Diagnostic Performance of General Practitioners in Compression UltraSound

NCT ID: NCT05550038

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2024-01-23

Brief Summary

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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

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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.

Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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compression ultrasound

All patients receive a 3-point compression ultrasound followed within 72 hours by a whole-leg ultrasound with Doppler performed by a vascular physician.

Group Type EXPERIMENTAL

Compression ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Compression ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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three-point compression three-point compression ultrasound three-point point-of-care ultrasound technique

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas DELOMAS, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Saint Lo

Locations

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Bayeux

Bayeux, Normandy, France

Site Status

Avranches

Avranches, , France

Site Status

Bain de Bretagne

Bain-de-Bretagne, , France

Site Status

Colombelles

Colombelles, , France

Site Status

Condé sur vire

Condé-sur-Vire, , France

Site Status

Honfleur

Honfleur, , France

Site Status

Ifs

Ifs, , France

Site Status

Le Chesnay

Le Chesnay, , France

Site Status

Le pont de montvert

Le Pont-de-Montvert, , France

Site Status

Lons-le-Saunier

Lons-le-Saunier, , France

Site Status

Le Molay Littry

Molay, , France

Site Status

Ouistreham

Ouistreham, , France

Site Status

Paris rue de Rome

Paris, , France

Site Status

Percy

Percy, , France

Site Status

Ploerdut

Ploërdut, , France

Site Status

Potigny

Potigny, , France

Site Status

Saix

Saïx, , France

Site Status

Sannerville

Sannerville, , France

Site Status

Troarn

Troarn, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29133492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24495051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23138420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31145304 (View on PubMed)

Other Identifiers

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22.02437.000091

Identifier Type: OTHER

Identifier Source: secondary_id

2022-A01244-39

Identifier Type: OTHER

Identifier Source: secondary_id

22-0114

Identifier Type: -

Identifier Source: org_study_id

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