NCT06622876

Brief Summary

In recent years, with an increase in the frequency of CT examinations, there has also been an increase in the random discovery of pulmonary emboli, often small, as part of examinations performed for other indications. Most of the literature so far deals with the discovery of such findings mainly in oncological patients, and there is relatively little information regarding the frequency of such random discovery in other patient populations. Specifically in the intensive care patient population, we have not yet found any study that examined the detection rates of these findings. Also, there is no consensus regarding how these random findings should be treated from a therapeutic point of view (whether to start treatment with full anticoagulation, and if so, for what period of time). Random pulmonary embolism is often discovered as part of a CT scan done to assess acute lung disease or lung cancer staging. In a study done in oncology patients, 385 chest CT examinations were examined, with a random discovery of pulmonary emboli at a rate of 2.6% . A larger analysis of 8 studies involving 8491 cancer patients found a slightly higher incidence of 3.6%. We would like to check the rate of pulmonary emboli that were randomly discovered in chest CT examinations performed in the intensive care unit for other indications, and the consequences of discoveries - ie starting anti-coagulant treatment and whether there were any complications for starting such treatment (bleeding).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Feb 2025Jan 2027

First Submitted

Initial submission to the registry

September 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

September 29, 2024

Last Update Submit

May 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of incidental pulmonary embolism and related therapeutic consequences

    To determine the rate of incidental pulmonary emboli that were discovered randomly in a CT scan in the intensive care unit and in what percentage of cases the findings caused a change in the patient's drug treatment (starting full anticoagulation therapy ).

    1.8.2020 - 1.8.2024

Interventions

Computed tomography exam of the chest done for other indications other than pulmonary emboli, in which incidental pulmonary embolism was detected.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who were admitted to the ICU between 8/2020 and 8/2024 and underwent chest CT during ICU stay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 2, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations