Personalized Anticoagulant Therapy for Pulmonary Thromboembolism

NCT06341231 | Recruiting

• 1 other identifier: 202400248
• Study Type: observational
• Target: 4,700
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to 12 months after anticoagulant therapy

• 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

• Recurrent VTE

  Radiologically confirmed recurrent deep vein thrombosis, fatal or non-fatal pulmonary embolism

  From enrollment to 12 months after anticoagulant therapy

Secondary Outcomes (1)

• All-cause mortality

  From enrollment to 12 months after anticoagulant therapy

Study Arms (3)

Elderly patients with pulmonary thromboembolism

Pulmonary thromboembolism patients with renal insufficiency

Pulmonary thromboembolism patients with co-existing malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Special populations of PTE patients who are elderly, have renal insufficiency, or have concomitant malignancies.

You may qualify if:

• 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;
• Ecpected life expectancy longer than 3 months.
• Patients who understand and agree to participate in this study, sign the informed consent form, and adhere to regular follow-up visits.

You may not qualify if:

• 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;
• Patients currently participating in other clinical trials.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pengbo Deng, MD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengbo Deng, MD

CONTACT

+8613574888840; yogurt1015@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 2, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

CN (1)