Actively Recruiting
Personalized Anticoagulant Therapy for Pulmonary Thromboembolism in Specific Populations with Older Age, Kidney Problems, or Cancer
Led by Xiangya Hospital of Central South University · Updated on 2024-04-02
4700
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are examining how anticoagulant therapy works for people with pulmonary thromboembolism (PTE), especially focusing on older adults, those with kidney problems, or cancer. The study aims to find factors that affect the treatment's safety and success, and to develop machine-learning models to predict bleeding events and recurrence of blood clots in these special groups. Participants will receive care for PTE following clinical guidelines, including anticoagulant treatment decided by their doctors. Some participants will have blood samples taken at the start and three months after starting therapy to support research. This is an observational study, so treatments are not assigned by the researchers but recorded as they happen in real life. Throughout the study, participants will be monitored for any major or clinically relevant bleeding and for blood clot recurrence over 12 months after starting treatment. Researchers will also track overall survival during this time. Participants must agree to regular follow-ups and provide consent, with the total observation lasting up to one year after treatment begins.
CONDITIONS
Brief Title
Personalized Anticoagulant Therapy for Pulmonary Thromboembolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Adult patients with confirmed pulmonary thromboembolism, with or without deep vein thrombosis
- Patients who are either 75 years or older, have impaired kidney function (creatinine clearance under 60 ml/min), or have active cancer
- Patients who have not started anticoagulant therapy before enrollment and are planned to begin treatment
- Expected life expectancy longer than 3 months
- Patients who understand and agree to participate, sign consent, and comply with follow-up visits
You will not qualify if you...
- Moderate or severe liver dysfunction (Child-Pugh class B or C)
- Spontaneous bleeding tendency such as coagulation disorders or very low platelet count (PLT <20×10^9/L)
- Contraindications to anticoagulant drugs including allergy, active significant bleeding, or high bleeding risk conditions
- High-risk pulmonary embolism requiring clot-dissolving treatment
- Current participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months after anticoagulant therapy begins
Participants who undergo routine care for pulmonary thromboembolism are observed to collect data on bleeding events, recurrent venous thromboembolism, and mortality over time.
Regular visits as part of routine care
Trial Site Locations
Total: 1 location
1
Xiangya Hospital
Changsha, Hunan, China, 410008
Actively Recruiting
Research Team
P
Pengbo Deng, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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