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
2 other identifiers
interventional
1,200
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Typical duration for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 27, 2022
CompletedStudy Start
First participant enrolled
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMarch 4, 2025
February 1, 2025
1.8 years
July 21, 2022
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
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.
From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.
Secondary Outcomes (9)
Device Acceptability
At 14 days after randomisation
Device effectiveness
At 30 days after randomisation
Leg pain level using a Numerical Rating Scale (NRS) score
At 90 days after randomisation
Disability using the modified Rankin score
At 90 days after randomisation
Health related quality of life using EQ-5D-5L
At 90 days after randomisation
- +4 more secondary outcomes
Study Arms (2)
geko™ T-3 interventional
EXPERIMENTALThe 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.
Intermittent Pneumatic Compression (IPC)
NO INTERVENTIONControl 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.
Interventions
Neuromuscular electrical stimulation of the peroneal nerve
Eligibility Criteria
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
- Severe oedema
- Leg deformities making appropriate fitting impossible
- Uncontrolled congestive cardiac failure
- Pregnancy
- Single or double leg amputations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Firstkind Ltdlead
- National Institute for Health Research, United Kingdomcollaborator
- Keele Universitycollaborator
- University Hospitals of North Midlands NHS Trustcollaborator
- University of Californiacollaborator
- Bournemouth Universitycollaborator
Study Sites (18)
West Suffolk Hospital
Bury St Edmunds, Suffolk, IP29 5DN, United Kingdom
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW, United Kingdom
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Fairfield General Hospital
Bury, BL9 7TD, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Countess of Chester Hospital
Chester, CH2 1UL, United Kingdom
Whiston Hospital
Liverpool, L35 5DR, United Kingdom
Northwick Park Hospital
London, HA1 3UJ, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Milton Keynes University Hospital
Milton Keynes, MK6 5LD, United Kingdom
Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Stepping Hill Hospital
Stockport, SK2 7JE, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Yeovil Hospital
Yeovil, BA21 4AT, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Roffe, MD FRCP FESO
Keele University, University Hospitals of North Midlands NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The trial will be single blind for the primary outcome. Devices will be taken off before participants have Doppler imaging at 7 days and 14 days. Data on VTE will be taken by a blinded researcher using information available on hospital information systems.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2022
First Posted
July 27, 2022
Study Start
July 6, 2023
Primary Completion
April 30, 2025
Study Completion
June 30, 2025
Last Updated
March 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share