Clinical trial NCT05300139: Ancillary Study of the ULTREC Project
Official title: Validation of Ultrasonic Positive Diagnosis Criteria of Ipsilateral Deep Vein Thrombosis Recurrence of the Lower Limbs Based on Thrombosis Evolution at a 3-month Follow-up Under Anticoagulation: The ULTREC Project Ancillary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Keywords: Deep vein thrombosis
Recurrence
Colour doppler ultrasound
Diagnostic strategy
Outcome
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in the ULTREC study who had a recurrence of deep vein thrombosis

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
3. Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb
4. Patients covered by social security or an equivalent regimen
5. No objection to the use of the data
6. Inclusion in the ULTREC study

Exclusion Criteria:

1. Known current pregnancy
2. Any condition, which may prevent from performing the colour doppler ultrasound test
3. Delay from onset of symptoms to inclusion of more than 10 days
4. Therapeutic anticoagulation for more than 48 hours in the two days prior to consent to ULTREC Study
5. Presence of clinical symptoms or signs of pulmonary embolism
6. Life expectancy less than 3 months
7. Patient unable to adhere to ULTREC protocol follow-up
8. Participants under judicial protection or incapacity

Primary outcomes:
measure: Evolution of the thrombosis at D90±5
timeFrame: 90 days
Secondary outcomes:
measure: Validation of positive DVT criteria by comparison between D30±2 and baseline CDUS
timeFrame: 30 days
measure: Clinical and Imaging characteristics
timeFrame: 90 days
measure: Evolution during follow-up
timeFrame: 90 days
measure: Baseline characteristics for favorable outcome
timeFrame: 1 day
measure: Venous diameter
timeFrame: 90 days
measure: Diagnosis of individual characteristics of DVT recurrence
timeFrame: 90 days
Other outcomes:
Locations:
city: Carcassonne
country: France
facility: Cabinet d'angiologie Cazanave
state: Aude
city: Carcassonne
country: France
facility: Centre Hospitalier de Carcassonne
state: Aude
city: Martigues
country: France
facility: Cabinet d'angiologie Dias
state: Bouches Du Rhône
city: Ajaccio
country: France
facility: Cabinet d'angiologie De Mari
state: Corse-du-Sud
city: Ajaccio
country: France
facility: Cabinet d'angiologie Secondi
state: Corse-du-Sud
city: Auch
country: France
facility: Cabinet d'angiologie Cazaux
state: Gers
city: Auch
country: France
facility: Centre Hospitalier d'Auch
state: Gers
city: Bastia
country: France
facility: Cabinet d'angiologie Bonavita
state: Haute-Corse
city: Toulouse
country: France
facility: Clinique Rive Gauche
state: Haute-Garonne
city: Ollioules
country: France
facility: Clinique des fleurs
state: Var
city: Six-Fours-les-Plages
country: France
facility: Cabinet d'angiologie Bensedrine
state: Var
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Antoine ELIAS, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.