Clinical trial NCT04103112: Compression Hosiery to Avoid Post-Thrombotic Syndrome
Official title: Compression Hosiery to Avoid Post-Thrombotic Syndrome (CHAPS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deep Vein Thrombosis
Deep Vein Thrombosis Leg
Post Thrombotic Syndrome
Keywords: Deep Vein Thrombosis
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: Universidad de Granada
name: University College, London
name: University of Manchester
First posted: 2019-09-25
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Every year 1 in 1000 persons in the United Kingdom are diagnosed with a blood clot in the leg veins (deep vein thrombosis). In just under half of those with deep vein thrombosis, leg pain, swelling and skin breakdown (ulcers) can occur, a lifelong condition called post-thrombotic syndrome. This impacts upon a person's ability to work, their confidence and independence. In most patients there is no effective treatment and they lose income from unemployment. Ulcers, if they occur, require bandaging that needs to be changed twice weekly.

Treatment guidelines for deep vein thrombosis do not currently include the use of a compression stockings. They can sometimes be difficult to put on for those who cannot bend down, the stockings can slip or roll down, or become uncomfortable in hot weather. Stockings cost the National Health Service (NHS) approximately £50 every 6 months. The evidence for stockings comes from two early trials comparing patients wearing a stocking to those who did not.

There was a large benefit in both these trials for wearing a stocking, with no major side effects. In 2014, a Canadian group published a trial comparing wearing a compression stocking to wearing a non-compressive stocking. The rates of post-thrombotic syndrome were identical. The Canadian trial also suggested that only half of patients actually wear stockings, one reason the trial may have shown no difference. The Canadian trial suggested that stockings did not prevent future thrombosis or help leg pain. Whilst United Kingdom National Institute for Health and Care Excellence (NICE) recommendations are to avoid stockings after deep vein thrombosis, European recommendations are to still wear them. The contradictory results of these three trials have led us to design the CHAPS trial.

The aim of CHAPS is to confirm whether there is a real benefit of wearing stockings in addition to the standard treatment for deep vein thrombosis, which is blood thinning medication.

Adults with a first deep vein thrombosis can join the trial. They will be randomly allocated to receive either blood thinning medication, or blood thinning medication and an additional compression stocking. This is a tight, custom fitted stocking that they will be asked to wear whilst they are awake as much as possible for between 6-30 months. Patients will be aware of which group they are in, but will be asked not to wear the stocking when they come for their assessment. This keeps the researchers impartial.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Post Thrombotic Syndrome (PTS)
timeFrame: 30 months
Secondary outcomes:
measure: Venous Ulceration Incidence
timeFrame: 30 months
measure: Employment Status
timeFrame: 30 months
measure: Change in Disease-specific and Generic Quality of Life
timeFrame: 18 months
measure: Change in Disease-specific and Generic Quality of Life
timeFrame: 18 months
measure: The Proportion of Participants Who Are Adherent to Stockings and Anticoagulants
timeFrame: 30 months
measure: Cost-effectiveness of Stocking Prescription
timeFrame: 30 months
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals NHS Foundation Trust
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Macclesfield
country: United Kingdom
facility: East Cheshire NHS Trust
city: Newcastle
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Romford
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
city: Salisbury
country: United Kingdom
facility: Salisbury Hospital NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Alun H Davies
role: PRINCIPAL_INVESTIGATOR
References: