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GEKO Venous Thromboembolism Prevention Study

RecruitingNAAges 18 Years - anyAllFirstkind Ltd
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • geko™ device
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Where

18 sites
West Suffolk Hospital
Bury St Edmunds, United Kingdom
Royal United Hospital
Bath, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Fairfield General Hospital
Bury, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
Countess of Chester Hospital
Chester, United Kingdom

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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