GEKO Venous Thromboembolism Prevention Study

Sponsor
Firstkind Ltd
Study ID
NCT05476913
Status
Recruiting
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Conditions

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Stroke, Acute
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • geko™ device — DEVICE
    Neuromuscular electrical stimulation of the peroneal nerve

Study Details

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.

Key Dates

First listed
Jul 27, 2022
Start date
Jul 6, 2023
Status verified
Feb 2025
Primary completion
Apr 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: geko™ T-3 interventional
    The geko™ device will be applied bilaterally as soon as possible after randomisation and each geko™ device will be used to deliver one 24-hour dose. Devices will be worn continuously and changed every 24 hours. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.
  • No Intervention: Intermittent Pneumatic Compression (IPC)
    Control treatment will be IPC using NHS approved devices as used for standard clinical care. They will be applied to both legs as soon as possible after randomisation. They will not be changed unless damaged or soiled. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.

Primary Outcome Measure

Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE). [ Time Frame: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation. ]

Central Contacts

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