Using compression ultrasound to rule out deep vein thrombosis in low-risk patients
Evaluation of the Predictive Value of Compression Venous Ultrasound by the Emergency Physician for Excluding the Diagnosis of Proximal Deep Vein Thrombosis (DVT) in Patients With Non-high Clinical Pretest Probability
This study tests if using compression ultrasound can help doctors rule out deep vein thrombosis in low-risk patients who show symptoms when they come to the emergency room.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04917328 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of compression ultrasound as a diagnostic tool for ruling out deep vein thrombosis (DVT) in patients with a low probability of the condition, as determined by the modified Wells score. The researchers hypothesize that compression ultrasound can provide accurate results comparable to the standard D-dimer assay. Adult patients presenting to the emergency department with symptoms suggestive of DVT will be included if they meet specific criteria. The study aims to improve diagnostic accuracy and patient care in emergency settings.
Who should consider this trial
Good fit: Ideal candidates are adults presenting to the emergency department with clinical suspicion of DVT and a low probability score.
Not a fit: Patients with a high probability of DVT or those with suspected pulmonary embolism will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could streamline the diagnostic process for DVT, reducing unnecessary tests and improving patient outcomes.
How similar studies have performed: While compression ultrasound is commonly used, this specific approach in low-risk patients is less established, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patient * Patient presenting to the emergency department with clinical suspicion of DVT (i.e. pain and/or lower extremity edema). * Patient with a non-high probability according to the modified Wells score, i.e. a score of 0 or 1 * Subject with a social health insurance plan * Subject able to understand the objectives and risks of the research and to give a signed and dated informed consent Exclusion Criteria: * Patient with suspected pulmonary embolism * Patient with a high probability of DVT * Impossible to perform a whole leg doppler ultrasound within 5 days * Pregnant or breast-feeding woman, on patient's declaration * Subject under court protection * Subject under guardianship or curatorship
Where this trial is running
Strasbourg
- CHU Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Pierrick LE BORGNE, MD
- Email: pierrick.leborgne@chru-strasbourg.fr
- Phone: 03.88.12.86.90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.