Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).
- Conditions
- Post Thrombotic Syndrome
- Interventions
- Other: Phone call
- Registration Number
- NCT06046807
- Lead Sponsor
- Laboratoires Innothera
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 288
- Patients enrolled and followed in the CELEST RCT*
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 25mmHg ECS Phone call Subjects with first proximal DVT allocated to wear 25 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT 35mmHg ECS Phone call Subjects with first proximal DVT allocated to wear 35 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT
- Primary Outcome Measures
Name Time Method Proportion of patients with moderate-severe PTS in the whole cohort 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
- Secondary Outcome Measures
Name Time Method 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 SAEs assessed are death, venous thromboembolic recurrence, major bleeding and peripheral arterial disease. SAEs are defined according to the International Society on Thrombosis and Haemostasis criteria. These events will be adjudicated by the study adjudication committee
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 Description of the use of ECS among study participants since the end of their participation in the CELEST RCT
Predictors of any PTS At the phone follow-up up to 3 months Predictors of PTS (defined as a PRVS≥5 or presence of a venous leg ulcer in the leg ipsilateral to index DVT) in the whole cohort
Impact of initial ECS strength on the development of moderate-severe PTS Since enrollment in the CELEST study Comparison of proportion of moderate-severe PTS between patients randomized in the 25mmHg ECS vs. 35mmHg ECS group
Impact of initial type of ECS on the development of moderate-severe PTS Since enrollment in the CELEST study Comparison of proportion of moderate-severe PTS between patients who chose to wear above knee vs. below knee ECS during CELEST RCT
Factors influencing the the decision to continue, stop or resume ECS During the 2-year celest study and during the long-term follow-up Description of the reasons that led to the decision to continue, stop or resume ECS
Impact of anticoagulant treatment on the development of moderate-severe PTS During the 2-year celest study and during the long-term follow-up Comparison of proportion of moderate-severe PTS according to type and duration of anticoagulant treatment during CELEST RCT
Impact of PTS on patients' quality of life At the phone follow-up up to 3 months Comparison of QOL scores according to the presence or absence of PTS and its severity; QOL will be assessed using CIVIQ-20 questionnaire
Predictors of moderate-severe PTS Since enrolment in the CELEST CRT Predictors of moderate-severe PTS in the whole cohort
Impact of adherence to RCT's ECS on the development of moderate-severe PTS Since enrollment in the CELEST study Comparison of proportion of moderate-severe PTS according to adherence to ECS during CELEST RCT
Proportion of patients with any PTS At the phone follow-up up to 3 months PTS present if PRVS≥5 or presence of a venous leg ulcer in the leg ipsilateral to index DVT
Trial Locations
- Locations (1)
ROLLAND
🇫🇷Grenoble, France