GEKO Venous Thromboembolism Prevention Study
Recruiting now · Not applicable
Conditions studied: Stroke, Acute, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
In brief
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.
Key facts
- Study ID
- NCT05476913
- Run by
- Firstkind Ltd
- People needed
- 1200
- Starts
- 2023-07-06
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2025-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yeovil Hospital — Yeovil, United Kingdom (enrolling)
- Royal United Hospital — Bath, United Kingdom (enrolling)
- Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom (enrolling)
- The Royal Bournemouth Hospital — Bournemouth, United Kingdom (enrolling)
- Fairfield General Hospital — Bury, United Kingdom (enrolling)
- Addenbrooke's Hospital — Cambridge, United Kingdom (enrolling)
- West Suffolk Hospital — Bury St Edmunds, Suffolk, United Kingdom (enrolling)
- Countess of Chester Hospital — Chester, United Kingdom (enrolling)
- Whiston Hospital — Liverpool, United Kingdom (enrolling)
- Northwick Park Hospital — London, United Kingdom (enrolling)
- King's College Hospital — London, United Kingdom (enrolling)
- Milton Keynes University Hospital — Milton Keynes, United Kingdom (enrolling)
- Queen's Medical Centre — Nottingham, United Kingdom (enrolling)
- Salford Royal Hospital — Salford, United Kingdom (enrolling)
- Stepping Hill Hospital — Stockport, United Kingdom (enrolling)
- Royal Stoke University Hospital — Stoke-on-Trent, United Kingdom (enrolling)
- New Cross Hospital — Wolverhampton, United Kingdom (enrolling)
- Kent and Canterbury Hospital — Canterbury, United Kingdom
Full record on ClinicalTrials.gov
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