The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio will be significantly reduced in the treatment arm compared to the control arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
59
The EkoSonic Endovascular System will be used to deliver \< 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus.
Intravenous unfractionated heparin used for anticoagulation treatment
Klinikum Lippe-Detmold
Detmold, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany
Universitätsklinikum der Ernst-Moritz-Arndt-Universität,
Reduction of RV/LV Ratio
Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
Time frame: 24 hours
Major Bleeding and Intracranial Bleeding at 30 Days.
Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.
Time frame: 30 days
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Greifswald, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinikum der Ludwig-Maximilians-Universität (LMU)
München, Germany
Christliches Krankenhaus Quakenbrueck
Quakenbrück, Germany
Helios Klinikum Siegburg
Siegburg, Germany
SRH Zentralklinikum Suhl
Suhl, Germany
Inselspital Bern, Kliniken fur Kardiologie and Angiologie
Bern, Switzerland