Deep Vein ThrombosisGPCUSNCT05550038
Diagnostic Performance of General Practitioners in Compression UltraSound
A study testing Compression ultrasound in people with Deep Vein Thrombosis, run by University Hospital, Caen at 19 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Compression ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 19 sitesFrance
- Study dates
- 3 Oct 2022to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Avranches
Avranches, 50300
Bain de Bretagne
Bain-de-Bretagne, 35470
Bayeux
Bayeux, Normandy, 14400
Colombelles
Colombelles, 14460
Condé sur vire
Condé-sur-Vire, 50890
Honfleur
Honfleur, 14600
Ifs
Ifs, 14123
Le Chesnay
Le Chesnay, 78150
Le pont de montvert
Le Pont-de-Montvert, 48220
Lons-le-Saunier
Lons-le-Saunier, 39000
Le Molay Littry
Molay, 14330
Ouistreham
Ouistreham, 14150
Paris rue de Rome
Paris, 75017
Percy
Percy, 50410
Ploerdut
Ploërdut, 56160
Potigny
Potigny, 14420
Saix
Saïx, 81710
Sannerville
Sannerville, 14940
Troarn
Troarn, 14670
About this study
Official title: Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs
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.
Read the 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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Compression ultrasound
- Keywords
- DVT, Vein thrombosis, Thrombophlebitis
- Medical subject headings
- Venous Thrombosis, Thrombophlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression ultrasoundDiagnostic test
Also called three-point compression, three-point compression ultrasound, three-point point-of-care ultrasound technique
Patients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis.
| Study group | Role | What they receive |
|---|---|---|
| compression ultrasound | Experimental | All patients receive a 3-point compression ultrasound followed within 72 hours by a whole-leg ultrasound with Doppler performed by a vascular physician. Receives: Diagnostic Test: Compression ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 72 hours
Secondary outcomes (3)
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.
Measured: 72 hours
Duration of the ultrasound performed by the general practitioner in minutes.
Duration of the ultrasound performed by the general practitioner in minutes.
Measured: 72 hours
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start3 Oct 2022
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Why it stopped: Lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas DELOMAS, Dr, Principal investigator, Hospital Saint Lo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550038
- Sponsor's protocol ID
- 22-0114
- Other IDs
- 22.02437.000091, 2022-A01244-39
- Acronym
- GPCUS
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29133492Mumoli 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.
PubMed 24495051Pomero 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.
PubMed 23138420Lee 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.
PubMed 31145304
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs
- ClinicalTrials.gov ID
- NCT05550038
- Acronym / sponsor ID
- GPCUS / 22-0114
- Conditions
- Deep Vein Thrombosis
- Keywords
- DVT, Vein thrombosis, Thrombophlebitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusions
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| compression ultrasound | Experimental | Diagnostic Test: Compression ultrasoundAll patients receive a 3-point compression ultrasound followed within 72 hours by a whole-leg ultrasound with Doppler performed by a vascular physician. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression ultrasoundAlso: three-point compression, three-point compression ultrasound, three-point point-of-care ultrasound techniquePatients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis. | Diagnostic test | compression ultrasound |
Primary outcome
Diagnostic performance of 3 point venous compression
Time frame: 72 hours
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)
3 secondary outcomes
The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner.
Time frame: 72 hours
Duration of the ultrasound performed by the general practitioner in minutes.
Time frame: 72 hours
The interpretability of ultrasound images by general practitioners
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 29133492Mumoli 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.
- Background: PubMed 24495051Mumoli 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.
- Background: PubMed 23138420Pomero 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.
- Background: PubMed 31145304Lee 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.
- Individual participant dataSharing planned: No
Related trials for Deep Vein Thrombosis
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas DELOMAS, Dr principal investigator
Hospital Saint Lo
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression ultrasound in people with Deep Vein Thrombosis, run by University Hospital, Caen at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of 3 point venous compression (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550038, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.