GEKO Venous Thromboembolism Prevention Study
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
Firstkind Ltd
1,200 participants
Jul 6, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Age 18 years or older
- Clinical diagnosis of acute stroke (WHO criteria)
- Within 36 hours of symptom onset
- Not able to get up from a chair/out of bed and walk to the toilet without the help of another person
Exclusion Criteria16
- Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee
- Unwitnessed onset with a long lie on the floor before admission
- Clinically apparent deep vein thrombosis at screening
- Patient is expected to require palliative care within 14 days
- Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.
- 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)
- Contraindications for the use of the geko™ device:
- Allergy to hydrogel constituents
- 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
- Uncontrolled congestive cardiac failure
- Pregnancy
- Single or double leg amputations
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Interventions
Neuromuscular electrical stimulation of the peroneal nerve
Locations(18)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05476913