Surgical Pulmonary Embolectomy Versus Catheter-directed Thrombolysis in the Treatment of Pulmonar… (NCT03218410) | Clinical Trial Compass
CompletedNot Applicable
Surgical Pulmonary Embolectomy Versus Catheter-directed Thrombolysis in the Treatment of Pulmonary Embolism: A Non-inferiority Study
Switzerland60 participantsStarted 2015-10-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Acute symptomatic PE with thrombus located in the pulmonary main trunk or the left and/or right main pulmonary artery
✓. High-risk PE defined as PE with sustained systemic arterial hypotension (systolic pressure \<90mmHg), cardiogenic shock, or the ongoing need for catecholamine therapy
✓. The eligibility for both procedures must be established by the PERT team
✓. Signed Informed consent (by subject or legal representative) -
Exclusion criteria
✕. Age less than 18 years or greater than 80 years.
✕. Symptom duration \> 14 days suggesting acute-on-chronic pulmonary embolism.
✕. Known chronic thromboembolic pulmonary hypertension (CTEPH)
✕. 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
What they're measuring
1
Difference in RV/LV ratio by contrast-enhanced chest computed tomography
Timeframe: 48-72 hours after surgical embolectomy or catheter therapy
✕. Decompensated cardiogenic shock defined as recent (\<48 hours) cardiopulmonary resuscitation therapy or worsening hemodynamic status despite extended fluid and catecholamine support
✕. Inability to tolerate catheter procedure or surgical embolectomy due to severe comorbidities.
✕. 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.
✕. Known significant bleeding risk, or known coagulation disorder (including vitamin K antagonists with INR \> 2.0 and platelet count \< 100 000/mm3)