Personalized Anticoagulant Therapy for Pulmonary Thromboembolism

Recruiting

• Conditions: Pulmonary Thromboembolisms; Anticoagulants; Increased

• Registration Number: NCT06341231
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-31
• Last Update Submitted: 2024-03-31
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4700

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically relevant non-major bleeding	From enrollment to 12 months after anticoagulant therapy	Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: i requiring medical intervention by a healthcare professional ii leading to hospitalization or increased level of care iii prompting a face to face (i.e., not just a telephone or electronic communication) evaluation
Recurrent VTE	From enrollment to 12 months after anticoagulant therapy	Radiologically confirmed recurrent deep vein thrombosis, fatal or non-fatal pulmonary embolism
Major bleeding	From enrollment to 12 months after anticoagulant therapy	1. Fatal bleeding, and/or; 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or; 3. Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	From enrollment to 12 months after anticoagulant therapy	All-cause mortality

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China