Plain English Summary
Background and study aims
Patients with a deep vein thrombosis (DVT) may develop long-term symptoms, such as 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 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?
Patients aged 18 and over at participating centres recently diagnosed with a deep vein thrombosis
What does the study involve?
Participants are 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 are asked to wear whilst they are awake as much as possible for between 6-30 months. Patients are aware of which group they are in, but are 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, there are a variety of free aids to help people use them as well as training on how to put them on. In addition, there are cotton stockings to wear in the summer months, more elegant stockings that can be worn out for women, and stockings that resemble socks for men.
What are the possible benefits and risks of participating?
Those patients who receive a stocking may have a lower risk of long-term pain, swelling and ulceration. They will also have the benefit of peer support via an online anonymous group and receive additional education about deep vein thrombosis. Those patients who are not asked to wear a stocking will still benefit from longer, enhanced follow up after deep vein thrombosis. Participants in both groups of the trial will be monitored closely for any complications of deep vein thrombosis, so that they can quickly be detected and acted upon. All patients will also have the arteries in their legs checked for adequate flow down to the feet.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
May 2019 to December 2022
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Rebecca Lawton
chapstrial@imperial.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Rebecca Lawton
ORCID ID
Contact details
Imperial College London
Section of Vascular Surgery
Room 14
4th Floor East Wing
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)203 311 5204
chapstrial@imperial.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
NCT04103112
Protocol/serial number
CPMS: 42347; HTA 17/147/47
Study information
Scientific title
Compression hosiery to avoid post-thrombotic syndrome
Acronym
CHAPS; version 1.0
Study hypothesis
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 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 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.
Ethics approval
Approved 14/10/2019, London - Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, Barlow House 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; Tel: +44 (0)2071048127; Email: nrescommittee.london-bloomsbury@nhs.net), ref: 19/LO/1585
Study design
Randomised; Interventional; Design type: Prevention, Device
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Post-thrombotic syndrome
Intervention
Participants are 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 are asked to wear whilst they are awake as much as possible for between 6-30 months. Patients are aware of which group they are in, but are 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, there are a variety of free aids to help people use them as well as training on how to put them on. In addition, there are cotton stockings to wear in the summer months, more elegant stockings that can be worn out for women, and stockings that resemble socks for men.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Incidence of Post Thrombotic Syndrome (PTS) using the validated Villalta criteria over a median 18-month follow-up
Secondary outcome measures
1. Venous ulceration incidence measured by the validated Villalta criteria over a median 18-month follow-up
2. Employment status (change in number of days working from baseline)
3. Disease-specific and generic quality of life measured using VEINES-QoL and EuroQoL EQ5D scales at baseline, 6 months, 12 months and end of study visit
4. Adherence to stockings and anticoagulants measured using patient self-report over a median 18-month follow-up
5. Cost-effectiveness of stocking prescription - incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis
Overall trial start date
01/05/2019
Overall trial end date
31/12/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Symptomatic presentation of first deep vein thrombosis, < 2 weeks from diagnosis
2. Imaging confirmed, lower limb deep vein thrombosis (popliteal, femoral, iliac or combination)
3. Ability to give informed consent
4. Age 18 or over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 864; UK Sample Size: 864
Participant exclusion criteria
1. Life expectancy < 2 years
2. Contraindication to wearing graduated compression stockings
3. Previously intolerant of or already wearing graduated compression stockings for more than 1 month
4. Ankle brachial pressure index (ABPI) < 0.8 or pedal pulses absent
5. Bilateral deep vein thrombosis
6. Previous chronic venous insufficiency (patients with existing chronic skin changes or ulceration, defined as C4,5,6 by CEAP classification)
7. Pre-existing post thrombotic syndrome, significant leg pain (e.g. knee arthritis, spinal claudication) or oedema (e.g. lymphoedema)
8. Newly diagnosed cancer, metastatic cancer, or cancer undergoing active treatment or palliation
9. Contraindication to anticoagulation
10. Known allergy to fabric in compression stockings
Recruitment start date
18/11/2019
Recruitment end date
31/10/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imperial College Healthcare NHS Trust
St. Marys Hospital
Praed Street
London
W2 1NY
United Kingdom
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Trial participating centre
King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom
Trial participating centre
Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
University Hospitals Birmingham NHS Foundation Trust
Trust HQ, PO Box 9551
Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2TH
United Kingdom
Trial participating centre
Royal Free London NHS Foundation Trust
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
Trial participating centre
London North West University Healthcare NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Trial participating centre
Hampshire Hospitals NHS Foundation Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Trial participating centre
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom
Trial participating centre
North Bristol NHS Trust
Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Trial participating centre
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
Imperial College of Science, Technology and Medicine
Sponsor details
c/o Becky Ward
Joint Research Compliance Office
Room 215
Level 2
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)207 594 9459
becky.ward@imperial.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
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. The researchers are working with the charity Thrombosis UK and the results of the trial will be made available on their website.
1. A protocol paper is currently being drafted and will be submitted to a medical journal
2. Peer-reviewed scientific journals
3. Conference presentation
4. Publication on website
5. Submission to regulatory authorities
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2023
Participant level data
Other
Basic results (scientific)
Publication list