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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 years or older 2. Clinical diagnosis of acute stroke (WHO criteria) 3. Within 36 hours of symptom onset 4. Not able to get up from a chair/out of bed and walk to the toilet without the help of another person Who Should NOT Join This Trial: 1. Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee 2. Unwitnessed onset with a long lie on the floor before admission 3. Clinically apparent deep vein thrombosis at screening 4. Patient is expected to require palliative care within 14 days 5. Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care. 6. 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) 7. Contraindications for the use of the geko™ device: - Allergy to hydrogel constituents 8. 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 9. Uncontrolled congestive cardiac failure 10. Pregnancy 11. Single or double leg amputations Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of acute stroke (WHO criteria) 3. Within 36 hours of symptom onset 4. Not able to get up from a chair/out of bed and walk to the toilet without the help of another person Exclusion Criteria: 1. Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee 2. Unwitnessed onset with a long lie on the floor before admission 3. Clinically apparent deep vein thrombosis at screening 4. Patient is expected to require palliative care within 14 days 5. Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care. 6. 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) 7. Contraindications for the use of the geko™ device: * Allergy to hydrogel constituents 8. 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 9. Uncontrolled congestive cardiac failure 10. Pregnancy 11. Single or double leg amputations

Treatments Being Tested

DEVICE

geko™ 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