Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03966079
Other study ID # BeijingTCGH
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2017
Est. completion date January 31, 2020

Study information

Verified date November 2020
Source Beijing Tsinghua Chang Gung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA


Description:

The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - CT evidence of proximal PE - Age = 18 years - Pulmonary embolism symptom duration =14 days - Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter = 0.9 on contrast-enhanced chest CT) Exclusion Criteria: - Age <18 years - PE symptom duration >14 days - Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year - Recent (within one month) or active bleeding from a major organ - Pregnancy - Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease - Administration of thrombolytic agents within the previous 3 days - Life expectancy < 30 days - Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated - Inability to follow protocol requirements

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
recombinant tissue plasminogen activator
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter

Locations

Country Name City State
China Beijing Tsinghua Chang Gung Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of RV to LV Diameter Ratio Determine whether single-dose rtpa catheter-directed thrombolysis decrease the ratio of right ventricular (RV)-to-left ventricular (LV) diameter within 1month in patients with right ventricular dysfunction baseline and 30days after baseline
Secondary Rate of death 30days
Secondary Rate of major Bleeding 30days
Secondary Pulmonary embolism recurrence 30days
See also
  Status Clinical Trial Phase
Recruiting NCT05050617 - Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Completed NCT03915925 - Short-term Clinical Deterioration After Acute Pulmonary Embolism
Completed NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Recruiting NCT05171075 - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE Phase 3
Completed NCT04454554 - Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
Completed NCT03173066 - Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography Phase 1
Terminated NCT03002467 - Impact Analysis of Prognostic Stratification for Pulmonary Embolism N/A
Completed NCT02611115 - Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography. N/A
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Completed NCT01975090 - The SENTRY Clinical Study N/A
Not yet recruiting NCT01357941 - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) N/A
Completed NCT01326507 - Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism N/A
Completed NCT00771303 - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed NCT00780767 - Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism Phase 2
Completed NCT00720915 - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months N/A
Completed NCT00773448 - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism N/A
Completed NCT02476526 - Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease Phase 4
Completed NCT00244725 - Odiparcil For The Prevention Of Venous Thromboembolism Phase 2