Graduated compression stockings for patients with a deep vein thrombosis to prevent long-term symptoms, known as post-thrombotic syndrome
| ISRCTN | ISRCTN73041168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73041168 |
| ClinicalTrials.gov number | NCT04103112 |
| Secondary identifying numbers | CPMS: 42347; HTA 17/147/47 |
- Submission date
- 28/10/2019
- Registration date
- 30/10/2019
- Last edited
- 26/09/2022
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
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 2023
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Rebecca Lawton
chapstrial@imperial.ac.uk
Contact information
Scientific
Imperial College London
Section of Vascular Surgery
Room 14, 4th Floor East Wing
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
| Phone | +44 (0)203 311 5204 |
|---|---|
| chapstrial@imperial.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Compression hosiery to avoid post-thrombotic syndrome |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 01/05/2019 |
| Overall study end date | 31/12/2023 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 864; UK Sample Size: 864 |
| Total final enrolment | 152 |
| 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 exclusion criteria | Current participant exclusion criteria as of 21/12/2021: 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 C5 or C6 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 Previous 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 | 01/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Praed Street
London
W2 1NY
United Kingdom
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
London
SE5 9RS
United Kingdom
Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2TH
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Nethermayne
Basildon
SS16 5NL
United Kingdom
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Cumberland Infirmary
Infirmary Street
Carlisle
CA2 7HY
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
E Level North Wing
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Treliske
Truro
TR1 3HD
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Haemostasis and Thrombosis department D Floor East Block
Derby Road
Nottingham
NG7 2UH
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Glan Clwyd Hospital
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Sponsor information
University/education
c/o Becky Ward
Joint Research Compliance Office
Room 215, Level 2
Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)207 594 9459 |
|---|---|
| becky.ward@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 12/04/2021 | 14/04/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/09/2022: Total final enrolment added.
23/09/2022: The following changes were made to the trial record:
1. The study has been stopped at the request of the funder due to recruitment issues resulting from the COVID-19 pandemic.
2. The trial participating centres were updated to remove Cambridge University Hospitals NHS Foundation Trust and add Nottingham University Hospital NHS Trust, Derby Teaching Hospitals NHS Foundation Trust, York Teaching Hospital NHS Foundation Trust and Betsi Cadwaladr University Health Board.
10/01/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2022 to 01/01/2023.
2. The overall trial end date was changed from 31/12/2022 to 31/12/2023.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
21/12/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2021 to 01/01/2022.
2. The participant exclusion criteria have been updated.
3. The trial participating centres "East Cheshire NHS Trust", "Salisbury NHS Foundation Trust", "Barking, Havering and Redbridge University Hospitals NHS Trust", "Maidstone and Tunbridge Wells NHS Trust", "North Cumbria Integrated Care NHS Foundation Trust", "Hull University Teaching Hospitals NHS Trust,", "Countess of Chester Hospital NHS Foundation Trust", and "University Hospital Southampton NHS Trust", "Yeovil District Hospital NHS Foundation Trust", "Royal Cornwall Hospital NHS Trust", and "Bolton NHS Foundation Trust" have been added, and the trial participating centre "North Bristol NHS Trust" has been removed.
20/09/2021: Internal review.
14/04/2021: Publication reference added.
04/01/2021: The trial website has been added.
01/05/2020: Due to current public health guidance, recruitment for this study has been paused.
28/10/2019: Trial's existence confirmed by the NIHR.
