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Recruiting Observational

Pulmonary Thromboembolism in Cancer Patients: Early Rule-out From the Emergency Department

NCT06761144 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-07-13
Last updated
2025-01-07

Condition(s) studied

Pulmonary Thromboembolisms

Study summary

Pulmonary thromboembolism is a frequent complication of cancer; in some cases, it is diagnosed occasionally during diagnostic examinations as part of the regular follow-up of the disease. Not all patients diagnosed with thromboembolism present symptoms; therefore, after appropriate investigations during observation in the emergency room and/or a short hospitalisation in Emergency Medicine, they could be discharged home, avoiding lengthy hospitalisations that would have a considerable impact on their health and psychological condition.

The goal of this observational study is to compare the efficacy of several assessment scales for use by physicians to identify patients at low risk of developing serious complications of pulmonary embolism within 30 days of diagnosis, in order to be able to identify a group of low-risk patients who could be discharged early from the emergency department/emergency medicine safely.

What does participation in this study entail compared to the normal care you receive and what are your responsibilities as a participant? At the time of patient enrolment in the emergency room/emergency medicine, the data necessary for the calculation of 6 scoring systems will be collected, which will take approximately 5 minutes.

The patient enrolled in the study will be contacted by telephone in order to assess the state of health; the call will take approximately 1 minute and will take place 30 days after access to the emergency room.

Participation in the study does not entail any obligation or restriction, nor will it be charged for.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of pulmonary embolism (symptomatic and/or incidental) * Active onco-haematological disease (disease followed in oncological/haematological and/or metastatic setting) * Informed consent to the study Exclusion Criteria: * Patients returning to the Emergency Department for complications related to previously diagnosed pulmonary embolism

Primary outcome measure(s)

  • Evaluate mortality in patients at low risk of major adverse events (death/respiratory failure/hospitalisation) — From enrollment to the follow-up at 30 days
    The primary objective is to evaluate the already existing and used prognostic scores (HESTIA, PESI, sPESI, POMPE-C, EPIPHANY Index, RIETE) in cancer patients with incidental pulmonary embolism in order to identify the one with the greatest effectiveness for identifying patients at low risk of major adverse events at 30 days, who can therefore be discharged early and safely from the emergency department.

Trial sites (1)

FacilityCityRegionStatus
Eleonora Tubertini Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06761144 on ClinicalTrials.gov ↗ ← All trials in Italy