: Observational
- Planned participants: 4700
- From 1 Feb 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindications to anticoagulant drugs, including allergy to anticoagulants, clinically significant active bleeding, significant risk of major bleeding due to lesions or conditions, significantly abnormal coagulation function, liver disease with clinically relevant bleeding risk, thrombocytopenia, etc., as determined by the attending physician;
Lab values
- Spontaneous bleeding tendency, such as coagulation disorders or thrombocytopenia (PLT\<20×10\^9/L);
Other
- Moderate or severe liver dysfunction (Child-Pugh class B or C);
- High-risk pulmonary embolism requiring thrombolysis;
- Patients currently participating in other clinical trials.
Who the study is looking for
- Age ≥ 18 years old;
- Adult patients with objectively diagnosed pulmonary thromboembolism (PTE) (with or without concomitant deep vein thrombosis);
- Specific populations meeting any of the following criteria: elderly patients (≥75 years old); patients with impaired kidney function (creatinine clearance estimated by the Cockcroft-Gault formula, CrCl \< 60ml/min); patients with active malignancies (under treatment or with unrecovered malignancies);
- Patients who have not started anticoagulant therapy before enrollment and are planned for anticoagulant treatment after evaluation by the attending physician;
- Ecpected life expectancy longer than 3 months.
- Patients who understand and agree to participate in this study, sign the informed consent form, and adhere to regular follow-up visits.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.