RecruitingNot ApplicableNCT05476913

GEKO Venous Thromboembolism Prevention Study

A Randomised Controlled Trial of the Effectiveness of Intermittent Surface Neuromuscular Stimulation Using the Geko™ Device Compared With Intermittent Pneumatic Compression to Prevent Venous Thromboembolism in Immobile Acute Stroke Patients


Sponsor

Firstkind Ltd

Enrollment

1,200 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This multicentre, randomised geko™ venous thromboembolism (VTE) prevention study will prospectively collect clinical data on VTE occurrences in immobile patients after stroke, who will be randomised, on a 1:1 allocation, to receive either standard of care (Intermittent Pneumatic Compression) or geko™ neuromuscular electrostimulation device. The aim is to assess the prevention of VTE during a follow-up period of 90 days (three months) post-randomisation.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria16

  • 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
  • Clinically apparent deep vein thrombosis at screening
  • 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)
  • 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
  • Pregnancy
  • Single or double leg amputations

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Interventions

DEVICEgeko™ device

Neuromuscular electrical stimulation of the peroneal nerve


Locations(18)

West Suffolk Hospital

Bury St Edmunds, Suffolk, United Kingdom

Royal United Hospital

Bath, United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

The Royal Bournemouth Hospital

Bournemouth, United Kingdom

Fairfield General Hospital

Bury, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

Countess of Chester Hospital

Chester, United Kingdom

Whiston Hospital

Liverpool, United Kingdom

Northwick Park Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

Milton Keynes University Hospital

Milton Keynes, United Kingdom

Queen's Medical Centre

Nottingham, United Kingdom

Salford Royal Hospital

Salford, United Kingdom

Stepping Hill Hospital

Stockport, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom

Yeovil Hospital

Yeovil, United Kingdom

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NCT05476913


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