Clinical trial NCT05550038: Diagnostic Performance of General Practitioners in Compression UltraSound
Official title: Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: DVT
Vein thrombosis
Thrombophlebitis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All included patients will have a compression ultrasound performed by the general practitioner followed within 72 hours by a whole leg ultrasound with Doppler performed by the vascular physician.
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the diagnostic efficiency of general practitioners for the diagnosis of proximal deep vein thrombosis of the lower limbs compared with whole-leg ultrasound with Doppler performed by the vascular physician.

Detailed description: After being informed about the study and the potential risks, all patients who have given their written consent and who meet the eligibility criteria will benefit from a 3-point compression ultrasound performed by the general practitioner before being referred for a whole-leg ultrasound with Doppler at the vascular physician.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Management by a general practitioner trained in 3-point venous ultrasound
* Suspicion of deep vein thrombosis by the general practitioner with prescription of a whole-leg Doppler ultrasound by a vascular physician. It is noted that the patient can be included from the moment the general practitioner had planned to refer the patient to the vascular physician for a suspicion of DVT, including in the absence of realization of DDimer on a low probability of DVT. It may also be included in case of positive DDimer tests.
* Signed written consent
* Patient covered by the French social security system

Exclusion Criteria:

* Whole leg ultrasound performed more than 72 hours after the initial examination
* History of homolateral deep vein thrombosis
* Patient objecting to the use of his data
* Refusal of written and signed consent

Primary outcomes:
measure: Diagnostic performance of 3 point venous compression
timeFrame: 72 hours
Secondary outcomes:
measure: The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner.
timeFrame: 72 hours
measure: Duration of the ultrasound performed by the general practitioner in minutes.
timeFrame: 72 hours
measure: The interpretability of ultrasound images by general practitioners
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bayeux
country: France
facility: Bayeux
state: Normandie
city: Avranches
country: France
facility: Avranches
city: Bain-de-Bretagne
country: France
facility: Bain de Bretagne
city: Colombelles
country: France
facility: Colombelles
city: Condé sur vire
country: France
facility: Condé sur vire
city: Honfleur
country: France
facility: Honfleur
city: Ifs
country: France
facility: Ifs
city: Le Chesnay
country: France
facility: Le Chesnay
city: Le Pont de Montvert
country: France
facility: Le pont de montvert
city: Lons-le-Saunier
country: France
facility: Lons-le-Saunier
city: Molay
country: France
facility: Le Molay Littry
city: Ouistreham
country: France
facility: Ouistreham
city: Paris
country: France
facility: Paris rue de Rome
city: Percy
country: France
facility: Percy
city: Ploerdut
country: France
facility: Ploerdut
city: Potigny
country: France
facility: Potigny
city: Sannerville
country: France
facility: Sannerville
city: Saïx
country: France
facility: Saix
city: Troarn
country: France
facility: Troarn
Study officials:
affiliation: Hospital Saint Lo
name: Thomas DELOMAS, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mumoli N, Vitale J, Giorgi-Pierfranceschi M, Sabatini S, Tulino R, Cei M, Bucherini E, Bova C, Mastroiacovo D, Camaiti A, Palmiero G, Puccetti L, Dentali F; PRACTICUS Study Investigators. General Practitioner-Performed Compression Ultrasonography for Diagnosis of Deep Vein Thrombosis of the Leg: A Multicenter, Prospective Cohort Study. Ann Fam Med. 2017 Nov;15(6):535-539. doi: 10.1370/afm.2109.
citation: Mumoli N, Vitale J, Cocciolo M, Cei M, Brondi B, Basile V, Sabatini S, Gambaccini L, Carrara I, Camaiti A, Giuntoli S, Dentali F. Accuracy of nurse-performed compression ultrasonography in the diagnosis of proximal symptomatic deep vein thrombosis: a prospective cohort study. J Thromb Haemost. 2014 Apr;12(4):430-5. doi: 10.1111/jth.12522.
citation: Pomero F, Dentali F, Borretta V, Bonzini M, Melchio R, Douketis JD, Fenoglio LM. Accuracy of emergency physician-performed ultrasonography in the diagnosis of deep-vein thrombosis: a systematic review and meta-analysis. Thromb Haemost. 2013 Jan;109(1):137-45. doi: 10.1160/TH12-07-0473. Epub 2012 Nov 8.
citation: Lee JH, Lee SH, Yun SJ. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department: A meta-analysis. Medicine (Baltimore). 2019 May;98(22):e15791. doi: 10.1097/MD.0000000000015791.