CHAPS; version 1.0
Research type
Research Study
Full title
Compression Hosiery to Avoid Post-Thrombotic Syndrome
IRAS ID
263041
Contact name
Alun Davies
Contact email
Sponsor organisation
Joint Research Compliance Office, Imperial College London
Duration of Study in the UK
3 years, 2 months, 31 days
Research summary
Every year 1 in 1000 persons in the UK 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 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 UK NICE recommendations are to avoid stockings after DVT, 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.
To help participants remember to wear stockings they have access to an educational video, a Facebook support group and weekly SMS reminders.
After the trial, patients do not need to wear their stockings. As some patients find putting on a stocking tricky, we have a variety of free aids to help people use them as well as training on how to put them on. In addition we have cotton stockings to wear in summer months, more elegant stockings that can be worn out for women and stockings that resemble socks for men.
Patients and relatives have been involved in the design of the research, drafting this summary and will sit on our trial committees. This will mean that patients have a voice during the running of the trial. For example, this allows the voice of participants to be heard on the trial steering committee. We are working with the charity Thrombosis UK and the results of the trial will be made available on their website.
Lay summary of study results:
Between March 2020 and May 2022, 152 patients were recruited to the study. As the trial was closed early, around one-quarter of participants did not reach the first follow up visit at 6-months. Follow up data was therefore available for 56 participants in the intervention arm and 55 participants in the control arm at a minimum of 6 months. Post-thrombotic syndrome (PTS) occurred in 51% of participants in the control arm, and 30% of participants in the intervention arm. Of all patients who received intervention, no severe PTS was identified. There were no safety concerns related to the use of compression stockings. Participants reported that they wore their stockings for a mean of 6 days per week, with 60% wearing them for more than eight hours per day. Stockings were re-ordered at 6 months by 64% of participants. These results suggest that wearing compression stockings regularly may lower the risk of PTS, however further research is needed.REC name
London - Bloomsbury Research Ethics Committee
REC reference
19/LO/1585
Date of REC Opinion
14 Oct 2019
REC opinion
Favourable Opinion