NCT04103112

Compression Hosiery to Avoid Post-Thrombotic Syndrome

Compression Hosiery to Avoid Post-Thrombotic Syndrome (CHAPS)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Vein Thrombosis
• Deep Vein Thrombosis Leg
• Post Thrombotic Syndrome

Interventions

Type	Name	Description
DEVICE	Graduated compression stocking	Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment. The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.

Timeline

• Start date: 2020-03-05
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-09-25
• Last updated: 2024-03-07
• Results posted: 2024-03-07

Locations

12 sites across 1 country: United Kingdom