Using geko device to prevent blood clots in stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.