NCT04882579|CompletedDMC
Point-of-care Ultrasound in Suspected Pulmonary Embolism
Point-of-care Ultrasound in the Diagnostic Work-up of Suspected Pulmonary Embolism - a Multicenter Randomized Controlled Trial
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Point-of-care Ultrasound in the Diagnostic Work-up of Suspected Pulmonary Embolism - a Multicenter Randomized Controlled Trial
Sponsor study identifier
interventional
150
1 country
5
Study Start
June 15, 2021
Actual (reported)Primary Completion
February 1, 2023
Actual (reported)Study Completion
July 1, 2023
Actual (reported)Pulmonary embolism (PE) is a common cardiovascular condition with an estimated incidence of 0.60 to 1.12 per 1000 inhabitants in the United States of America, and the diagnosis is challenging as patients with PE present with a wide array of symptoms. Computed tomography pulmonary angriography (CTPA) and lung ventilation-perfusion scintigraphy (VQ) are considered the gold-standards in PE-diagnostics but may not always be feasible. CTPA is contraindicated by contrast allergy or renal failure and both modalities require involvement of multiple staff-members and transport of the patient. Lung scintigraphy cannot be performed in an emergency situation, with unstable patients and patients unable to comply to the examination. Ultrasound represent a possible tool in confirming or dismissing clinical PE suspicion. Ultrasound is non-invasive and can be performed bedside by the clinician, an approach known as point-of-care ultrasound (PoCUS), reducing both time, radiation-exposure and costs. The aim of this study is to investigate whether integrating cardiac, lung and deep venous ultrasound in the clinical evaluation of suspected PE reduces the need for referral to CTPA or lung scintigraphy, during emergency department work up, while maintaining safety standards.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 12, 2021
Actual (reported)May 12, 2021
Actual (reported)June 15, 2021
Actual (reported)February 1, 2023
Actual (reported)July 1, 2023
Actual (reported)Proportion of patients referred to CTPA or VQ after multiorgan PoCUS
Up to 24 hours
Number of adverse events in the intervention and control group after inclusion, including readmission, serious bleeding or death
3 months
Number of hours until initiation of relevant treatment after clinical evaluation in the control and intervention group.
Up to 24 hours
Proportion of included patients diagnosed with PE in the control and intervention group
Up to 24 hours
Proportion of patients diagnosed with alternative diagnosis following clinical evaluation in the intervention and control group
Up to 24 hours
Proportion of patients in the intervention and control group discharged to their own home following clinical evaluation
Up to 24 hours
Patients allocated to the PoCUS investigation arm will receive an ultrasound investigation resulting in either confirmation or dismissal of pulmonary embolism suspicion or requiring CTPA or VQ
Patients allocated to the control group will continue with CTPA or VQ without PoCUS investigation
The intervention consists of three ultrasound modalities: 1. Cardiac ultrasound assessing signs of right ventricular strain or other obvious pathology. 2. Deep venous ultrasound assessing presence of a deep venous thrombus 3. Lung ultrasound assessing presence of pulmonary infarctions, pleural effusion, pneumothorax or interstitial syndrome.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Esbjerg Hospital
Esbjerg, 6700, Denmark
Kolding Hospital
Kolding, 6000, Denmark
Odense University Hospital
Odense, 5000, Denmark
Slagelse hospital
Slagelse, 4200, Denmark
Svendborg Hospital
Svendborg, 5700, Denmark
Falster C, Morkenborg MD, Thrane M, Clausen J, Arvig M, Brockhattingen K, Biesenbach P, Paludan L, Nielsen RW, Nhi Huynh TA, Poulsen MK, Brabrand M, Moller JE, Posth S, Laursen CB. Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study). Lancet Reg Health Eur. 2024 May 28;42:100941. doi: 10.1016/j.lanepe.2024.100941. eCollection 2024 Jul.
Casper Falster, MD
Odense University Hospital
Christian B Laursen, Prof. MD
Odense University Hospital
150 participants (actual enrollment reported by the registry).
First Submitted
April 12, 2021
First Posted
May 12, 2021
Study Start
Effect of a Global Simplified Strategy on Thromboembolic Events in Emergency Department Patients with Suspected Pulmonary Embolism
Contact the study team to confirm eligibility.
June 15, 2021
Actual (reported)Primary Completion
February 1, 2023
Actual (reported)Study Completion
July 1, 2023
Actual (reported)Last Updated
November 3, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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