Thrombolytic and Interventional Treatment of Pulmonary Embolism

Last updated: May 7, 2020
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Blood Clots

Occlusions

Treatment

N/A

Clinical Study ID

NCT03886194
XJTU1AF-CRF-2018-023
  • Ages 14-85
  • All Genders

Study Summary

Pulmonary embolism (PE) is a pulmonary vascular disease that seriously endangers human health. It has the characteristics of high morbidity, high mortality, high misdiagnosis rate and low detection rate. The mortality rate in March is about 10%. The high-risk and high-risk PE mortality rate is greater than 15%. Chronic thromboembolic pulmonary hypertension (CTEPH) is a serious sequelae after PE, with a poor prognosis and expensive treatment. Systemic thrombolysis is the preferred treatment for acute high-risk pulmonary embolism, which can reduce mortality, but the incidence of major bleeding is increased by 5 times and hemorrhagic stroke is increased by 10 times. Recent studies have concluded that interventional therapy is a viable approach with a high success rate, effective improvement of clinical outcomes, and minimization of major bleeding risks. However, there is no good prospective study of interventional therapy compared with systemic thrombolytic therapy. This study was enrolled in the diagnosis of high-risk and high-risk PE patients, randomized to the system of thrombolytic therapy or interventional therapy (including pulmonary artery catheter contact thrombolysis, catheter thrombectomy, thrombus aspiration and mechanical thrombectomy, etc.) Symptoms improved during surgery, right heart condition, mortality and complications, and were followed up to December to observe PE recurrence CETPH, survival and cardiopulmonary function. In order to provide new evidence for the treatment of fatal pulmonary embolism.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Han population with age greater than or equal to 14 years old and less than or equalto 85 years;

  • Signed informed consent;

  • confirmed initial acute pulmonary embolism, within 2 weeks of disease, pulmonaryembolism confirmed methods include: CTA/DSA/pulmonary ventilation Imaging: confirmedas at least 1 trunk pulmonary artery or proximal low lobe artery filling defect;

  • risk stratification for intermediate high-risk or high-risk pulmonary embolism: 2014ESC stratified definition of high-risk and high-risk: high-risk PE: hemodynamicsObstruction, systolic blood pressure <90mmHg, greater than 15 minutes; medium and highrisk PE: right ventricular dysfunction imaging findings (RV / LV ≥ 0.9) and myocardialdamage indicators positive (TNT > 0.1 ng / ml);

  • blood flow at admission The kinetics are stable.

Exclusion

Exclusion Criteria:

  • patients with mental illness can not cooperate with the completion of the study; -CTPA / DSA contraindications patients;

  • any contraindications listed in the instructions for treatment of the drug involved inthe study;

  • diseases associated with coagulopathy leading to the risk of clinically relevantbleeding;

  • There are active bleeding or high risk of bleeding in patients with anticoagulantthrombolysis contraindications;

  • creatinine clearance rate <30 mL / min;

  • life expectancy ≤ 6 months;

  • childbearing age or pregnancy, lactation period without appropriate contraceptivemeasures Subjects;

  • participated in any other drug or medical device study within 30 days prior torandomization;

  • cases that the investigator considered unsuitable for participation in the trial.

Study Design

Total Participants: 40
Study Start date:
August 18, 2019
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

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