The HI-PEITHO study compares two treatment options, both of which are available on the market for the treatment of pulmonary embolism, and randomizes patients in a 1:1 ratio to receive either blood thinners or blood thinners in combination with endovascular intervention to dissolve the blood clot. The aim of the study is to find out whether one of these treatments reduces the risk of death and other serious problems better than the other.
Aim of the study
To investigate whether ultrasound-guided, catheter-directed thrombolysis and anticoagulation is associated with a significant reduction in pulmonary embolism-related mortality, cardiorespiratory decompensation or pulmonary embolism recurrence rate compared to anticoagulation alone within seven days of randomization.
Who can take part?
Patients with acute pulmonary embolism with intermediate to high risk, i.e. without obvious hemodynamic instability at presentation, but with a combination of clinical, imaging and laboratory parameters indicating an increased risk of early death, hemodynamic collapse or pulmonary embolism recurrence will be enrolled in the study.
Procedure
Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with an endovascular device called EkoSonicTM to dissolve blood clots in the lungs. Patients are monitored for 12 months and examined during their hospital stay as well as 7 days, 30 days, 6 months and 12 months after treatment. The study aims to find out whether treatment with EkoSonicTM Endovascular plus anticoagulation is better than anticoagulation alone in reducing the risk of death and other serious events.
Original study name
A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk pulmonary embolism thrombolysis study
BASEC number
2021-D0060