Pulmonary Embolism
Conditions
Brief summary
Recent evidence supports the use of catheter-interventional techniques for the treatment of intermediate-high-risk pulmonary embolism. While there is evidence supporting the use of catheter-thrombectomy and alternatively local fibrinolysis, less is known on the combination of both approaches. The investigators aim to assess the effects of a combined interventional local fibrinolysis and catheter-thrombectomy and to compare them with conventional treatment in a cohort of patients with intermediate-high-risk pulmonary embolism.
Interventions
DEVICEcombined catheter-thrombectomy and local fibrinolysis
combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment
OTHERconventional treatment
conventional treatment of pulmonary embolism
Sponsors
Heart Center Leipzig - University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* confirmed intermediate high-risk pulmonary embolism * age \>= 18 years
Exclusion criteria
* high-risk pulmonary embolism * contraindications for catheter-based treatment * known allergy to anticoagulant treatment or fibrinolytics * pregnancy * participation in other randomized trials * patients under legal supervision or guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RV-LV-Ratio | Day 1 after randomization | Change in right to left ventricular diameter ratio |
| clinical efficacy | Day 1 after randomization | quotient of systolic systemic blood pressure over heart rate and respiratory rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pulmonary artery pressure | 1 day, 30 days and 1 year after randomization | difference in estimated pulmonary artery pressure between the groups |
| RV/LV-ratio | 30 days and 1 year after randomization | difference in RV/LV-ratio |
| TAPSE | 1 day, 30 days and 1 year after randomization | difference in TAPSE as assessed by transthoracic echocardiogram |
| Mortality | 1 day, 30 days, 1 year after randomization | difference in mortality between the treatment groups |
| Bleeding | 1 day, 30 days and 1 year after randomization | difference in BARC bleeding events between the groups |
| Troponin and NT-proBNP | 30 days and 1 year after randomization | difference in high-sensitivity Troponin T and NT-proBNP between the groups |
| difference in RA volume between the groups | 1 day, 30 days and 1 year after randomization | RA volume between the groups |
| Right heart failure | 30 days and 1 year after randomization | difference in new onset right heart failure between the groups |
Countries
Germany
Outcome results
None listed