GEKO Venous Thromboembolism Prevention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirstkind Ltd
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- geko™ device
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Firstkind Ltd
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Keele University
Collaborator
University Hospitals of North Midlands NHS Trust
Collaborator
University of California
Collaborator
Bournemouth University
Collaborator
Source ClinicalTrials.gov