Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

Summary

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

Keywords

Pulmonary Embolism, Catheter-Directed Therapy (CDT), Anticoagulant Therapy, Catheter-Directed Therapy, Catheter-Directed Therapy (CDT) plus Anticoagulation

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
  2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography

You CAN'T join if...

  1. Age < 18 years
  2. Systolic blood pressure < 90 mmHg for >15 consecutive minutes or > 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment.
  3. Symptom duration > 14 days for the current PE episode
  4. Irreversible INR > 3
  5. Irreversible Thrombocytopenia (Platelets < 50,000/microliter)
  6. Creatinine > 2.0 mg/dl
  7. Hemoglobin < 7.0 g/dl
  8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
  9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used
  10. Life expectancy < 1 year
  11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
  12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
  13. Unable or unwilling to provide informed consent
  14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Locations

  • UC Davis Health accepting new patients
    Sacramento 5389489 California 5332921 95817 United States
  • Scripps Memorial Hospital, La Jolla accepting new patients
    San Diego 5391811 California 5332921 92121 United States
  • The Lundquist Institute accepting new patients
    Torrance 5403022 California 5332921 90502 United States
  • Stanford Medicine accepting new patients
    Palo Alto 5380748 California 5332921 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NYU Langone Health
ID
NCT05591118
Phase
Phase 3 Pulmonary Embolism Research Study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated