Clinical trial NCT06046807: Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Thrombotic Syndrome
Keywords: Post thrombotic syndrome
Elastic compression stockings
long-term follow-up
Deep vein Thrombosis
Lead sponsor: Laboratoires Innothera
Sponsor class: INDUSTRY
Collaborators: name: Floralis
First posted: 2023-09-21
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were enrolled in the CELEST RCT

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.

Eligibility criteria: Inclusion Criteria:

* Patients enrolled and followed in the CELEST RCT\*

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients with moderate-severe PTS in the whole cohort
timeFrame: At the phone follow-up up to 3 months
Secondary outcomes:
measure: Predictors of moderate-severe PTS
timeFrame: Since enrolment in the CELEST CRT
measure: Impact of initial ECS strength on the development of moderate-severe PTS
timeFrame: Since enrollment in the CELEST study
measure: Impact of initial type of ECS on the development of moderate-severe PTS
timeFrame: Since enrollment in the CELEST study
measure: Impact of adherence to RCT's ECS on the development of moderate-severe PTS
timeFrame: Since enrollment in the CELEST study
measure: Assessment of the use of ECS after the end of the RCT in terms of use, strength, length, adherence, duration
timeFrame: Since enrolment in the CELEST study with focus on the period end of RCT to long-term follow-up
measure: Factors influencing the the decision to continue, stop or resume ECS
timeFrame: During the 2-year celest study and during the long-term follow-up
measure: Impact of anticoagulant treatment on the development of moderate-severe PTS
timeFrame: During the 2-year celest study and during the long-term follow-up
measure: Proportion of patients with any PTS
timeFrame: At the phone follow-up up to 3 months
measure: Predictors of any PTS
timeFrame: At the phone follow-up up to 3 months
measure: Proportion of patients who developed a serious adverse events (SAE) in the cohort
timeFrame: During the 2-year celest study and during the long-term follow-up
measure: Impact of PTS on patients' quality of life
timeFrame: At the phone follow-up up to 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: ROLLAND
Study officials:
affiliation: University Grenoble Alpes, France
name: Jean Luc Bosson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, Canada
name: Jean Philippe Galanaud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Makedonov I, Kahn SR, Galanaud JP. Prevention and Management of the Post-Thrombotic Syndrome. J Clin Med. 2020 Mar 27;9(4):923. doi: 10.3390/jcm9040923.
citation: Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available. Erratum In: Circulation. 2015 Feb 24;131(8):e359. doi: 10.1161/CIR.0000000000000185.
citation: Galanaud JP, Genty-Vermorel C, Barrellier MT, Becker F, Jabbour V, Blaise S, Bura-Riviere A, Comte A, Grange C, Guenneguez H, Maufus M, Ouvry P, Richaud C, Rolland C, Schmidt J, Sevestre MA, Verriere F, Bosson JL; CELEST trial investigators. 25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial. Lancet Haematol. 2022 Dec;9(12):e886-e896. doi: 10.1016/S2352-3026(22)00247-2.
citation: Galanaud JP, Genty-Vermorel C, Rolland C, Comte A, Ouvry P, Bertaina I, Verriere F, Bosson JL. Compression stockings to prevent postthrombotic syndrome: Literature overview and presentation of the CELEST trial. Res Pract Thromb Haemost. 2020 Oct 30;4(8):1239-1250. doi: 10.1002/rth2.12445. eCollection 2020 Nov.