Hydro-mechanical Defragmentation of Pulmonary Embolism

Not Applicable

Completed

• Conditions: Pulmonary Embolism
• Interventions: Procedure: catheter directed hydro-mechanical fragmentation of pulmonary embolism

• Registration Number: NCT04099186
• Lead Sponsor: Assiut University

Brief Summary

Evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy

Detailed Description

In 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 injection of 200 ml saline at high pressure using power injector can be used as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Primary Completion: 2020-11-01
• Study Completion: 2021-01-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 cannot receive fibrinolysis
• Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis)

Exclusion Criteria

• Patients with echocardiographically confirmed right sided thrombi.
• Patients with low-risk pulmonary embolism or intermediate-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
• Anaphylactic reaction to contrast media.
• Acute renal failure or severe chronic non-dialysis dependent kidney disease.
• Uncooperative patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydro-mechanical pulmonary embolism fragmentation	catheter directed hydro-mechanical fragmentation of pulmonary embolism	Those patients will undergo catheter directed fragmentation followed by injection of 100 ml of heparinized saline via power injector

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days	measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis

Secondary Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt