Compares a leg stimulation device with compression to prevent blood clots after stroke
Tests the Geko device against standard compression in immobile adults with acute stroke.
Plain-language title generated from the registry record
Registry title: GEKO Venous Thromboembolism Prevention Study
Key facts
- Where
- Bath, Birmingham, Bournemouth, Bury, Bury St Edmunds, Cambridge, Canterbury, Chester, Liverpool, London, Milton Keynes, Nottingham, Salford, Stockport, Stoke-on-Trent, Wolverhampton, and Yeovil, United KingdomSee the 18 sites
Where in United Kingdom
- Royal United HospitalBath, United KingdomTaking people
- Queen Elizabeth Hospital BirminghamBirmingham, United KingdomTaking people
- The Royal Bournemouth HospitalBournemouth, United KingdomTaking people
- Fairfield General HospitalBury, United KingdomTaking people
- West Suffolk HospitalBury St Edmunds, United KingdomTaking people
- Addenbrooke's HospitalCambridge, United KingdomTaking people
- Kent and Canterbury HospitalCanterbury, United KingdomNot yet recruiting
- Countess of Chester HospitalChester, United KingdomTaking people
- Whiston HospitalLiverpool, United KingdomTaking people
- King's College HospitalLondon, United KingdomTaking people
- Northwick Park HospitalLondon, United KingdomTaking people
- Milton Keynes University HospitalMilton Keynes, United KingdomTaking people
- Queen'S Medical CentreNottingham, United KingdomTaking people
- Salford Royal HospitalSalford, United KingdomTaking people
- Stepping Hill HospitalStockport, United KingdomTaking people
- Royal Stoke University HospitalStoke-on-Trent, United KingdomTaking people
- New Cross HospitalWolverhampton, United KingdomTaking people
- Yeovil HospitalYeovil, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Firstkind Ltd
- Trial code
- NCT05476913
- Record updated
- 4 March 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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.