PE-TRACT: PULMONARY EMBOLISM – THROMBUS REMOVAL WITH CATHETER-DIRECTED THERAPY
PE-TRACT is a clinical trial comparing two standard treatment options for pulmonary embolism: blood thinner medicine and catheter-directed therapy.
About
The PE-TRACT study includes patients who have been diagnosed with a pulmonary embolism (blood clots in their lungs). The study is designed to identify the best way to treat pulmonary embolism, specifically, regarding which treatment helps people do better in terms of breathing, heart function and ability to exercise over time. There are currently two standard treatments available for pulmonary embolism, both of which have been shown to help patients survive and effectively treat patients in the hospital. One approach is to dissolve or remove the clot using catheter-directed therapy (CDT). This procedure is done by inserting a thin plastic tube (catheter) into a vein, typically in the groin or neck. The catheter is guided toward the blood clots in the lungs using x-ray. Then, a clot- dissolving medicine or a vacuum can be used to dissolve or suck out the clot. Patients treated with CDT also take blood thinner (anticoagulation) medicine. The other standard approach is not to have CDT and to take an anticoagulation medicine alone. The purpose of the PE-TRACT study is to compare these two standard approaches to treatment, and determine if one is better or worse, especially regarding patients’ ability to exercise and do other activities over the long term. PE-TRACT is the first large, multi-center randomized trial of catheter-directed therapy for pulmonary embolism. The study results will improve public health outcomes and define the best course of treatment for submassive PE.
Eligibility Criteria
Inclusion Criteria
· Symptomatic PE diagnosed by contrast-enhanced CTA with involvement of a main or lobar pulmonary artery branch; and
· Right ventricular dilation as defined by the presence of an RV/LV ratio > 1 on CTA
Please note: there is no upper age limit for this trial.
Exclusion Criteria
· Age < 18 years
· Systolic blood pressure < 90 mmHg for >15 consecutive minutes or > 40 mmHg drop from baseline, or vasopressor requirement or mechanical circulatory support for blood pressure (i.e., massive PE), occurring within 1 hour prior to eligibility assessment
· Symptom duration > 14 days for the current PE episode
· Irreversible INR > 3.0
· Platelets < 50,000/microliter
· Estimated glomerular filtration rate (eGFR) < 30 ml/min (as calculated by the clinical site’s standard method)
· Hemoglobin < 7.0 g/dl at the time of randomization
· Pregnancy (positive urine or blood pregnancy test [a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential])
· Allergy or hypersensitivity to rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used
· Life expectancy < 1 year as determined by the site investigator
· Chronic inability to independently walk prior to the current PE episode (e.g., wheelchair, walker or cane dependent, paraplegic and/or bed-bound)
· Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
· Unable or unwilling to provide informed consent
· Major contraindication or unsuitability for all CDT methods available at the clinical site (intended CDT method to be designated before randomization, see section 6.2.1)
· Current participation in another interventional treatment study for deep vein thrombosis (DVT) or PE
· Absolute contraindication to anticoagulation or inability to anticoagulate
Primary Investigator
Dr. Joseph Hughes is an interventional radiologist with over 10 years of clinical and research experience. He is an assistant professor at the Virginia Tech Carilion School of Medicine and serves as the vice chair of education and research for the Department of Radiology. He is board certified in interventional and diagnostic radiology. He completed his residency and fellowship at Penn State Milton S. Hershey Medical Center and completed his surgical internship at Carilion Roanoke Memorial Hospital.
Contact Information
Christina Case, MS
Clinical Research Coordinator
