Emergency Medicine Pulmonary Embolism Testing Multicentre Study: Lung Diseases and Conditions - Pulmonary Embolism - Insurance News | InsuranceNewsNet

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April 1, 2024 Newswires
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Emergency Medicine Pulmonary Embolism Testing Multicentre Study: Lung Diseases and Conditions – Pulmonary Embolism

NewsRx Hematology Daily

2024 APR 01 (NewsRx) -- By a News Reporter-Staff News Editor at NewsRx Hematology Daily -- Staff editors report on the newly launched clinical trial, NCT06320236, which has the following summary description: “It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although positive results are low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging. We have created a new tool (called Adjust-Unlikely) which could safely reduce pulmonary embolism imaging in Canada. Our research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results. Our study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism.”

As a matter of record, on March 21, 2024, NewsRx staff editors report that the available information provided by Queen’s University on this trial include:

Tracking Information

Trial Identifier NCT06320236
First Submitted Date March 13, 2024
First Posted Date March 20, 2024
Results First Submitted Date Not Provided
Results First Posted Date Not Provided
Last Update Submitted Date March 13, 2024
Last Update Posted Date March 20, 2024
Primary Completion Date September 30, 2026
Actual Start Date January 1, 2024
Current Primary Outcome Measures •Venous thrombosis [ Time Frame: 30 days ]
Current Secondary Outcome Measures •Venous thrombosis [ Time Frame: 90 days ]
•Index presentation Adjust-Unlikely testing results [ Time Frame: 90 days ] -- Positive or negative ‘Adjust-Unlikely’ testing result
Other Outcome Measures Not Provided
Change History Complete list of historical revisions of study NCT06320236

Descriptive Information

Brief Title Emergency Medicine Pulmonary Embolism Testing Multicentre Study
Official Title Emergency Medicine Pulmonary Embolism Testing Multicentre Study
Brief Summary It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although positive results are low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging. We have created a new tool (called Adjust-Unlikely) which could safely reduce pulmonary embolism imaging in Canada. Our research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results. Our study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism.
Detailed Description Not Provided
Study Type Observational
Study Phase Not Provided
Study Design Observational Model: Cohort
Time Perspective: Prospective
Condition Pulmonary Embolism
D-dimer
Diagnosis
Intervention •Diagnostic Test: Adjust-Unlikely
Pulmonary embolism will be excluded during emergency department assessment by the combination of: ‘Pulmonary embolism is the most likely diagnosis’ as per the treating physician AND a D-dimer result < 500 ug/L fibrinogen equivalent units; ‘Pulmonary embolism is not the most likely diagnosis’ AND D-dimer < age-adjusted threshold; or, A negative computed tomography scan, planar ventilation perfusion scan or ventilation perfusion-SPECT. Emergency departments will use their local laboratory D-dimer assay.
Study Arms •Emergency department patients tested for pulmonary embolism.
Interventions:
⚬Diagnostic Test: Adjust-Unlikely

Recruitment Information

Recruitment Status Recruiting
Estimated Enrollment 4000
Estimated Completion Date September 30, 2027
Primary Completion Date September 30, 2026 (Final data collection date for primary outcome measure)
Eligibility Inclusion Criteria: Emergency department patient who is tested by an emergency physician for PE Exclusion Criteria: Patient is < 18 years of age No documentation of whether PE is the most likely diagnosis D-dimer is not tested or else not resulted during the emergency visit The D-dimer level is known before documentation of whether PE is the most likely diagnosis The D-dimer is ordered prior to the physician assessing the patient The patient has previously registered that they opt out of all research at the participating site The patient leaves against medical advice The patient has had PE or deep vein thrombosis imaging (CT pulmonary angiogram, ventilation-perfusion scan or lower limb ultrasound) within prior 30 days There is a new (non-PE) indication for anticoagulation The patient was initiated on treatment for presumed PE prior to PE testing The patient has previously been enrolled into the study The patient has a prior history of lower extremity deep vein thrombosis without availability of a baseline ultrasound scan The patient was transferred from another hospital organization The patient does not reside in Ontario The patient has no valid Ontario Health Insurance Plan card
Sex/Gender Sexes Eligible for Study: All
Ages 18 years and older
Accepts Healthy Volunteers No
Contacts Primary contact: Natasha S Clayton, CRA, RA, 4165663590, [email protected]
Listed Location Countries Canada
Removed Location Countries

Administrative Information

NCT Number NCT06320236
Other Study ID Numbers 4603
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
Plan to Share Data No
Plan to Share Data (IPD) Description Not Provided
Responsible Party Dr. Kerstin de Wit, Queen’s University
Collaborators Canadian Institutes of Health Research (CIHR)
Investigators Principal Investigator: Kerstin de Wit, MD, Queens University
Information Provided By Queen’s University
Verification Date March 2024

(Our reports deliver fact-based news of research and discoveries from around the world.)

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