Catheter Directed Interventions in Pulmonary Embolism

July 21, 2018 updated by: heba ahmed hamed, Assiut University

Safety and Efficacy of Catheter Directed Interventions in Acute High Risk Pulmonary Embolism

Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acute pulmonary embolism is common, but its presentation highly varies ranging from asymptomatic to massive pulmonary embolism. Massive pulmonary embolism is a common life-threatening condition and represents the most serious manifestation among venous thromboembolic disease.

Acute pulmonary embolism is considered the third most common cause of death among hospitalized patients . The mortality rate can exceed 58% in patients with acute pulmonary embolism presenting with haemodynamic instability , mostly occur within 1 hour of presentation.

In patients with high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk.

The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited.

Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by local thrombolytic therapy is accepted as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow. Several reports have shown that catheter-directed therapy is a safe and effective treatment for acute PE to restore pulmonary flow and decreasing Pulmonary artery systolic pressure , However, current knowledge on efficacy and safety of catheter-directed therapy in management of intermediate high risk pulmonary embolism is limited.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with angiographically confirmed acute high risk pulmonary embolism with shock index >1.
  • Pulmonary arterial occlusion with >50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure >25 mmHg)
  • Patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
  • Patients with high risk pulmonary embolism who cannot receive fibrinolysis
  • Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis)

Exclusion Criteria:

  • Patients with echocardiographically confirmed right sided thrombi.
  • Patients with low-risk pulmonary embolism or intermediater-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
  • Acute gastrointestinal bleeding.
  • Anticoagulation with international normalized ratio >1.8 or severe coagulopathy.
  • Anaphylactic reaction to contrast media.
  • Acute stroke.
  • Acute renal failure or severe chronic non-dialysis dependent kidney disease.
  • Uncooperative patient

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: catheter directed interventions
Those patients will undergo catheter directed fragmentation followed by local thrombolysis using streptokinase
Procedure: catheter directed fragmentation and thrombolysis
A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours
Active Comparator: systemic thrombolysis
Those patients will receive systemic streptokinase
Drug: Streptokinase
intravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days
measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood pressure
Time Frame: 24 hours
systolic and diastolic blood pressure will be measured at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
24 hours
oxygen saturation
Time Frame: 24 hours
oxygen saturation will be measured by arterial blood gases analysis at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
24 hours
changes in right ventricular dysfunction
Time Frame: 24 hours
right ventricular dysfunction will be assessed by echocardiography and Mean pulmonary artery systolic pressure will be estimated by transthoracic echocardiography at first admission and 24 hours after catheter-directed intervention
24 hours

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 21, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTPE

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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