Deep Vein ThrombosisCHAPSNCT04103112
Compression Hosiery to Avoid Post-Thrombotic Syndrome
A study testing Graduated compression stocking in people with Deep Vein Thrombosis and Deep Vein Thrombosis Leg, run by Imperial College London at 12 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Deep Vein Thrombosis Leg, Post Thrombotic Syndrome
- What is being tested?
- Graduated compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 5 Mar 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic presentation of first deep vein thrombosis, <2 weeks from diagnosis
- Imaging confirmed, lower limb deep vein thrombosis (popliteal, femoral, iliac or combination)
- Ability to give informed consent
- Age 18 or over
Who cannot join
- Life expectancy < 2 years
- Contraindication to wearing graduated compression stockings
- Previously intolerant of or already wearing graduated compression stockings for more than 1 month.
- Ankle brachial pressure index (ABPI) <0.8 or pedal pulses absent
- Bilateral deep vein thrombosis
- Previous chronic venous insufficiency (patients with existing chronic skin changes or ulceration, defined as C4,5,6 by Clinical Etiological Anatomical Pathophysiological (CEAP) classification)
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- Pre-existing post thrombotic syndrome, significant leg pain (e.g. knee arthritis, spinal claudication) or oedema (e.g. lymphoedema).
- Newly diagnosed cancer, metastatic cancer, or cancer undergoing active treatment or palliation
- Contraindication to anticoagulation
- Known allergy to fabric in compression stockings
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon
Hampshire Hospitals NHS Foundation Trust
Basingstoke
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Imperial College Healthcare NHS Trust
London, W68RF
Guy's and St Thomas' NHS Foundation Trust
London
Kings College Hospital NHS Foundation Trust
London
London North West University Healthcare NHS Trust
London
Royal Free London NHS Foundation Trust
London
East Cheshire NHS Trust
Macclesfield
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford
Salisbury Hospital NHS Foundation Trust
Salisbury
About this study
Official title: Compression Hosiery to Avoid Post-Thrombotic Syndrome (CHAPS)
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.
Read the 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.
- Being tested
- Graduated compression stocking
- Keywords
- Deep Vein Thrombosis
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated compression stockingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical care | No intervention | Standard clinical care (anticoagulation) with no graduated compression stocking |
| Graduated compression stocking and standard clinical care | Experimental | A graduated compression stocking and the standard clinical care (anticoagulation) Receives: Device: Graduated compression stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post Thrombotic Syndrome (PTS)
Measured using the validated Villalta criteria
Measured: 30 months
Secondary outcomes (6)
Venous Ulceration Incidence
Measured using the validated Villalta criteria
Measured: 30 months
Employment Status
Change in number of days working from baseline
Measured: 30 months
Change in Disease-specific and Generic Quality of Life
Measured using VEINES-QoL scale (instrument to measure quality of life in deep venous thrombosis). Two summary scores can be computed. The VEINES-QOL summary score (25 items) provides an estimate of the overall impact of deep venous thrombosis on the patient's quality of life. The VEINES-Sym summary score (10 items) measures symptom severity. Higher scores indicate better outcomes.
Measured: 18 months
Change in Disease-specific and Generic Quality of Life
Measured using EuroQoL EQ5D scale (European Quality of Life 5D instrument for measuring generic health status) . A health index on a score of 0 to 1 and the participants' self-rated health on a vertical score of zero to 100. Higher scores indicate better quality of life.
Measured: 18 months
The Proportion of Participants Who Are Adherent to Stockings and Anticoagulants
Patient self-report - at six months median follow up, the criteria for continuing CHAPS is equal to or over 70% of participants wearing stockings (monthly self-reported patient adherence questionnaire) for equal to or over 4 days per week in the intervention arm, along with a documented reorder of stockings within the last 6 months.
Measured: 30 months
Cost-effectiveness of Stocking Prescription
Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start5 Mar 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: At the request of the study's funders (NIHR-HTA) the study was terminated early due to poor recruitment in the context of the COVID-19 pandemic and unprecedented pressures faced by the NHS.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Universidad de Granada, University College, London, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103112
- Sponsor's protocol ID
- 19CX5434
- Acronym
- CHAPS
- Status last verified
- Jul 2023
- First submitted
- 19 Sep 2019
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Hosiery to Avoid Post-Thrombotic Syndrome (CHAPS)
- ClinicalTrials.gov ID
- NCT04103112
- Acronym / sponsor ID
- CHAPS / 19CX5434
- Keywords
- Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the request of the study's funders (NIHR-HTA) the study was terminated early due to poor recruitment in the context of the COVID-19 pandemic and unprecedented pressures faced by the NHS.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Edinburgh, Universidad de Granada, University College, London, University of Manchester
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 7 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard clinical care | No intervention | –Standard clinical care (anticoagulation) with no graduated compression stocking |
| Graduated compression stocking and standard clinical care | Experimental | Device: Graduated compression stockingA graduated compression stocking and the standard clinical care (anticoagulation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic presentation of first deep vein thrombosis, <2 weeks from diagnosis
- Imaging confirmed, lower limb deep vein thrombosis (popliteal, femoral, iliac or combination)
- Ability to give informed consent
- Age 18 or over
Key exclusion criteria (10 listed)
- Life expectancy < 2 years
- Contraindication to wearing graduated compression stockings
- Previously intolerant of or already wearing graduated compression stockings for more than 1 month.
- Ankle brachial pressure index (ABPI) <0.8 or pedal pulses absent
- Bilateral deep vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated compression stockingCompression 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. | Device | Graduated compression stocking and standard clinical care |
Primary outcome
Incidence of Post Thrombotic Syndrome (PTS)
Time frame: 30 months
Measured using the validated Villalta criteria
6 secondary outcomes
Venous Ulceration Incidence
Time frame: 30 months
Employment Status
Time frame: 30 months
Change in Disease-specific and Generic Quality of Life
Time frame: 18 months
Change in Disease-specific and Generic Quality of Life
Time frame: 18 months
The Proportion of Participants Who Are Adherent to Stockings and Anticoagulants
Time frame: 30 months
Cost-effectiveness of Stocking Prescription
Time frame: 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies principal investigator
Imperial College London
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated compression stocking in people with Deep Vein Thrombosis and Deep Vein Thrombosis Leg, run by Imperial College London at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post Thrombotic Syndrome (PTS) (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.