Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy

Launched by UNIVERSITY HOSPITAL, BREST · Dec 1, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating two different ways to check for a condition called pulmonary embolism (PE) in patients who have active cancer. PE occurs when a blood clot travels to the lungs, which can be very serious. The study aims to see if using a special approach called the YEARS algorithm can safely identify patients who do not have PE, compared to the standard method of using a CT scan of the lungs (called computed tomography pulmonary angiography, or CTPA) alone.

To participate in the trial, individuals must be at least 18 years old and have a suspected PE, along with an active type of cancer that was diagnosed within the last six months or is currently being treated. Patients will be closely monitored throughout the trial to evaluate the effectiveness and safety of these two methods. It's important to note that those with certain medical conditions or who are already receiving specific treatments may not be eligible to join. Overall, this study hopes to improve how doctors diagnose PE in cancer patients, making the process safer and more efficient.

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Eligibility criteria

• Inclusion Criteria:
• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• • Clinically suspected PE as judged by the treating clinician
• • Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy
• • Outpatients and hospitalized patients
• • Age ≥ 18 years
• • Signed and dated informed consent, available for start of the trial procedure
• Exclusion Criteria:
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• • Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent
• • Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment
• • Contraindication to CTPA
• • contrast allergy
• Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following:
• • systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>120 beats per minute or SBP drop by \> 40 mm Hg, for \> 15 min
• • need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \> 100 mmHg
• • Need for cardiopulmonary resuscitation
• • Inability to follow-up
• • Life expectancy less than 3 months