Using geko device to prevent blood clots in stroke patients
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
NA · Firstkind Ltd · NCT05476913
This study is testing if the geko™ device can help prevent blood clots in stroke patients who can’t move around, compared to the standard treatment they usually get.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Firstkind Ltd (industry) |
| Locations | 18 sites (Bury St Edmunds, Suffolk and 17 other locations) |
| Trial ID | NCT05476913 on ClinicalTrials.gov |
What this trial studies
This multicentre study aims to evaluate the effectiveness of the geko™ device in preventing venous thromboembolism (VTE) in immobile patients following an acute stroke. Participants will be randomly assigned to receive either the standard treatment of Intermittent Pneumatic Compression (IPC) or the geko™ device, which uses neuromuscular electrostimulation to enhance blood circulation. The study will follow patients for 90 days to assess VTE occurrences and will include regular Doppler exams to monitor leg circulation. The goal is to determine if the geko™ device offers a superior alternative to IPC for VTE prevention in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute stroke and are immobile within 36 hours of symptom onset.
Not a fit: Patients who are expected to require palliative care within 14 days or those with clinically apparent deep vein thrombosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for preventing potentially life-threatening blood clots in stroke patients who are unable to move.
How similar studies have performed: Previous studies have shown promising results for the geko™ device in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bury St Edmunds, Suffolk and 17 other locations
- West Suffolk Hospital — Bury St Edmunds, Suffolk, United Kingdom (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)
Study contacts
- Principal investigator: Christine Roffe, MD FRCP FESO — Keele University, University Hospitals of North Midlands NHS Trust
- Study coordinator: Kieron Day, DPhil
- Email: Kieron.Day@firstkindmedical.com
- Phone: +44 (0) 7921 106253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Acute, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, geko, intermittent pneumatic compression, DVT prophylaxis