Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion 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), Embolism, Anticoagulants, 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 California 95817 United States
  • Scripps Memorial Hospital, La Jolla accepting new patients
    San Diego California 92121 United States
  • The Lundquist Institute accepting new patients
    Torrance California 90502 United States
  • Stanford Medicine accepting new patients
    Palo Alto California 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