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Thrombolytic and Interventional Treatment of Pulmonary Embolism

Primary Purpose

Pulmonary Embolism

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

interventional treatment in pulmonary

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

14 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Han population with age greater than or equal to 14 years old and less than or equal to 85 years;
Signed informed consent;
confirmed initial acute pulmonary embolism, within 2 weeks of disease, pulmonary embolism confirmed methods include: CTA/DSA/pulmonary ventilation Imaging: confirmed as 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: hemodynamics Obstruction, systolic blood pressure <90mmHg, greater than 15 minutes; medium and high risk PE: right ventricular dysfunction imaging findings (RV / LV ≥ 0.9) and myocardial damage indicators positive (TNT > 0.1 ng / ml);
blood flow at admission The kinetics are stable.

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 in the study;
diseases associated with coagulopathy leading to the risk of clinically relevant bleeding;
There are active bleeding or high risk of bleeding in patients with anticoagulant thrombolysis contraindications;
creatinine clearance rate <30 mL / min;
life expectancy ≤ 6 months;
childbearing age or pregnancy, lactation period without appropriate contraceptive measures Subjects;
participated in any other drug or medical device study within 30 days prior to randomization;
cases that the investigator considered unsuitable for participation in the trial.

Sites / Locations

The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Thrombolytic group

Interventional treatment group

Arm Description

Thrombolytic group: urokinase 20,000 units / kg body weight, 2 hours intravenous drip; or rtPA 50mg, 2 hours intravenous drip

Interventional treatment group: intracavitary catheter contact thrombolysis (urokinase 500,000 u 5 minute pulse Give), catheter thromboembolism, thrombus aspiration and mechanical thrombectomy.

Outcomes

Primary Outcome Measures

Right heart load

RV/LV (thoracic enhanced CT/cardiac ultrasound),pulmonary artery pressure (catheter/cardiac ultrasound),troponin T, NT-proBNP, 6-minute walk test

death within 30 days

number of deaths

Secondary Outcome Measures

Full Information

NCT ID

NCT03886194

First Posted

March 20, 2019

Last Updated

May 7, 2020

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT03886194

Brief Title

Thrombolytic and Interventional Treatment of Pulmonary Embolism

Official Title

Comparative Study of Interventional and Systemic Thrombolysis in Patients With High-risk and High-risk Pulmonary Embolism

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 18, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thrombolytic group

Arm Type

Active Comparator

Arm Description

Thrombolytic group: urokinase 20,000 units / kg body weight, 2 hours intravenous drip; or rtPA 50mg, 2 hours intravenous drip

Arm Title

Interventional treatment group

Arm Type

Experimental

Arm Description

Interventional treatment group: intracavitary catheter contact thrombolysis (urokinase 500,000 u 5 minute pulse Give), catheter thromboembolism, thrombus aspiration and mechanical thrombectomy.

Intervention Type

Procedure

Intervention Name(s)

interventional treatment in pulmonary

Intervention Description

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.

Primary Outcome Measure Information:

Title

Right heart load

Description

RV/LV (thoracic enhanced CT/cardiac ultrasound),pulmonary artery pressure (catheter/cardiac ultrasound),troponin T, NT-proBNP, 6-minute walk test

Time Frame

30 days

Title

death within 30 days

Description

number of deaths

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Han population with age greater than or equal to 14 years old and less than or equal to 85 years; Signed informed consent; confirmed initial acute pulmonary embolism, within 2 weeks of disease, pulmonary embolism confirmed methods include: CTA/DSA/pulmonary ventilation Imaging: confirmed as 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: hemodynamics Obstruction, systolic blood pressure <90mmHg, greater than 15 minutes; medium and high risk PE: right ventricular dysfunction imaging findings (RV / LV ≥ 0.9) and myocardial damage indicators positive (TNT > 0.1 ng / ml); blood flow at admission The kinetics are stable. 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 in the study; diseases associated with coagulopathy leading to the risk of clinically relevant bleeding; There are active bleeding or high risk of bleeding in patients with anticoagulant thrombolysis contraindications; creatinine clearance rate <30 mL / min; life expectancy ≤ 6 months; childbearing age or pregnancy, lactation period without appropriate contraceptive measures Subjects; participated in any other drug or medical device study within 30 days prior to randomization; cases that the investigator considered unsuitable for participation in the trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junbo Zhang

Phone

0086-18991232665

zhangjunbo@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junbo Zhang

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Study Chair

Facility Information:

Facility Name

The First Affiliated Hospital of Xi'an Jiaotong University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

junbo zhang

Phone

18991232665

zhangjunbo@126.com

12. IPD Sharing Statement

Plan to Share IPD

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Thrombolytic and Interventional Treatment of Pulmonary Embolism

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