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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06341231
Other study ID # 202400248
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date December 31, 2027

Study information

Verified date March 2024
Source Xiangya Hospital of Central South University
Contact Pengbo Deng, MD
Phone +8613574888840
Email yogurt1015@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4700
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
China Xiangya Hospital Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major bleeding Fatal bleeding, and/or
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
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.
From enrollment to 12 months after anticoagulant therapy
Primary Clinically relevant non-major bleeding 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
From enrollment to 12 months after anticoagulant therapy
Primary Recurrent VTE Radiologically confirmed recurrent deep vein thrombosis, fatal or non-fatal pulmonary embolism From enrollment to 12 months after anticoagulant therapy
Secondary All-cause mortality All-cause mortality From enrollment to 12 months after anticoagulant therapy
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