Status:
NOT_YET_RECRUITING
Surgery in Pulmonary Embolisms
Lead Sponsor:
Assiut University
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
17+ years
Brief Summary
Measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.
Detailed Description
* Pulmonary embolism (PE) is one of the most important causes of mortality in cardiovascular diseases. It represents the third cause of mortality after myocardial infarction and stroke. * Risk factors...
Eligibility Criteria
Inclusion
- Patient with massive pulmonary embolism or high-risk patients characterized by :
- Evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure\<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate\<40 bpm).
- CT pulmonary angiography demonstrating a thrombus which occludes greater than 50% of the pulmonary artery (PA) cross-sectional area or occludes two or more lobar arteries.
- Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of \>0.9 on four chamber view.
- Elevated cardiac troponin T and I above normal limits.
- Patients with sub massive pulmonary embolism or intermediate -high risk characterized by:
- Systolic blood pressure \>90 mmHg and tachycardia (heart rate \> 100 bpm).
- CT pulmonary angiography shows that 30% to 50% of the pulmonary vasculature is occluded.
- Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of \>0.9 on four chamber view.
- Elevated cardiac troponin T and I above normal limits
Exclusion
- Patients less than 18 years of age.
- Low risk acute pulmonary embolism (less than 30% occlusion of pulmonary vasculature by CT pulmonary angiography, no signs of Rt ventricular systolic dysfunction, RV dilation or a RV/left ventricular (LV) diameter ratio of \>0.9 on four chamber view by Echocardiography.
- Acute on top of chronic pulmonary embolism.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06070129
Start Date
November 1 2023
End Date
February 1 2026
Last Update
October 6 2023
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