The GRACE multi-centre randomised controlled trial

• Research type

  Research Study

• Full title

  Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention

• IRAS ID

  333539

• Contact name

  Alun Davies

• Contact email

  a.h.davies@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  3 years, 2 months, 31 days

• Research summary

  Hospital-acquired thrombosis (HAT) is defined as any VTE within 90 days of hospital
  admission, encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE).
  HAT represents a significant cause of preventable death, with over 12,000 people dying each year from hospital-associated VTE in the UK. Previous studies report that the risk of untreated high-risk surgical patients developing HAT is as high as 40-60% in orthopaedic patients and 15-40% in general surgery patients. For these patients at highest risk of VTE, key prevention strategies include extended pharmacological thromboprophylaxis (EDPTP) prescribed beyond hospital discharge and provision of graduated compression stockings (GCS). There is compelling evidence to support the use of pharmacological thromboprophylaxis, however, there is little evidence to support the use of additional GCS, which can cause complications in as many as 5% of patients. Providing GCS in this group costs the NHS a minimum of £8.3 million per annum.

  The GRACE trial aims to establish whether:-
  1. patients undergoing surgical procedures requiring EDPTP benefit from additional
  GCS to prevent VTE
  2. patients receiving GCS experience an increased rate of adverse events

  Methods: 8608 participants will be randomised to one of two thromboprophylaxis strategies:
  1. EDPTP* in addition to GCS, or
  2. EDPTP alone

  and followed up for 90 days post surgery.

  Included participants will be those age 18 and over undergoing surgical intervention who are deemed to require extended duration thromboprophylaxis.

  Exclusion criteria includes those with a known thrombophilia, prescribed therapeutic anticoagulation or have a contraindication to EDTPT or GCS.

  The primary outcome is imaging confirmed lower limb DVT with or without symptoms, or PE with symptoms <90 days from surgery.

  Participants will be follow-up up remotely at 7, between 21 and 35 days and 90 days post surgery. They will also have a lower limb duplex scan between 21 and 35 days to detect any DVTs not causing symptoms.

• REC name

  Wales REC 3

• REC reference

  23/WA/0350

• Date of REC Opinion

  19 Dec 2023

• REC opinion

  Favourable Opinion