Condition category
Circulatory System
Date applied
28/10/2019
Date assigned
30/10/2019
Last edited
30/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

28/10/2019: Trial's existence confirmed by the NIHR.