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The ULTREC research project is designed to assess the safety of a negative strategy relying on Colour Doppler Ultrasound (CDUS) for excluding the diagnosis of a new thrombosis. The ULTREC project does not take into account the validity of the CDUS positive criteria used to confirm the diagnosis of Deep Vein Thrombosis (DVT) recurrence.
The risk of considering only the negative strategy is to ignore the possibility of having an improvement in sensitivity and negative predictive value at the expense of specificity and positive predictive value and therefore to increase the false positive rate leading to an overdiagnosis of recurrence and an overtreatment, and a potential bleeding risk.
In the ULTREC-ANCILLARY study, the research will aim at assessing the validity of baseline CDUS positive criteria for the diagnosis of DVT recurrence. As there is no diagnostic standard to which the results could be compared, it is suggested to validate these criteria based on the evolution of the thrombosis on CDUS performed at D90±5.
The hypothesis is that an unchanged appearance under anticoagulation would be in favor of sequelae and will invalidate the initial diagnosis (diagnostic failure)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients included in the ULTREC study who had a recurrence of deep vein thrombosis | Patients who have a baseline CDUS diagnosis of recurrent DVT as identified in the ULTREC study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Color Doppler Ultrasound | Other | Comparison between D90±5 and baseline CDUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the thrombosis at D90±5 | Failure rate judged on the stable aspect of the thrombosis at D90±5 defined by the absence of change in the obstruction and the extent of the thrombosis and the absence of change in the venous diameter under compression (no increase or increase < 4 mm). Vein diameter is measured under compression by ultrasound in a cross-sectional view from the external wall to the external wall of the vein segment. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of positive DVT criteria by comparison between D30±2 and baseline CDUS | Failure rate judged on the stable aspect of the thrombosis at D30±2 defined by the absence of change in the obstruction and the extent of the thrombosis and the absence of change in the venous diameter under compression (no increase or increase < 4 mm) | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients included in the ULTREC study who had a recurrence of deep vein thrombosis
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| Name | Affiliation | Role |
|---|---|---|
| Antoine ELIAS, MD | Centre Hospitalier Intercommunal Toulon La Seyne sur Mer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet d'angiologie Cazanave | Carcassonne | Aude | 11000 | France | ||
| Centre Hospitalier de Carcassonne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23682905 | Background | Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available. | |
| 16947316 | Background | Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4. doi: 10.1002/ajh.20754. |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Clinical and Imaging characteristics | Comparison of clinical and CDUS imaging characteristics between day-0 and day-90 visits | 90 days |
| Evolution during follow-up | Rate of worsening, stabilization and improvement (regression, normalization) Worsening is defined by : a transition from partial obstruction to complete occlusion of a vein segment, an increase ≥ 4 mm in vein diameter measurement or progression of thrombus to another vein segment. Stabilization is defined by : an unchanged pattern. Improvement (regression, normalization) is defined by : a transition from a complete occlusion to a partial obstruction or normalization of the vein segment. | 90 days |
| Baseline characteristics for favorable outcome | Imaging and clinical characteristics of thrombus at Day-0 visit | 1 day |
| Venous diameter | Evolution of venous diameter at day-90 as measured under compression by ultrasound in a cross-sectional view from the external wall to the external wall of the vein segment | 90 days |
| Diagnosis of individual characteristics of DVT recurrence | Failure rate related to the baseline measurement of vein diameter and ULTREC diagnostic recurrence positivity criteria (defined as an occlusive thrombus or a partially obstructive thrombus without reflux, or a free-floating thrombus). | 90 days |
| Carcassonne |
| Aude |
| 11000 |
| France |
| Cabinet d'angiologie Dias | Martigues | Bouches Du Rhône | 13500 | France |
| Cabinet d'angiologie De Mari | Ajaccio | Corse-du-Sud | 20090 | France |
| Cabinet d'angiologie Secondi | Ajaccio | Corse-du-Sud | 20090 | France |
| Cabinet d'angiologie Cazaux | Auch | Gers | 32000 | France |
| Centre Hospitalier d'Auch | Auch | Gers | 32000 | France |
| Cabinet d'angiologie Bonavita | Bastia | Haute-Corse | 20200 | France |
| Clinique Rive Gauche | Toulouse | Haute-Garonne | 31076 | France |
| Clinique des fleurs | Ollioules | Var | 83140 | France |
| Cabinet d'angiologie Bensedrine | Six-Fours-les-Plages | Var | 83140 | France |
| Centre Hospitalier Intercommunal Toulon La Seyne sur Mer | Toulon | Var | 83056 | France |
| 22315267 | Background | Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299. |
| 11790060 | Background | Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98. doi: 10.7326/0003-4819-136-2-200201150-00006. |
| 24615063 | Background | Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |