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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Monocentric, randomized, open-label, controlled, clinical, non-inferiority trial.|
|Masking:||None (Open Label)|
|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|
|Active Comparator: surgical pulmonary embolectomy||
Procedure: surgical pulmonary embolectomy
|Active Comparator: catheter-directed thrombolysis||
Combination Product: catheter-directed thrombolysis
- Difference in RV/LV ratio by contrast-enhanced chest computed tomography [ Time Frame: 48-72 hours after surgical embolectomy or catheter therapy ]
- Difference in pulmonary occlusion score by contrast-enhanced chest computed tomography [ Time Frame: 48-72 hours after surgical embolectomy or catheter therapy ]
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
|Contact: Lars Englberger, Proffirstname.lastname@example.org|
|University Hospital Bern||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Lars Englberger, Prof +41-31-6322111 email@example.com|
|Principal Investigator:||Lars Englberger, Prof.||University of Bern|