NCT05476913 GEKO Venous Thromboembolism Prevention Study
| NCT ID | NCT05476913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Firstkind Ltd |
| Condition | Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2023-07-06 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2023-07-06 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Christine Roffe, MD FRCP FESO
PRINCIPAL INVESTIGATOR
Keele University, University Hospitals of North Midlands NHS Trust
Frequently Asked Questions
Who can join the NCT05476913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05476913 currently recruiting?
Yes, NCT05476913 is actively recruiting participants. Contact the research team at Kieron.Day@firstkindmedical.com for enrollment information.
Where is the NCT05476913 trial being conducted?
This trial is being conducted at Bury St Edmunds, United Kingdom, Bath, United Kingdom, Birmingham, United Kingdom, Bournemouth, United Kingdom and 11 additional locations.
Who is sponsoring the NCT05476913 clinical trial?
NCT05476913 is sponsored by Firstkind Ltd. The principal investigator is Christine Roffe, MD FRCP FESO at Keele University, University Hospitals of North Midlands NHS Trust. The trial plans to enroll 1,200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.