Elastic Compression Stockings for Prevention of Post-thrombotic Syndrome (CELEST)

Innothera

Status

Completed

Conditions

Post-thrombotic Syndrome

Deep Vein Thrombosis

Treatments

Device: 25mmHg ECS

Device: 35 mmHg ECS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01578122

CVE301-10 (Themas) : DCIC/1028

2010-A01078-31 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

350 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Patient (male/female) at least 18 years old
Patient presenting with an initial episode of proximal deep vein thrombosis (DVT) confirmed by an additional examination (echo-Doppler scan) taken no more than 8 days previously :

the proximal character defined by a DVT from the collecting trunk extending from the tibial-peroneal trunk to the inferior vena cava inclusive the unilateral character concerns only the proximal part. Patients with a distal DVT on the contralateral member the day of diagnosis can be included The notion of initial episode concerns only the proximal part. Patients with a preceding DVT limited to distal part can be included

with no trophic disorders at baseline (CEAP class 4, 5 or 6 excluded)
with or without pulmonary embolism
Patient capable of benefiting from anticoagulant therapy of at least 3 months duration
Available to participate in a clinical trial with a 24-month follow-up period and for which a delivery of study products may be possible throughout its participation (delivery possible only in Metropolitan France)
Life expectancy greater than 24 months
Volunteer to take part in the study, having signed the consent form after receiving sufficient information and the information leaflet
Person affiliated to social security or the recipient of a similar scheme.

non inclusion criteria

Patients with at least one of these contraindications to compression treatment:
- phlegmasia cerulea dolens,
- septic thrombosis,
- product intolerance, allergic reaction to one of the components
- Arteritis obliterans stage III and IV of the lower limbs (IPS<0.6),
- Micro-angiopathy, advanced diabetes,
- Decompensated heart failure,
- Skin infections: anti-infective treatment must precede compression therapy,
- Weeping skin diseases of the leg.
- Compression treatment technically impossible during the study
Patients presenting with bilateral venous thrombosis of the lower limbs.
Patient having received fibrinolytic treatment, mechanical thrombo-aspiration or venous repermeation surgery for venous thrombosis justifying inclusion
Patients having undergone mechanical interruption of the inferior vena cava.
Patients for whom long-term elastic compression for the treatment of lymphatic venous insufficiency (patients with lymphoedema), for instance, is indicated prior to DVT. Patients with elastic compression for primary thromboprophylaxis of thromboembolic disease (TED) are eligible.
Patients presenting with oedema unrelated to venous insufficiency or in whom oedema is likely to develop within 2 years.
Patients receiving diuretic treatment for more than 3 months due to heart failure.
Pregnant women
Person deprived of liberty by a legal or administrative decision, person under legal protection.
Patient currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol