Acute Pulmonary Embolism
Conditions
Keywords
intermediate-high, acute pulmonary embolism, systemic thrombolysis, catheter- directed management
Brief summary
To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
Interventions
DRUGStreptokinase Injection
250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours
DEVICEPenumbra System
which comprised of several devices: * RED Reperfusion Catheters * Penumbra JET Reperfusion Catheters * ACE Reperfusion Catheters * MAX Reperfusion Catheters * 3D Revascularization Device * Penumbra ENGINE Aspiration Source * Penumbra ENGINE Canister * Aspiration Tubing
Sponsors
Assiut University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with acute intermediate-high pulmonary embolism
Exclusion criteria
* Patients less than 18 years of age. * Low risk, intermediate low risk, acute pulmonary embolism * patients with RV masses will be excluded. * Patient refusal of treatment strategy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay. | during hospital stay (about 1 week) | — |
| Change of RV signs of PE by Transthoracic echocardiography | during hospital stay (about 1 week) and one month after discharge | — |
| Need for mechanical ventilation. | during hospital stay (about 1 week) | — |
| Need for surgical intervention. | during hospital stay (about 1 week) | surgical embolectomy |
| Change in blood pressure | during hospital stay (about 1 week) and one month after discharge | — |
| Change in heart rate | during hospital stay (about 1 week) and one month after discharge | — |
| Change in respiratory rate | during hospital stay (about 1 week) and one month after discharge | — |
| Change of O2 saturation. | during hospital stay (about 1 week) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of pericardial effusion | during hospital stay (about 1 week) and one month after discharge | due to: infection cardiac perforation during catheter directed interventions |
| incidence of Major bleeding | during hospital stay (about 1 week) and one month after discharge | that requires blood transfusions or urgent intervention |
| incidence of Perforation of pulmonary artery | during hospital stay (about 1 week) | may occur during catheter directed interventions |
Countries
Egypt
Contacts
Primary Contactmariam J william
Outcome results
None listed