ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01166997|
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Submassive Pulmonary Embolism||Device: EkoSonic Endovascular System Drug: Unfractionated heparin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Ultrasound accelerated thrombolysis
Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
Device: EkoSonic Endovascular System
The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus.
Active Comparator: Intravenous unfractionated heparin
Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.
Drug: Unfractionated heparin
Intravenous unfractionated heparin used for anticoagulation treatment
- Reduction of RV/LV Ratio [ Time Frame: 24 hours ]Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
- Major Bleeding and Intracranial Bleeding at 30 Days. [ Time Frame: 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.
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): NCT01166997
|Detmold, Germany, 32756|
|Klinikum Dortmund gGmbH|
|Dortmund, Germany, 44137|
|Universitätsklinikum Carl Gustav Carus an der TU Dresden|
|Dresden, Germany, 01307|
|Universitätsklinikum der Ernst-Moritz-Arndt-Universität,|
|Greifswald, Germany, 17475|
|Heidelberg, Germany, 69120|
|Klinikum der Ludwig-Maximilians-Universität (LMU)|
|München, Germany, 81377|
|Christliches Krankenhaus Quakenbrueck|
|Quakenbrueck, Germany, 49610|
|Helios Klinikum Siegburg|
|Siegburg, Germany, 53721|
|SRH Zentralklinikum Suhl|
|Suhl, Germany, 98527|
|Inselspital Bern, Kliniken fur Kardiologie and Angiologie|
|Bern, Switzerland, 3010|
|Principal Investigator:||Nils Kucher, Prof Dr med||Inselspital Bern, Kliniken für Angiologie und Kardiologie|