TerminatedNot Applicable

Compression Hosiery to Avoid Post-Thrombotic Syndrome

Stopped: At the request of the study's funders (NIHR-HTA) the study was terminated early due to poor recruitment in the context of the COVID-19 pandemic and unprecedented pressures faced by the NHS.

United Kingdom152 participantsStarted 2020-03-05

Plain-language summary

Patients with a deep vein thrombosis (DVT) may develop long-term symptoms, e.g. lifelong leg pain, skin changes and occasionally ulceration, known as post-thrombotic syndrome (PTS). This affects about half of people with a history of DVT. This randomised study aims to show whether the regular use of a compression stocking after DVT in the leg, prevents long-term pain, swelling and ulceration. Currently small trials show varied results and a large trial is required to answer the question.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Symptomatic presentation of first deep vein thrombosis, \<2 weeks from diagnosis * Imaging confirmed, lower limb deep vein thrombosis (popliteal, femoral, iliac or combination) * Ability to give informed consent * Age 18 or over Exclusion Criteria: * Life expectancy \< 2 years * Contraindication to wearing graduated compression stockings * Previously intolerant of or already wearing graduated compression stockings for more than 1 month. * Ankle brachial pressure index (ABPI) \<0.8 or pedal pulses absent * Bilateral deep vein thrombosis * Previous chronic venous insufficiency (patients with existing chronic skin changes or ulceration, defined as C4,5,6 by Clinical Etiological Anatomical Pathophysiological (CEAP) classification) * Pre-existing post thrombotic syndrome, significant leg pain (e.g. knee arthritis, spinal claudication) or oedema (e.g. lymphoedema). * Newly diagnosed cancer, metastatic cancer, or cancer undergoing active treatment or palliation * Contraindication to anticoagulation * Known allergy to fabric in compression stockings

What they're measuring

Incidence of Post Thrombotic Syndrome (PTS)

Timeframe: 30 months

Trial details

NCT IDNCT04103112

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2023-07-21