Personalized Anticoagulant Therapy for Pulmonary Thromboembolism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXiangya Hospital of Central South University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old;
Adult patients with objectively diagnosed pulmonary thromboembolism (PTE) (with or without concomitant deep vein thrombosis);
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);
Patients who have not started anticoagulant therapy before enrollment and are planned for anticoagulant treatment after evaluation by the attending physician;
Disqualifiers
Moderate or severe liver dysfunction (Child-Pugh class B or C);
Spontaneous bleeding tendency, such as coagulation disorders or thrombocytopenia (PLT<20×10^9/L);
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;
High-risk pulmonary embolism requiring thrombolysis;
Trial population
Special populations of PTE patients who are elderly, have renal insufficiency, or have concomitant malignancies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
4,700 Participants
are grouped into 3 trial groupsGroup A: Elderly patients with pulmonary thromboembolism
Group B: Pulmonary thromboembolism patients with renal insufficiency
Group C: Pulmonary thromboembolism patients with co-existing malignancy
Trial outcomes
Primary outcomes
1
Major bleeding
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.
Time frame
From enrollment to 12 months after anticoagulant therapy2
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
Time frame
From enrollment to 12 months after anticoagulant therapy3
Recurrent VTE
Radiologically confirmed recurrent deep vein thrombosis, fatal or non-fatal pulmonary embolism
Time frame
From enrollment to 12 months after anticoagulant therapySecondary outcomes
1
All-cause mortality
All-cause mortality
Time frame
From enrollment to 12 months after anticoagulant therapySponsors and contacts
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Source ClinicalTrials.gov