GEKO Venous Thromboembolism Prevention Study (NCT05476913) | Clinical Trial Compass
RecruitingNot Applicable
GEKO Venous Thromboembolism Prevention Study
United Kingdom1,200 participantsStarted 2023-07-06
Plain-language summary
This multicentre, randomised gekoâ„¢ 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 gekoâ„¢ neuromuscular electrostimulation device. The aim is to assess the prevention of VTE during a follow-up period of 90 days (three months) post-randomisation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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:
✕
What they're measuring
1
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
Timeframe: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.