Catheter Directed Interventions in Pulmonary Embolism

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03595085

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism	Procedure: catheter directed fragmentation and thrombolysis Drug: Streptokinase	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

30-day mortality [30 days]
measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis

Secondary Outcome Measures

Changes in blood pressure [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
oxygen saturation [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
changes in right ventricular dysfunction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

heba ahmed hamed, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03595085

Other Study ID Numbers:

CTPE

First Posted:

Jul 23, 2018

Last Update Posted:

Jul 24, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Embolism

Embolism

Streptokinase

Study Results

No Results Posted as of Jul 24, 2018