Personalized Anticoagulant Therapy for Pulmonary Thromboembolism

NCT ID: NCT06341231

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Pulmonary Thromboembolisms; Anticoagulants; Increased

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Elderly patients with pulmonary thromboembolism

No interventions assigned to this group

Pulmonary thromboembolism patients with renal insufficiency

No interventions assigned to this group

Pulmonary thromboembolism patients with co-existing malignancy

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pengbo Deng, MD

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

Xiangya Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pengbo Deng, MD

Role: CONTACT

yogurt1015@163.com

+8613574888840

Facility Contacts

Juan Jiang, MD

Role: primary

juanjiang@csu.eud.cn

+8615388078713

Other Identifiers

202400248

Identifier Type: -

Identifier Source: org_study_id