Surgery in Pulmonary Embolisms

September 30, 2023 updated by: Mohamed Emad Kamel, Assiut University

Early Outcomes of Surgery in Patients With Massive and Sub Massive Pulmonary Embolism: ( a Single Center Experience)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with massive and sub massive pulmonary embolism entering Assiut university hospital from October 2022 to November 2025 will be taken to be treated by surgical pulmonary embolectomy.

patients will be divided according to type pulmonary embolism into two groups: massive pulmonary embolism group and sub massive pulmonary embolism group all of them will have the same inclusion and exclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: surgical pulmonary embolectomy
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.
Procedure: surgical pulmonary embolectomy
open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: baseline
number of patients died
baseline
NYHA Functional Classification.
Time Frame: baseline

I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.

III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.

IV Symptoms of heart failure at rest. Any physical activity causes further discomfort.
baseline
right ventricular dimension
Time Frame: baseline
dimensions of right ventricle in centimeter by echocardiography
baseline
left ventricular ejection fraction (EF %)
Time Frame: baseline
left ventricular ejection fraction (EF ) percentage by echocardiography
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital stay days
Time Frame: baseline
number of days the patient stayed at hospital after the surgery
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed EL-Minshawy, professor, professor of cardiothoracic surgery surgery department
  • Study Director: Sameh Abdelrahman, professor, professor at cardiothoracic surgery department
  • Study Director: Alaa Salah, lecturer, lecturer at pulmonary disease department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 30, 2023

First Submitted That Met QC Criteria

September 30, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • surgery in pulmonary embolisms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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