Long-term assessment of post thrombotic syndrome in patients
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.
This study is trying to see how many people develop post thrombotic syndrome over seven years after taking part in a previous trial, and if certain types of compression stockings can help prevent it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 288 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Laboratoires Innothera Industry-sponsored |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT06046807 on ClinicalTrials.gov |
What this trial studies
The CELEST Long Term study is a prospective observational study that aims to evaluate the long-term risk of post thrombotic syndrome (PTS) in patients who participated in the CELEST double-blind randomized controlled trial. Participants will undergo a 7-year follow-up via phone to assess the prevalence of moderate to severe PTS using the Villalta score. The study also seeks to identify predictors of PTS and examine the effects of different strengths of elastic compression stockings on PTS development. Up to 288 patients are expected to participate in this comprehensive follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who were enrolled in the CELEST RCT and are willing to participate in the long-term follow-up.
Not a fit: Patients who withdrew consent or died during the CELEST RCT, or those unable to participate due to severe memory loss, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of post thrombotic syndrome and improve management strategies for affected patients.
How similar studies have performed: While the CELEST RCT provided initial insights, this long-term follow-up is novel and aims to fill gaps in understanding the long-term implications of PTS.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Grenoble
- Rolland — Grenoble, France (Recruiting)
Study contacts
- Principal investigator: Jean Luc Bosson, MD, PhD — University Grenoble Alpes, France
- Study coordinator: Carole Rolland, MSc
- Email: carole.rolland@univ-grenoble-alpes.fr
- Phone: 04 76 76 50 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.