Personalized anticoagulant therapy for pulmonary thromboembolism

Personalized Anticoagulant Therapy for Pulmonary Thromboembolism in Specific Populations With Older Age, Renal Insufficiency or Co-existing Malignancy

This study is trying to see how different factors affect the safety and effectiveness of blood-thinning treatments for older adults and people with kidney issues or cancer who have pulmonary thromboembolism.

Quick facts

• Study type: Observational
• Enrollment: 4700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06341231 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the factors affecting the efficacy and safety of anticoagulant therapy in patients with pulmonary thromboembolism, particularly focusing on older adults, those with renal insufficiency, and individuals with active malignancies. The study will analyze real-world data to identify influencing factors and develop a predictive model using machine learning to forecast bleeding events and recurrence of venous thromboembolism. Participants will receive standard diagnostic and therapeutic measures as per clinical guidelines, including anticoagulant treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed pulmonary thromboembolism, particularly those who are elderly, have renal impairment, or are undergoing treatment for malignancies.

Not a fit: Patients with moderate to severe liver dysfunction or those with a spontaneous bleeding tendency may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective anticoagulant therapies for vulnerable patient populations.

How similar studies have performed: While similar studies have explored anticoagulant therapy, this approach focusing on specific vulnerable populations and utilizing machine learning for predictive modeling is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Adult patients with objectively diagnosed pulmonary thromboembolism (PTE) (with or without concomitant deep vein thrombosis);
3. 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);
4. Patients who have not started anticoagulant therapy before enrollment and are planned for anticoagulant treatment after evaluation by the attending physician;
5. Ecpected life expectancy longer than 3 months.
6. Patients who understand and agree to participate in this study, sign the informed consent form, and adhere to regular follow-up visits.

Exclusion Criteria:

1. Moderate or severe liver dysfunction (Child-Pugh class B or C);
2. Spontaneous bleeding tendency, such as coagulation disorders or thrombocytopenia (PLT\<20×10\^9/L);
3. 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;
4. High-risk pulmonary embolism requiring thrombolysis;
5. Patients currently participating in other clinical trials.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Pengbo Deng, MD — Xiangya Hospital of Central South University
• Study coordinator: Pengbo Deng, MD

Conditions Pulmonary Thromboembolisms; Anticoagulants; Increased