Surgery in Pulmonary Embolisms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-02-01

Brief Summary

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Measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.

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Detailed Description

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* 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 of pulmonary embolism include malignancy, recent operation, hypercoagulability, and deep venous thrombosis (DVT). DVT is the most common risk factor.
* Acute pulmonary embolism is classified into massive or high risk (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)) and sub massive type or intermediate-high risk (characterized by evidence of adverse effects on the RV (dysfunction and strain), with mild hypotension, tachycardia, and 1 or more of the following: RV systolic hypo kinesis, RV dilatation by echocardiogram , elevated cardiac biomarkers (troponin I), elevated serum N-terminal pro brain natriuretic peptide, or electrocardiogram changes suggestive of RV strain.).
* Treatment options of acute massive and sub massive PE include systemic thrombolytic therapy, catheter directed thrombolysis (CDT) and surgical pulmonary embolectomy (SBE).
* The outcomes of the surgical treatment to the catheter-based treatment is still a topic of interest in management of acute pulmonary embolism.
* This study aims to measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients 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.

surgical pulmonary embolectomy

Intervention Type PROCEDURE

open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus

Patients with sub massive pulmonary embolism or intermediate -high risk

* 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 dysfunctions, 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.

surgical pulmonary embolectomy

Intervention Type PROCEDURE

open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus

Interventions

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surgical pulmonary embolectomy

open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No