Emergency Medicine Pulmonary Embolism Testing Multicentre Study: Lung Diseases and Conditions – Pulmonary Embolism
2024 APR 01 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT06320236 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Actual Start Date | |
| 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 |
| 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 | |
| Primary Completion Date | |
| 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 |
| No | |
| Contacts | Primary contact: Natasha S Clayton, CRA, RA, 4165663590, natasha.clayton@queensu.ca |
| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT06320236 |
| Other Study ID Numbers | 4603 |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | No |
| Plan to Share Data (IPD) Description | Not Provided |
| Dr. |
|
| Collaborators | |
| Investigators | Principal Investigator: |
| Information Provided By | Queen’s University |
| Verification Date |
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