Thrombolytic and Interventional Treatment of Pulmonary Embolism

NCT03886194 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-05-11

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

interventional treatment in pulmonary

Thrombolytic group: urokinase 20,000 units / kg body weight, 2 hours intravenous drip; or rtPA 50mg, 2 hours intravenous drip; and interventional treatment group: intracavitary catheter contact thrombolysis (urokinase 500,000 u 5 minute pulse Give), catheter thromboembolism, thrombus aspiration and mechanical thrombectomy.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Junbo Zhang · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-18
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886194 on ClinicalTrials.gov