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ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA)

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ClinicalTrials.gov Identifier: NCT01166997
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
EKOS Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Submassive Pulmonary Embolism Device: EkoSonic Endovascular System Drug: Unfractionated heparin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of RV/LV Ratio [ Time Frame: 24 hours ]
    Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute PE symptoms < 14 days.
  • Filling defect by contrast-enhanced chest CT in at least one main or proximal lower lobe pulmonary artery
  • Right ventricular dysfunction confirmed by echocardiography where the RV/LV end diastolic diameter ratio is ≥ 1.0.

Exclusion Criteria:

  • Age less than 18 years or greater than 80 years
  • Index PE symptom duration > 14 days
  • Insufficient echocardiographic image quality in the apical or subcostal four-chamber view that prohibits the measurement of the right and left ventricular end-diastolic dimensions
  • Known significant bleeding risk
  • Administration of thrombolytic agents, e.g., tissue plasminogen activator, streptokinase, or urokinase, within the previous 4 days
  • Active bleeding
  • Known bleeding diathesis
  • Known coagulation disorder, platelet count < 100 000/mm3, or previous use of vitamin K antagonists with INR > 2.5
  • History of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Recent (< 3 months) GI bleeding.
  • Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
  • Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
  • Estimated glomerular filtration rate (eGFR) < 50 ml/min as calculated by the Cockroft formula.
  • Hemodynamic collapse at presentation defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output < 30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of > 90 mm Hg.
  • Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
  • Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested).
  • Participating in any other investigational drug or device study.
  • Life expectancy < 90 days.
  • Inability to comply with study assessments (e.g. due to geographic distance).
  • Previous enrollment in this study
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
  • Known right-to-left shunt, for example from large patent foramen ovale or atrial septal defect
  • Large (>10 mm) right atrial or right ventricular thrombus
Contacts and Locations
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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


Locations
Germany
Klinikum Lippe-Detmold
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
Universitätsklinikum Heidelberg
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
Switzerland
Inselspital Bern, Kliniken fur Kardiologie and Angiologie
Bern, Switzerland, 3010
Sponsors and Collaborators
EKOS Corporation
Investigators
Principal Investigator: Nils Kucher, Prof Dr med Inselspital Bern, Kliniken für Angiologie und Kardiologie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT01166997     History of Changes
Other Study ID Numbers: EKOS Protocol Number 08
First Posted: July 21, 2010    Key Record Dates
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016
Last Verified: August 2016

Keywords provided by EKOS Corporation:
Pulmonary embolism
Pulmonary thromboembolism
anticoagulation
thrombolysis
ultrasound accelerated thrombolysis

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action