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Clinical Trials in the UK / NCT05476913
Recruiting Not applicable

GEKO Venous Thromboembolism Prevention Study

NCT05476913 · tracked via the Priya Life Science UK tracker
Sponsor
Firstkind Ltd
Phase
Not applicable
Started
2023-07-06
Last updated
2025-03-04

Condition(s) studied

Stroke, AcuteVenous ThromboembolismDeep Vein ThrombosisPulmonary Embolism

Investigational drug(s) / intervention(s)

geko™ device

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)

FacilityCityRegionStatus
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

More Firstkind Ltd trials in the UK

Geko™ Cross Therapy Registry - Wound Active, not recruiting

Other trials for the same condition

Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study Recruiting
Microvisk Continuous Blood Donation Study Starting soon
Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism Active, not recruiting
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis 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.

View NCT05476913 on ClinicalTrials.gov ↗ ← All trials in the UK