Personalized Anticoagulant Therapy for Pulmonary Thromboembolism

Last updated: March 31, 2024
Sponsor: Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Embolism

Venous Thromboembolism

Lung Injury

Treatment

N/A

Clinical Study ID

NCT06341231
202400248
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old;
  2. Adult patients with objectively diagnosed pulmonary thromboembolism (PTE) (with orwithout concomitant deep vein thrombosis);
  3. Specific populations meeting any of the following criteria: elderly patients (≥75years old); patients with impaired kidney function (creatinine clearance estimated bythe 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 plannedfor 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 informedconsent form, and adhere to regular follow-up visits.

Exclusion

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 tolesions or conditions, significantly abnormal coagulation function, liver disease withclinically relevant bleeding risk, thrombocytopenia, etc., as determined by theattending physician;
  4. High-risk pulmonary embolism requiring thrombolysis;
  5. Patients currently participating in other clinical trials.

Study Design

Total Participants: 4700
Study Start date:
February 01, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Xiangya Hospital

    Changsha, Hunan 410008
    China

    Active - Recruiting

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