Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism
Not yet recruiting
- Conditions
- Acute Pulmonary Embolism
- Interventions
- Device: Penumbra System
- Registration Number
- NCT06545864
- Lead Sponsor
- Assiut University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients who received systemic thrombolysis Streptokinase Injection patients have been diagnosed with acute intermediate-high pulmonary embolism received I.V. streptokinase if there are no contraindications. patients who underwent catheter-based intervention Penumbra System patients have been diagnosed with acute intermediate-high pulmonary embolism underwent catheter-based intervention including thrombus aspiration or catheter directed thrombolysis using Penumbra System
- Primary Outcome Measures
Name Time Method Change in blood pressure 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) Need for mechanical ventilation. during hospital stay (about 1 week) Change in heart rate during hospital stay (about 1 week) and one month after discharge Change of RV signs of PE by Transthoracic echocardiography during hospital stay (about 1 week) and one month after discharge Need for surgical intervention. during hospital stay (about 1 week) surgical embolectomy
Duration of hospital stay. during hospital stay (about 1 week)
- Secondary Outcome Measures
Name Time Method 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 Perforation of pulmonary artery during hospital stay (about 1 week) may occur 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
Trial Locations
- Locations (1)
Hospital University
🇪🇬Assiut, Egypt