Acute Pulmonary Embolism, Pulmonary Embolism
Conditions
Keywords
Acute Pulmonary Embolism
Brief summary
To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA
Detailed 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.
Interventions
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of RV to LV Diameter Ratio | baseline and 30days after baseline | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of death | 30days |
| Rate of major Bleeding | 30days |
| Pulmonary embolism recurrence | 30days |
Countries
China
Outcome results
None listed