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Surgical Pulmonary Embolectomy Versus Catheter-directed Thrombolysis in the Treatment of Pulmonary Embolism: A Non-inferiority Study (Lungembolism)

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ClinicalTrials.gov Identifier: NCT03218410
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
University of Bern
Schweizerische Herzstiftung
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

Acute pulmonary embolism (PE) is a serious and potentially lethal condition. The clinical spectrum of PE spans from asymptomatic PE to patients with severe hemodynamic compromise. The main determinant of outcome is right ventricular dysfunction caused by the abrupt rise in pulmonary vascular resistance. Patients with hemodynamic compromise are at highest risk of mortality (>15%). Hemodynamic stable patients with imaging and biomarker evidence of right ventricular (RV)- dysfunction are at intermediate-high risk of mortality (3-15%). According to the European Society of Cardiology (ESC) guidelines reperfusion therapy options for patients at high risk and at intermediate-high risk include systemic thrombolysis, catheter-directed therapy or surgical embolectomy.

The University Hospital of Bern is the only tertiary care hospital in Switzerland that has established an interdisciplinary pulmonary embolism response team (PERT since 2010) and has gained expertise in both catheter-directed thrombolysis and surgical embolectomy. Since the introduction of PERT, systemic thrombolysis was no longer performed in Bern due to the high risk of intracranial hemorrhage. Favorable clinical outcomes of the patients managed in Bern have been published for both catheter-directed therapy and surgical embolectomy.

To date, no study has ever compared catheter-directed thrombolysis versus surgical pulmonary embolectomy in the treatment of high and intermediate-high risk PE patients.


Condition or disease Intervention/treatment Phase
Acute Pulmonary Embolism (PE) Procedure: surgical pulmonary embolectomy Combination Product: catheter-directed thrombolysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Monocentric, randomized, open-label, controlled, clinical, non-inferiority trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Pulmonary Embolectomy Versus Catheter-directed Thrombolysis in the Treatment of Pulmonary Embolism: A Randomized Phase II Non-inferiority Study
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: surgical pulmonary embolectomy Procedure: surgical pulmonary embolectomy
Active Comparator: catheter-directed thrombolysis Combination Product: catheter-directed thrombolysis



Primary Outcome Measures :
  1. Difference in RV/LV ratio by contrast-enhanced chest computed tomography [ Time Frame: 48-72 hours after surgical embolectomy or catheter therapy ]

Secondary Outcome Measures :
  1. Difference in pulmonary occlusion score by contrast-enhanced chest computed tomography [ Time Frame: 48-72 hours after surgical embolectomy or catheter therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute symptomatic PE with thrombus located in the pulmonary main trunk or the left and/or right main pulmonary artery
  2. High-risk PE defined as PE with sustained systemic arterial hypotension (systolic pressure <90mmHg), cardiogenic shock, or the ongoing need for catecholamine therapy

    OR

    Intermediate-high risk PE: Imaging evidence of RV-Dilatation (right-to-left ventricular diameter ratio >1.0 on echocardiography or chest computed tomography) and biomarker evidence of RV dysfunction (positive Troponin T or I Test).

  3. The eligibility for both procedures must be established by the PERT team
  4. Signed Informed consent (by subject or legal representative) -

Exclusion Criteria:

  1. Age less than 18 years or greater than 80 years.
  2. Symptom duration > 14 days suggesting acute-on-chronic pulmonary embolism.
  3. Known chronic thromboembolic pulmonary hypertension (CTEPH)
  4. Suspected chronic thromboembolic pulmonary hypertension (CTEPH) including RV hypertrophy (RV free wall >5 mm on echocardiography), severe pulmonary hypertension (systolic pulmonary artery pressure > 80 mmHg on echocardiography), or CT findings suggestive of CTEPH including intraluminal webs, bands, strictures, or eccentric filling defects adjacent to the wall of the pulmonary arteries
  5. Decompensated cardiogenic shock defined as recent (<48 hours) cardiopulmonary resuscitation therapy or worsening hemodynamic status despite extended fluid and catecholamine support
  6. Inability to tolerate catheter procedure or surgical embolectomy due to severe comorbidities.
  7. Allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
  8. Known significant bleeding risk, or known coagulation disorder (including vitamin K antagonists with INR > 2.0 and platelet count < 100 000/mm3)
  9. Severe renal impairment (estimated GFR < 30 ml/min).
  10. Active bleeding: recent (< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
  11. Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
  12. History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
  13. Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
  14. Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test in women of childbearing age)
  15. Recent (< 1 month) systemic thrombolysis.
  16. Life expectancy < 6 months or chronic non-ambulatory status.
  17. Participating in any other investigational drug or device study or previous enrollment in this study
  18. Inability to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
  19. Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.

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 ClinicalTrials.gov identifier (NCT number): NCT03218410


Contacts
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Contact: Lars Englberger, Prof +41-31-63222375 lars.englberger@insel.ch

Locations
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Switzerland
University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Lars Englberger, Prof    +41-31-6322111    lars.englberger@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Schweizerische Herzstiftung
Investigators
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Principal Investigator: Lars Englberger, Prof. University of Bern
Publications of Results:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03218410    
Other Study ID Numbers: 183/15
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: March 5, 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
Keywords provided by University Hospital Inselspital, Berne:
surgical embolectomy
catheter-directed therapy
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases