CHAPS Trial

Sponsor: Imperial College London (ref: 19CX5434); IRAS: 263041; Approved by London Bloomsbury REC 14/01/2020

Objective

To measure the difference in incidence of post-thrombotic syndrome at a median of 18 months follow up after first, acute DVT between standard clinical care (anticoagulation) and the intervention arm (a graduated compression stocking and the standard clinical care (anticoagulation)).

Design

Multi-centre, pragmatic, blinded outcome assessment, randomised controlled trial. The trial will follow patients up for a median of 18 months (range 6 – 30 months) and will be conducted in approximately 11 secondary care Trusts in the United Kingdom.

Sample size

A total of 864 patients will be recruited, in 1:1 allocation between the two randomised arms.

Eligibility criteria 

Inclusion Criteria

• Symptomatic presentation of first deep vein thrombosis, <3 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 C5 and C6 by 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

Primary endpoint

The primary outcome is any incidence of Post Thrombotic Syndrome (PTS) using the validated Villalta criteria (Appendix 1) over a median 18 month follow up (range 6 to 30 months). The primary outcome will be assessed on up to three occasions (6 and 12 months post randomisation, and at study end) depending on an individual participant’s length of follow up (minimum 6 and maximum 30 months)

Secondary endpoints

• Venous ulceration incidence as measured by the validated Villalta criteria
• Employment status-(change in number of days working from baseline)
• Change in disease-specific and generic quality of life- VEINES-QoL and EuroQoL EQ5D scales from baseline over 6m, 12m and end of study visit
• Adherence to stockings and anticoagulants- patient self-report
• Cost-effectiveness of stocking prescription- Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis

Randomisation (performed through RedCap)

Consenting eligible patients will be randomised through RedCap.

If you have any problems logging on to RedCap please contact the team via  redcap.ectu@ed.ac.uk

Study documents

• CHAPS Protocol‌‌
• CHAPS Patient Information Sheet
• Process Evaluation Patient Information Sheet 
• Other ethics approved documents
• Patient qualitative questionnaires
• Patient video (for patients in the stockings arm)

Newsletters

• CHAPS Newsletter June 2020
• CHAPS Newsletter October 2020
• CHAPS Newsletter April 2021
• CHAPS Newsletter October 2021
• CHAPS Newsletter March 2022