Clinical trial NCT04099186: Hydro-mechanical Defragmentation of Pulmonary Embolism
Official title: Evaluation of Safety and Efficacy of Hydro-mechanical Defragmentation of High Risk Pulmonary Embolism With Contraindications to Thrombolytic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non randomized case control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: oxygen saturation
timeFrame: 24 hours
measure: Changes in blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
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citation: Hassan AKM, Ahmed H, Ahmed Y, Elfadl AA, Omar A. Efficacy and safety of hydro-mechanical defragmentation in intermediate- and high-risk pulmonary embolism. Egypt Heart J. 2021 Sep 25;73(1):84. doi: 10.1186/s43044-021-00204-2.