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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 24
- 主要终点
- Evolution of the thrombosis at D90±5
研究概览
简要总结
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
- •Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb
- •Patients covered by social security or an equivalent regimen
- •No objection to the use of the data
- •Inclusion in the ULTREC study
排除标准
- •Known current pregnancy
- •Any condition, which may prevent from performing the colour doppler ultrasound test
- •Delay from onset of symptoms to inclusion of more than 10 days
- •Therapeutic anticoagulation for more than 48 hours in the two days prior to consent to ULTREC Study
- •Presence of clinical symptoms or signs of pulmonary embolism
- •Life expectancy less than 3 months
- •Patient unable to adhere to ULTREC protocol follow-up
- •Participants under judicial protection or incapacity
研究组 & 干预措施
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.
干预措施: Color Doppler Ultrasound (Other)
结局指标
主要结局
Evolution of the thrombosis at D90±5
时间窗: 90 days
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.
次要结局
- Validation of positive DVT criteria by comparison between D30±2 and baseline CDUS(30 days)
- Clinical and Imaging characteristics(90 days)
- Venous diameter(90 days)
- Diagnosis of individual characteristics of DVT recurrence(90 days)
- Evolution during follow-up(90 days)
- Baseline characteristics for favorable outcome(1 day)