Hydro-mechanical Defragmentation of Pulmonary Embolism

Assiut University

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Procedure: catheter directed hydro-mechanical fragmentation of pulmonary embolism

Study type: Interventional

Funder types: Other

Identifiers

NCT04099186

HMDPE

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

hydro-mechanical pulmonary embolism fragmentation

Experimental group

Description:

Those patients will undergo catheter directed fragmentation followed by injection of 100 ml of heparinized saline via power injector

Treatment:

Procedure: catheter directed hydro-mechanical fragmentation of pulmonary embolism

thrombolytic treated arm

No Intervention group

Description:

patients with high risk and intermediate high risk PE who received thrombolysis as only treatment modality