Diagnostic Performance of General Practitioners in Compression UltraSound

Deep Vein Thrombosis Clinical Trial

— GPCUS  

Official title:

Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550038
• Other study ID #: 22-0114
• Secondary ID: 22.02437.0000912
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: October 3, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Caen
• Contact: THOMAS DELOMAS, Dr
• Phone: +33603786064
• Email: thomas.delomas[@]ch-stlo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 3, 2024
• Est. primary completion date: October 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• Compression ultrasound
Patients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis.

Locations

Country	Name	City	State
France	Avranches	Avranches
France	Bain de Bretagne	Bain-de-Bretagne
France	Bayeux	Bayeux	Normandie
France	Colombelles	Colombelles
France	Condé sur vire	Condé sur vire
France	Honfleur	Honfleur
France	Ifs	Ifs
France	Le Chesnay	Le Chesnay
France	Le pont de montvert	Le Pont de Montvert
France	Lons-le-Saunier	Lons-le-Saunier
France	Le Molay Littry	Molay
France	Ouistreham	Ouistreham
France	Paris rue de Rome	Paris
France	Percy	Percy
France	Ploerdut	Ploerdut
France	Potigny	Potigny
France	Saix	Saïx
France	Sannerville	Sannerville
France	Troarn	Troarn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of 3 point venous compression	The diagnostic performance (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value) of 3-point venous compression ultrasound performed by general practitioners for the diagnosis of proximal venous thrombosis of the lower limbs compared to the usual recommended examination (whole leg ultrasound by a vascular physician)	72 hours
Secondary	The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner.	For each patient, the general practitioner must say whether or not he or she was successful in performing the compression ultrasound.; The measure will be the percentage of ultrasound examinations considered successful by general practitioners.	72 hours
Secondary	Duration of the ultrasound performed by the general practitioner in minutes.	Duration of the ultrasound performed by the general practitioner in minutes.	72 hours
Secondary	The interpretability of ultrasound images by general practitioners	The interpretability of ultrasound images by general practitioners. For each patient, the general practitioner must note the result of his or her ultrasound (compressibility or total incompressibility of the veins on the 3 points studied). He must also correctly interpret the ultrasound result (presence of venous thrombosis in case of total incompressibility of the vein or absence of thrombosis in case of total compressibility of the vein).; The measure will be the percentage of correct interpretation of the compression test.	72 hours