Compression Hosiery to Avoid Post-Thrombotic Syndrome

Deep Vein Thrombosis Clinical Trial

— CHAPS  

Official title:

Compression Hosiery to Avoid Post-Thrombotic Syndrome (CHAPS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04103112
• Other study ID #: 19CX5434
• Status: Terminated
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Deep Vein Thrombosis Leg
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Graduated compression stocking
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.

Locations

Country	Name	City	State
United Kingdom	Basildon and Thurrock University Hospitals NHS Foundation Trust	Basildon
United Kingdom	Hampshire Hospitals NHS Foundation Trust	Basingstoke
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Kings College Hospital NHS Foundation Trust	London
United Kingdom	London North West University Healthcare NHS Trust	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	East Cheshire NHS Trust	Macclesfield
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Barking, Havering and Redbridge University Hospitals NHS Trust	Romford
United Kingdom	Salisbury Hospital NHS Foundation Trust	Salisbury

Sponsors (5)

Lead Sponsor	Collaborator
Imperial College London	Universidad de Granada, University College, London, University of Edinburgh, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Post Thrombotic Syndrome (PTS)	Measured using the validated Villalta criteria	30 months
Secondary	Venous Ulceration Incidence	Measured using the validated Villalta criteria	30 months
Secondary	Employment Status	Change in number of days working from baseline	30 months
Secondary	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.	18 months
Secondary	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.	18 months
Secondary	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.	30 months
Secondary	Cost-effectiveness of Stocking Prescription	Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis	30 months