Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
Condition(s) studied
Investigational drug(s) / intervention(s)
Anticoagulation with heparin: Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)
EkoSonicTM Endovascular System: EkoSonicTM Endovascular System \[ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg\]
Study summary
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE.
Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.
Eligibility
Primary outcome measure(s)
- PE-related mortality — Within seven days of randomization
death resulting from PE - PE recurrence — Within seven days of randomization
nonfatal symptomatic and objectively confirmed recurrence of PE - Cardiorespiratory decompensation or collapse — Within seven days of randomization
Cardiorespiratory collapse or decompensation is defined as at least one of the following criteria: 1. cardiac arrest or need for CPR at any time between randomization and day 7; 2. signs of shock: new-onset persistent arterial hypotension (systolic blood pressure (SBP) below 90 mmHg or SBP drop by at least 40 mm Hg, over at least 15 minutes and despite an adequate volume status; or need for vasopressors to maintain SBP of at least 90 mmHg), accompanied by end-organ hypoperfusion (altered mental status; oliguria/anuria; or increased serum lactate) at any time between randomization and day 7; 3. placement on extracorporeal membrane oxygenation (ECMO) at any time between randomization and day 7; 4. intubation, or initiation of noninvasive mechanical ventilation at any time between randomization and day 7; 5. National Early Warning Score (NEWS) of 9 or higher, between 24 hours and 7 days after randomization, confirmed on consecutive measurements taken twice, 15 minutes apart.
Trial sites (60)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Cedars - Sinai Medical Center | Los Angeles | California | |
| Christiana Hospital | Newark | Delaware | |
| Piedmont Hospital | Atlanta | Georgia | |
| Emory University Hospital | Atlanta | Georgia | |
| Augusta University | Augusta | Georgia | |
| Methodist Hospitals | Merrillville | Indiana | |
| Baptist Health East Louisville | Lousville | Kentucky | |
| University of Maryland School of Medicine | Baltimore | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| University of Michigan Hospitals | Ann Arbor | Michigan | |
| Henry Ford Hospital | Detroit | Michigan | |
| North Mississippi Medical Center | Tupelo | Mississippi | |
| Nebraska Methodist Hospital | Omaha | Nebraska | |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | |
| Newark Beth Israel Medical Center | Newark | New Jersey | |
| Mount Sinai Medical Center | New York | New York | |
| Columbia University Medical Center | New York | New York | |
| Lenox Hill Hospital | New York | New York | |
| University Hospitals of Cleveland | Cleveland | Ohio | |
| Kettering Health | Kettering | Ohio | |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Seton Medical Center | Austin | Texas | |
| Houston Methodist Sugarland Hospital | Houston | Texas | |
| The Heart Hospital Baylor Plano | Plano | Texas | |
| University of Virginia Medical Center | Charlottesville | Virginia | |
| University of Wisconsin Hospitals | Madison | Wisconsin | |
| A.o. LKH Univ.-Kliniken Innsbruck | Innsbruck | Austria | |
| Universitätsklinikum St. Pölten | Sankt Pölten | Austria | |
| Allgemeines Krankenhaus AKH | Vienna | Austria | |
| Austria Klinik Ottakring Vienna | Vienna | Austria | |
| CHU de Besancon | Besançon | France | |
| CHU (Nimes Cedex) | Nîmes | France | |
| Hôpital Européen Georges Pompidou (HEGP) | Paris | France | |
| Uniklinik Aachen | Aachen | Germany | |
| Klinikum Bielefeld | Bielefeld | Germany | |
| GFO Kliniken Bonn | Bonn | Germany | |
| Klinikum Chemnitz | Chemnitz | Germany | |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Germany |
+ 20 more sites — see the full list on the official registry below.
More Boston Scientific Corporation trials in Ireland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04790370 on ClinicalTrials.gov ↗ ← All trials in Ireland