ACTIVE_NOT_RECRUITING

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

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Conditions

Pulmonary EmbolismAcute intermediate-high risk pulmonary embolismUltrasound-facilitated, catheter-directed thrombolysisThrombolysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

Quick Facts

Study Start:2021-08-02
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04790370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80 years, inclusive
  2. * Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery
  3. * Elevated risk of early death/hemodynamic collapse, indicated by at least two of the following new-onset clinical criteria:
  4. 1. ECG-documented tachycardia with heart rate ≥100 beats per minute, not due to hypovolemia, arrhythmia, or sepsis;
  5. 2. SBP ≤ 110 mm Hg for at least 15 minutes;
  6. 3. respiratory rate \> 20 x min-1 or oxygen saturation on pulse oximetry (SpO2) \< 90% (or partial arterial oxygen pressure \< 60 mmHg) at rest while breathing room air;
  7. * Right-to-left ventricular (RV/LV) diameter ratio ≥ 1.0 on CTPA
  8. * Serum troponin I or T levels above the upper limit of normal
  9. * Signed informed consent
  1. * Hemodynamic instability\*, i.e. at least one of the following present:
  2. 1. cardiac arrest or need for cardiopulmonary resuscitation;
  3. 2. need for ECMO, or ECMO initiated before randomization
  4. 3. PE-related shock, defined as: (i) SBP \< 90 mmHg, or vasopressors required to achieve SBP ≥ 90 mmHg, despite an adequate volume status; and (ii) end-organ hypoperfusion (altered mental status; oliguria/anuria; increased serum lactate);
  5. 4. isolated persistent hypotension (SBP \< 90 mmHg, or a systolic pressure drop by at least 40 mmHg for at least 15 minutes), not caused by new-onset arrhythmia, hypovolemia, or sepsis \* Patients who presented with temporary need for fluid resuscitation and/or low-dose catecholamines may be included, provided that they could be stabilized within 2 hours of admission and maintain SBP of ≥ 90 mmHg and adequate organ perfusion without catecholamine infusion.
  6. * Need for admission to an intensive care unit for a reason other than the index PE episode. NB: Patients who test positive for SARS-CoV-2 can be enrolled where the investigator believes that the pulmonary embolism is the dominant pathology in the patient's clinical presentation and qualifying cardiorespiratory parameters.
  7. * Temperature above 39 degrees C / 102.2 degrees F
  8. * Logistical reasons limiting the rapid availability of interventional procedures to treat acute PE (e.g., during the outbreak of an epidemic)
  9. * Index PE symptom duration \> 14 days
  10. * Active bleeding
  11. * History of intracranial or intraocular bleeding at any time
  12. * Stroke or transient ischemic attack within the past 6 months, or previous stroke at any time if associated with permanent disability
  13. * Central nervous system neoplasm, or metastatic cancer
  14. * Major neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or orthopedic surgery or trauma (including syncope-associated with head strike or skeletal fracture) within the past 3 weeks
  15. * Platelet count \< 100 x 109 x L-1
  16. * Patients who have received a once-daily therapeutic dose of LMWH or a therapeutic dose of fondaparinux within 24 hours prior to randomization
  17. * Patients who have received one of the direct oral anticoagulants apixaban or rivaroxaban within 12 hours prior to randomization
  18. * Patients who have received one of the direct oral anticoagulants dabigatran or edoxaban for the index PE episode, as these drugs are not approved for patients who have not received heparin for at least 5 days
  19. * Administration of a thrombolytic agent or a glycoprotein IIb/IIIa receptor antagonist during the current hospital stay and/or within 30 days, for any reason
  20. * Chronic treatment with antiplatelet agents other than low-dose acetylsalicylic acid or clopidogrel 75 mg once daily (but not both). Dual antiplatelet therapy is excluded.
  21. * Chronic treatment with a direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban)
  22. * Chronic treatment with a vitamin K antagonist, or known coagulopathy including severe hepatic dysfunction, with an International Normalized Ratio (INR) \> 1.5
  23. * Pregnancy or lactation
  24. * Previous inclusion in the study
  25. * Known hypersensitivity to alteplase, LMWH or UFH, or to any of the excipients
  26. * Life expectancy less than 6 months

Contacts and Locations

Principal Investigator

Stavros Konstantinides, MD
PRINCIPAL_INVESTIGATOR
University Medical Center Mainz, Mainz, Germany
Kenneth Rosenfield, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital, Boston, Massachusetts, USA

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Cedars - Sinai Medical Center
Los Angeles, California, 90048
United States
Christiana Hospital
Newark, Delaware, 19718
United States
Piedmont Hospital
Atlanta, Georgia, 30309
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Augusta University
Augusta, Georgia, 30904
United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
United States
Methodist Hospitals
Merrillville, Indiana, 46410
United States
Jewish Hospital
Louisville, Kentucky, 40202
United States
Baptist Health East Louisville
Lousville, Kentucky, 40207
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Cooper Hospital - University Medical Center
Camden, New Jersey, 08103
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032
United States
Lenox Hill Hospital
New York, New York, 10075
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Kettering Health
Kettering, Ohio, 45429
United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Seton Medical Center
Austin, Texas, 78705
United States
Houston Methodist Sugarland Hospital
Houston, Texas, 77479
United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908
United States
University of Wisconsin Hospitals
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

  • Stavros Konstantinides, MD, PRINCIPAL_INVESTIGATOR, University Medical Center Mainz, Mainz, Germany
  • Kenneth Rosenfield, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital, Boston, Massachusetts, USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-02
Study Completion Date2026-08

Study Record Updates

Study Start Date2021-08-02
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Acute intermediate-high risk pulmonary embolism
  • Ultrasound-facilitated, catheter-directed thrombolysis
  • Thrombolysis

Additional Relevant MeSH Terms

  • Pulmonary Embolism