geko™ device: Neuromuscular electrical stimulation of the peroneal nerve
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE). — From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation. Determine the number of patients diagnosed to have a VTE (DVT and PE), comparing the two groups: geko™ device compared to IPC standard of care. Asymptomatic DVT will be diagnosed using above knee compression Doppler (Compression Duplex Ultrasound) and PE will be diagnosed using ventilation perfusion scan or by computer tomography pulmonary angiogram (CTPA). Compression Dopplers will be conducted any time there is a clinical suspicion of DVT. Above knee compression Dopplers will be conducted at 7 days and 14 days after randomisation, or at patient discharge if patient recovers earlier than 7 d and 14 days post-randomisation.
Trial sites (18)
Facility
City
Region
Status
West Suffolk Hospital
Bury St Edmunds
Suffolk
Recruiting
Royal United Hospital
Bath
United Kingdom
Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham
United Kingdom
Recruiting
The Royal Bournemouth Hospital
Bournemouth
United Kingdom
Recruiting
Fairfield General Hospital
Bury
United Kingdom
Recruiting
Addenbrooke's Hospital
Cambridge
United Kingdom
Recruiting
Kent and Canterbury Hospital
Canterbury
United Kingdom
Not Yet Recruiting
Countess of Chester Hospital
Chester
United Kingdom
Recruiting
Whiston Hospital
Liverpool
United Kingdom
Recruiting
Northwick Park Hospital
London
United Kingdom
Recruiting
King's College Hospital
London
United Kingdom
Recruiting
Milton Keynes University Hospital
Milton Keynes
United Kingdom
Recruiting
Queen's Medical Centre
Nottingham
United Kingdom
Recruiting
Salford Royal Hospital
Salford
United Kingdom
Recruiting
Stepping Hill Hospital
Stockport
United Kingdom
Recruiting
Royal Stoke University Hospital
Stoke-on-Trent
United Kingdom
Recruiting
New Cross Hospital
Wolverhampton
United Kingdom
Recruiting
Yeovil Hospital
Yeovil
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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