Evaluation of the Efficacy of Elastic Compression in Preventing Post-thrombotic Syndrome. Randomised Non-inferiority Study for Ankle Pressure Targeted at 25 mm Hg Versus 35 mm Hg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Deep Vein Thrombosis
- Sponsor
- Laboratoires Innothera
- Enrollment
- 350
- Locations
- 29
- Primary Endpoint
- To show that elastic compression with ankle pressure targeted at 25 mm Hg is not inferior in preventing the onset of clinical post-thrombotic syndrome to a target ankle pressure of 35 mm Hg (recommended pressure being greater than 30 mm Hg)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying 30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS may be difficult to apply and to wear.
ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more comfortable. This could favor a better compliance.
CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle
Detailed Description
CELEST trial is a controlled, randomized, multicentre, non-inferiority double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle. Patients with a first acute symptomatic proximal DVT will be randomized to wear for two years either ECS applying 25mmHg of targeted pressure at the ankle or ECS applying 35mmHg of targeted pressure at the ankle. All patients will be prescribed anticoagulants for at least three months. The primary outcome will be the rate of PTS assessed with the Villalta scale in both arms of the study during the 2 years study period. Rate of compliance,severity of PTS and quality of life in both groups will constitute the main secondary outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To show that elastic compression with ankle pressure targeted at 25 mm Hg is not inferior in preventing the onset of clinical post-thrombotic syndrome to a target ankle pressure of 35 mm Hg (recommended pressure being greater than 30 mm Hg)
Time Frame: 24 months
cumulative incidence 24 months after inclusion of PTS apparition defined by the Villalta score \> or equal to 5. A visual guide will be given to investigators to assist them and standardize PTS evaluation. Investigators will receive a Villalta training during set up visits.
Secondary Outcomes
- Superiority of 25 mm Hg on the therapeutic compliance criterion(24 months)
- non inferiority of 25 mm Hg for the onset of permanent trophic disorders(3 months, 12 and 24 months)
- test for key factors in good compliance(24 months)
- superiority of targeted pressure at 35 mm Hg for compliant patients. Analysis of the primary endpoint per protocol amongst patients responding to the definition of compliance for compression scheduled by randomization(24 months)
- non inferiority of 25 mm Hg for the intensity of long term chronic venous insufficiency symptoms (12 months and 24 months)(12 and 24 months)
- non inferiority of 25 mm Hg for the onset of sequalae or post thrombotic residues on an duplex scan at 3 months, 12 and 24 months(3, 12 and 24 months)
- Adverse events(24 months)
- Subgroups analysis of the primary objective and secondary objectives according to the gender stratification criterion and age(24 months)
- superiority of 25 mmHg on 35 mmHg in preventing the onset of clinical post thrombotic syndrome(24 months)
- Non-inferiority of 25 mm Hg for changes in overall quality of life evaluated on the basis of the EUROQUOL questionnaire(3months, 12 months, 24 months)
- testing for the prognostic factors of the onset post thrombotic syndrome and comparison of the onset kinetics of post thrombotic syndrome(24 months)
- superiority of 25 mm Hg for constraints related to compression and chronic venous insufficiency quality of life (CIVIQ)(3 months, 12 months, 24 months)
- non inferiority of 25 mm Hg for the comparative evaluation of the symptomatic effect of short-term compression (pain, sensation of oedema) form baseline to 3 months(3 months)
- sensitivity analysis of primary endpoint excluding patients with a differential diagnosis can explain a Villalta score ≥ 5(24 months)