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
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
United Kingdom
Royal United Hospital
RECRUITING
Bath
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
The Royal Bournemouth Hospital
RECRUITING
Bournemouth
Fairfield General Hospital
RECRUITING
Bury
West Suffolk Hospital
RECRUITING
Bury St Edmunds
Addenbrooke's Hospital
RECRUITING
Cambridge
Kent and Canterbury Hospital
NOT_YET_RECRUITING
Canterbury
Countess of Chester Hospital
RECRUITING
Chester
Whiston Hospital
RECRUITING
Liverpool
King's College Hospital
RECRUITING
London
Northwick Park Hospital
RECRUITING
London
Milton Keynes University Hospital
RECRUITING
Milton Keynes
Queen's Medical Centre
RECRUITING
Nottingham
Salford Royal Hospital
RECRUITING
Salford
Stepping Hill Hospital
RECRUITING
Stockport
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
New Cross Hospital
RECRUITING
Wolverhampton
Yeovil Hospital
RECRUITING
Yeovil
Contact Information
Primary
Kieron Day, DPhil
Kieron.Day@firstkindmedical.com
+44 (0) 7921 106253
Backup
Wing To, PhD
wing.to@firstkindmedical.com
+44 (0) 7827 612109
Time Frame
Start Date: 2023-07-06
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 1200
Treatments
Experimental: geko™ T-3 interventional
The geko™ device will be applied bilaterally as soon as possible after randomisation and each geko™ device will be used to deliver one 24-hour dose. Devices will be worn continuously and changed every 24 hours. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.
No_intervention: Intermittent Pneumatic Compression (IPC)
Control treatment will be IPC using NHS approved devices as used for standard clinical care. They will be applied to both legs as soon as possible after randomisation. They will not be changed unless damaged or soiled. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospitals of North Midlands NHS Trust, University of California, Keele University, Bournemouth University, National Institute for Health Research, United Kingdom
Leads: Firstkind Ltd