Examining the benefit of graduated compression stockings as an adjunct to low dose low molecular weight heparin in the prevention of venous thromboembolism in elective surgical inpatients identified as moderate or high risk for venous thromboembolism a multi-centre randomised controlled trial

Shalhoub J, Lawton R, Hudson J, Baker C, Bradbury A, Dhillon K, Everington T, Gohel MS, Hamady Z, Hunt BJ, Stansby G, Warwick D, Norrie J, Davies AH
Record ID 32016000040
English
Authors' objectives: Individuals attending hospital to undergo operations are at risk of developing blood clots in the legs (deep vein thrombosis or DVT). These blood clots occur for a number of reasons, related to immobility, changes occuring in the blood and any damage to the veins in which the blood travels. 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 (which is troublesome and costly to manage and cure), and importantly the possibility of the blood clot dislodging and travelling up to the patient s lungs (pulmonary embolism or PE). This latter scenario can result in difficulties in oxygen entering the bloodstream from the lungs and also has the potential to place strain on the heart. In a proportion of cases of PE, sudden death may result. DVT and PE are known collectively as venous thromboembolism or VTE. The importance of preventing VTE in patients having surgery is widely recognised and strategies are in place to minimise the development of VTE. The two main ways that have been employed are: thinning the blood with regular injections, and wearing elastic stockings to help stop blood sitting in the leg veins where it can clot. The evidence for using elastic stockings to prevent VTE has recently been challenged. Additionally, there is a lack of evidence for the additional benefit of elastic stockings over and above the benefit of blood thinning. If elastic stockings were to reduce VTE over and above blood thinners, these benefits need to be weighed against a number of risks and disadvantages of elastic stockings, including: discomfort, restricting the blood flow to the leg, blistering, cost, and the requirement for staff to assist patients in wearing. A trial has been designed whereby patients are randomly assigned by a computer program 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 (as above). It has been calculated that 2236 patients will be required to enroll and participate in the study for sufficient information to confidently answer the scientific question, and these patients will be invited to participate at a number of hospitals. It is hoped that in embarking on this study, we will be able to: Determine if elastic stockings offer an additional benefit to patients who are receiving blood thinners Look at the side effects related to elastic stockings and blood thinners Produce important recommendations for VTE prevention that reduces side effects (without causing a rise in VTE) and improves patients quality of life If elastic stockings were found not to reduce the risk of clots in individuals give blood thinning medicines, they would no longer need to be used in these surgical patients. This would reduce the side effects of the stockings, and also save the NHS in England approximately £63.1 million per year. We will ensure that the study findings and updated practice guidelines are shared widely so the results can be acted on.
Details
Project Status: Completed
Year Published: 2020
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England
MeSH Terms
  • Postoperative Complications
  • Anticoagulants
  • Heparin, Low-Molecular-Weight
  • Inpatients
  • Stockings, Compression
  • Thromboembolism
  • Venous Thromboembolism
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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