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Hydro-mechanical Defragmentation of Pulmonary Embolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04099186
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : March 10, 2020
Information provided by (Responsible Party):
Ayman Khairy Mohamed Hassan, Assiut University

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

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Procedure: catheter directed hydro-mechanical fragmentation of pulmonary embolism Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Hydro-mechanical Defragmentation of High Risk Pulmonary Embolism With Contraindications to Thrombolytic Therapy
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: hydro-mechanical pulmonary embolism fragmentation
Those patients will undergo catheter directed fragmentation followed by injection of 200 ml saline via power injector
Procedure: catheter directed hydro-mechanical fragmentation of pulmonary embolism
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 , then 200 ml saline will be injected via power injector to aid fragmentation of thrombus

Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
    measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04099186

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Contact: Heba A Hamed, master 01110022144

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Assiut University Recruiting
Assiut, Egypt, 71515
Contact: Heba A Hamed    1110022144   
Sponsors and Collaborators
Assiut University

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Responsible Party: Ayman Khairy Mohamed Hassan, assisstant professor, Assiut University Identifier: NCT04099186    
Other Study ID Numbers: HMDPE
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases