Phase 3
Completed N=59
ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism
Submassive Pulmonary Embolism
Source: ClinicalTrials.gov NCT01166997 ↗
Enrolled (actual)
59
Serious AEs
11.9%
Results posted
Oct 2016
Primary outcomePrimary: Reduction of RV/LV Ratio — 0.03; 0.30 Ratio
◆ Published Evidence
Highly cited
1,113citations · ~93 / year
Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.
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.
Linked Publications
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Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of RV/LV Ratio |
0.03; 0.30 | — |
| PRIMARY Major Bleeding and Intracranial Bleeding at 30 Days. |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with acute PE symptoms 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 2.5
- History of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Recent ( 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 10 mm) right atrial or right ventricular thrombus
Data sourced from ClinicalTrials.gov (NCT01166997) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.