Determine the Proportion of Patients With Disabling Post Thrombotic Syndrome (Moderate or Severe) in the Long Term Within the Cohort of Patients Who Participated in the Trial CELEST Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Proportion of patients with moderate-severe PTS in the whole cohort
研究概览
简要总结
The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate.
The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.
详细描述
The CELEST double blind RCT demonstrated that 25mmHg elastic compression stockings (ECS) were non inferior to 35mmHg ECS to prevent post thrombotic syndrome (PTS) 2 years after a first proximal deep vein thrombosis (DVT). Likely because of lack of statistical power the investigators were not able to demonstrate that 25mmHg ECS were superior in the overall RCT population and that 35mmHg ECS were superior in patients optimally adherent to ECS. Furthermore, few data are available on the very long term (>5 years).
The CELEST Long term is a prospective study, assessing the very long term risk of PTS in patients enrolled in the CELEST RCT. All patients enrolled in CELEST RCT and willing to participate are eligible and will benefit from a 7-year follow-up visit conducted over the phone.
Primary objective is to assess the proportion of patients with moderate-severe PTS defined as a patient reported Villalta score (PRVS) ≥10 or a venous leg ulcer ipsilateral to index DVT. Secondary objectives include predictors of moderate to severe PTS, impact of initial ECS strength on the development of moderate-severe PTS, impact of anticoagulant treatment (type and duration) on the development of moderate to severe PTS, proportion of PTS (defined as PRVS≥5 or ipsilateral leg ulcer) and impact of PTS on patient's QOL. Study should last 1 year and up to 288 patients may participate.
The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial CE strengths on the risk of PTS.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled and followed in the CELEST RCT*
排除标准
- •Patients who withdrew consent or died during the 2-year follow-up of the CELEST RCT.
- •Patients who decline or are unable to participate (including severe memory loss issues) to the long-term follow-up
- •CELEST RCT main inclusion/exclusion criteria were: adult (>18 years at time of enrolment) patients first unilateral acute symptomatic proximal lower limb DVT
结局指标
主要结局
Proportion of patients with moderate-severe PTS in the whole cohort
时间窗: At the phone follow-up up to 3 months
PTS defined with the patient reported Villalta score (PRVS). Moderate-severe PTS: PRVS≥10 or presence of a venous leg ulcer in the leg ipsilateral to index DVT The Villalta score consists in 11 questions (5 on subjective symptoms and 6 on objective signs). Each question is coded between 0 and 3 (0: none - 1: mild - 2: moderate - 3: severe). The total score is the sum of the 11 questions and therefore ranges from 0 to 33, where a high value indicates a high level of disability. An additional question asks about the presence of ulcers. If the calculated score is \< 15, a value of 15 is assigned to the ulcer score. The thresholds used are as follows: * presence of PTS if Villalta ≥ 5 * presence of disabling PTS (moderate, severe) if Villalta ≥ 10 * presence of severe PTS if Villalta ≥ 15
次要结局
- Proportion of patients who developed a serious adverse events (SAE) in the cohort(During the 2-year celest study and during the long-term follow-up)
- Assessment of the use of ECS after the end of the RCT in terms of use, strength, length, adherence, duration(Since enrolment in the CELEST study with focus on the period end of RCT to long-term follow-up)
- Predictors of any PTS(At the phone follow-up up to 3 months)
- Impact of initial ECS strength on the development of moderate-severe PTS(Since enrollment in the CELEST study)
- Impact of initial type of ECS on the development of moderate-severe PTS(Since enrollment in the CELEST study)
- Factors influencing the the decision to continue, stop or resume ECS(During the 2-year celest study and during the long-term follow-up)
- Impact of anticoagulant treatment on the development of moderate-severe PTS(During the 2-year celest study and during the long-term follow-up)
- Impact of PTS on patients' quality of life(At the phone follow-up up to 3 months)
- Predictors of moderate-severe PTS(Since enrolment in the CELEST CRT)
- Impact of adherence to RCT's ECS on the development of moderate-severe PTS(Since enrollment in the CELEST study)
- Proportion of patients with any PTS(At the phone follow-up up to 3 months)