GAPS - Graduated compression as an Adjunct to Pharmacoprophylaxis in S
Research type
Research Study
Full title
Examining the benefit of graduated compression stockings as an adjunct to low dose low molecular\nweight heparin in the prevention of venous thromboembolism in elective surgical inpatients identified\nas moderate or high risk for venous thromboembolism – a multi-centre randomised controlled trial
IRAS ID
188256
Contact name
Alun H Davies
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN13911492
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Individuals attending hospital to undergo operations are at risk of developing blood clots in the legs (deep vein thrombosis or DVT). The consequences of developing a blood clot in the leg include swelling of the leg, future problems with the skin of that leg including a leg ulcer, and importantly the possibility of the blood clot travelling up to the patient’s lungs (pulmonary embolism or PE), causing sudden death in a small proportion of cases. DVT and PE are known collectively as venous thromboembolism or VTE.\n\nImportance of preventing VTE in patients having surgery is widely recognised. Srategies are in place to minimise VTE: blood-thinning with injections, and wearing elastic stockings to help stop blood sitting in the leg veins where it can clot. Evidence for using elastic stockings to prevent VTE has been challenged, with a lack of evidence for the additional benefit of elastic stockings over and above the benefit of blood-thinning. If elastic stockings reduce VTE over and above blood thinners, these benefits need to be weighed against disadvantages of elastic stockings (discomfort, restricting blood flow to the leg, blistering, cost, staff to assist patients in wearing).\n\nA trial has been designed whereby patients are randomly assigned to receive either elastic stockings and blood thinning medicines, or blood-thinning medicines alone. The number of cases of VTE occurring up to 90 days following surgery will be determined, as well as potential disadvantages of elastic stockings. It has been calculated that 2236 patients will be required to participate in the study for sufficient information to confidently answer the scientific question.\n\nIf elastic stockings were found not to reduce the risk of clots in individuals given blood-thinning medicines, they would no longer need to be used in these surgical patients, reducing stockings’ side effects and saving approximately £63.1million per year.
REC name
London - Bromley Research Ethics Committee
REC reference
16/LO/0015
Date of REC Opinion
8 Feb 2016
REC opinion
Further Information Favourable Opinion