GEKO Venous Thromboembolism Prevention Study

Other illness

• Clinically apparent deep vein thrombosis at screening
• Contraindications for the use of the geko™ device:
  • Allergy to hydrogel constituents
• Contraindications to IPC:
  • Severe peripheral vascular disease
  • Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
  • Severe oedema
  • Leg deformities making appropriate fitting impossible
• Uncontrolled congestive cardiac failure

Other

• Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee
• Unwitnessed onset with a long lie on the floor before admission
• Patient is expected to require palliative care within 14 days
• Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.
• Patient has recently been involved in or is currently involved in a clinical trial for either a medical device or medicinal product, within the past 3 months, with the exception: if co-enrolment is not considered to impact adverse events or outcomes in the opinion of the Chief Investigator. (A live document containing a list of approved studies will be included in a reference document made available to all study sites and available upon request)
• Pregnancy
• Single or double leg amputations

• Age 18 years or older
• Clinical diagnosis of acute stroke (WHO criteria)
• Within 36 hours of symptom onset
• Not able to get up from a chair/out of bed and walk to the toilet without the help of another person